MEDICINES SUSPENDED FROM THE JUNE 2020 DRUG REGISTER

COUNTRY
NDA LOCAL GENERIC ALTERNATIVE
LICENSE NAME OF STRENGTH OF DOSAGE REGISTRATI
S/N REGISTRATIO TECHNICAL NAME OF MANUFACTURER PACK SIZE COMMENTS MANUFACTURE
HOLDER DRUG OF DRUG MANUFACT FORM ON DATE
N NUMBER REPRESENTATIVE DRUG R
URE

1 NDA/MAL/H F. HOFFMANN LABOREX AVASTIN BEVACIZUM 100 MG/ F.HOFFMANN-LA SWITZERLAN PARENTERAL 1.0X4.0 ML 7/1/2016 GMP EXPIRED ROCHE
DP/4275 LA-ROCHE UGANDA 100MG/4ML AB 4ML ROCHE LTD- D ORDINARY VIAL ON 24/11/2018 DIAGNOSTICS
LIMITED GRENZACHERSTRASSE VIALS FOR LINES GMBH-
124,CH- 4070 BASEL Tablets Hard SANDHOFER
Gelatin Capsules STRASSE 116 D-
SVP Solutions 68305
Lyophilized Vial MANNHEIM
Pre-filled GERMANY F.
syringes HOFFMANN LA-
ROCHE-
2 NDA/MAL/H F. HOFFMANN LABOREX AVASTIN BEVACIZUM 400MG/4M F.HOFFMANN-LA SWITZERLAN PARENTERAL 1.0X16.0 7/1/2016 GMP EXPIRED ROCHE
DP/4284 LA-ROCHE UGANDA 400MG/4ML AB L ROCHE LTD- D ORDINARY ML VIAL ON 24/11/2018 DIAGNOSTICS
LIMITED GRENZACHERSTRASSE VIALS FOR LINES GMBH-
124,CH- 4070 BASEL Tablets Hard SANDHOFER
Gelatin Capsules STRASSE 116 D-
SVP Solutions 68305
Lyophilized Vial MANNHEIM
Pre-filled GERMANY F.
3 NDA/MAL/H ACINO PHARMA GOODMAN COAMOX CO- 400MG+47 LEK SWITZERLAN ORAL LIQUID 1.0X70.0 7/1/2008 GMP EXPIRED NONE
DP/3079 AG INTERNATIONAL ACINO 457 AMOXICLAV MG/ 5ML PHARMACEUTICALS- D ORDINARY ML BOTTLE ON 17-02-2020
LTD CHILD/ENFA PREVALJE SITE, DRY FOR B-
NT PERZONALI 47, S1- SUSPENSION LACTAM(PENICIL
2391, PREVALJE S/SYRUPS/DR LINS):TABLETS
OPS AND POWDERS
FOR ORAL
SUSPENSION

4 NDA/MAL/H ACINO PHARMA GOODMAN CO-AMOX CO- 125MG+31. LEK SWITZERLAN ORAL LIQUID 1.0X100.0 7/1/2008 GMP EXPIRED NONE
DP/3080 AG INTERNATIONAL ACINO AMOXICLAV 25MG/ PHARMACEUTICALS- D ORDINARY ML BOTTLE ON 17-02-2020
LTD 156.25 5ML PREVALJE SITE, DRY FOR B-
INFANT PERZONALI 47, S1- SUSPENSION LACTAM(PENICIL
2391, PREVALJE S/SYRUPS/DR LINS):TABLETS
OPS AND POWDERS
FOR ORAL
SUSPENSION

5 NDA/MAL/H AGOG PHARMA GITTOES AGOCAL CALCIUM 300MG AGOG PHARMA LTD- INDIA ORAL SOLID 1.0X1000.0 7/1/2001 GMP FAILURE OF NONE
DP/5495 LTD PHARMACEUTICA TABLETS LACTATE PLOT NO.33,SECTOR ORDINARY TABLET FPP
LS LIMITED II,VASAI,TALUKA INDL TABLETS CONTAINER MANUFACTURER
CO-OP ESTATE ,1.0X10.0X1 FOR PARTICULAR
LTD,GAURAI 0.0 TABLET PRODUCT ON 25-
PADA,VASAI(E)DIST.T BLISTER 26/02/2019
HANE INDIA
6 NDA/MAL/H THE ARAB P'CAL GOODMAN ZOCIN AZITHROMY 200MG/5M ARAB JORDAN ORAL LIQUID 1.0X15.0 7/1/2001 CLOSED NONE
DP/2307 MANUFACTIRIN INTERNATIONAL SUSPENSION CIN L PHARMACEUTICAL ORDINARY ML BUSINESS IN
G CO. LTD MANUFACTURING DRY BOTTLE,1.0 UGANDA
INDUSTRIES --KING SUSPENSION X22.5 ML
ABDULAH 2ND STREET S/SYRUPS/DR BOTTLE
/ INDUSTRIAL AREA OPS
BUILDING NO. 1 AL-
BUHAIRAH / SULT-
7 NDA/MAL/H THE ARAB P'CAL GOODMAN ZOCIN AZITHROMY 250MG ARAB JORDAN ORAL SOLID 1.0X6.0 7/1/1999 CLOSED NONE
DP/4017 MANUFACTIRIN INTERNATIONAL CAPSULES CIN PHARMACEUTICAL ORDINARY CAPSULE BUSINESS IN
G CO. LTD MANUFACTURING CAPSULES BLISTER UGANDA
INDUSTRIES --KING
ABDULAH 2ND STREET
/ INDUSTRIAL AREA
BUILDING NO. 1 AL-
BUHAIRAH / SULT-
8 NDA/MAL/H ACINO PHARMA GOODMAN LOFRAL 5 AMLODIPIN 5MG ATLANTIC PHARMA SWITZERLAN ORAL SOLID 1.0X3.0X10. 7/1/2007 GMP EXPIRED Acino Pharma
DP/3210 AG INTERNATIONAL E SA,-ZONA INDUSTRIAL D ORDINARY 0 TABLET ON 2017-10-02 AG-
LTD DA ABRUHEIRA PORTUGAL TABLETS BLISTER Dornacherstrass
(Non Beta- e 114, CH-4147
Aesch
Capsules (Non
Beta-lactam)
9 NDA/MAL/H ACINO PHARMA GOODMAN LOFRAL 10 AMLODIPIN 10MG ATLANTIC PHARMA SWITZERLAN ORAL SOLID 1.0X3.0X10. 7/1/2007 GMP EXPIRED Acino Pharma
DP/3424 AG INTERNATIONAL E SA,-ZONA INDUSTRIAL D ORDINARY 0 TABLET ON 2017-10-02 AG-
LTD DA ABRUHEIRA PORTUGAL TABLETS BLISTER Dornacherstrass
(Non Beta- e 114, CH-4147
Aesch
Capsules (Non
Beta-lactam)
10 NDA/MAL/V BAYER EAST KWEWAYO (U) IPLUS IVERMECTIN 1%W/V + BAYER NEW ZEALAND NEW PARENTERAL 1.0X500.0 7/1/2016 GMP EXPIRED NONE
DP/4189 AFRICA LTD VET PHARMACY + 10%W/V LTD-CNR WIRI ZEALAND ORDINARY S ML VIAL ON 2018-06-15
LIMITED CLORSULON STATION ROAD & C VIALS FOR NBL SVP
HOBILL AVENUE Injections,LVP
MANUKAU AUCKLAND Injections, Oral
liquids Topical
liquids Creams
and pastes
Powders and
granules

11 NDA/MAL/H DEWYX DEWYX M-ENERGEX MULTI- MULTI- BIO GALLERY-SDN MALAYSIA ORAL SOLID 1.0X50.0X1. 8/1/2010 ADULTERATED NONE
HP/8841 PHARMACEUTIC PHARMACEUTICA CAPSULES INGREDIENT INGREDIEN BHD ORDINARY 0 CAPSULE WITH TADALAFIL
ALS LIMITED LS LIMITED T CAPSULES BLISTER,1.0
X25.0X1.0
CAPSULE
BLISTER
12 NDA/MAL/H DEWYX DEWYX M-ENERGEX MULTI- MULTI- BIO GALLERY-SDN MALAYSIA ORAL SOLID 1.0X10.0X2 8/1/2010 ADULTERATED NONE
HP/8842 INTERNATIONAL PHARMACEUTICA COFFEE INDREDIENT INGREDIEN BHD ORDINARY 0.0 G WITH TADALAFIL
LTD LS LIMITED T POWDERS SACHET

13 NDA/MAL/H BODENE (PTY) SURGIPHARM (U) PETOGEN- MEDROXYP 150MG/ML BODENE (PTY) LTD SOUTH PARENTERAL 1.0X100.0X 7/1/2011 GMP EXPIRED NONE
DP/4607 LIMITED LIMITED FRESEMIOS ROGESTERO TRADING AS- AFRICA ORDINARY I 1.0 ML VIAL ON 2010-07-16
NE INTRAMED 6-GIBAUD M VIALS FOR Sterile - SVP
ROAD KORSTEN drip bags, SVP -
ELIZABETH 6001 Ampoules, Vials
Non Sterile -
Continous
Ambulatory
Peritoneal
14 NDA/MAL/H CADILA HEALTH ABACUS PHARMA R-LOC RANITIDINE 150MG CADILA HEALTH CARE INDIA ORAL SOLID 1.0X10.0X1 7/1/1998 SUSPENDED DUE NONE
DP/2377 CARE LIMITED (AFRICA) LIMITED TABLETS LTD-KUNDAIM ORDINARY 0.0 TABLET TO IMPURITY
INDUSTRIAL ESTATE, TABLETS BLISTER FOUND IN API
PLOT NO. 203-213,
KUNDAIM,GOA-403
115, INDIA

15 NDA/MAL/H CADILA HEALTH ABACUS PHARMA R-LOC RANITIDINE 25MG/ML CADILA HEALTHCARE INDIA PARENTERAL 1.0X5.0X2.0 7/1/2010 SUSPENDED DUE NONE
DP/2827 CARE LIMITED (AFRICA) LIMITED LTD SARKHEJ-BAVLA ORDINARY ML TO IMPURITY
NH NO.8A MORAIYA AMPOULES AMPOULE FOUND IN API
TAL SANAND DISTRICT
AHMEDABAD 382210

16 NDA/MAL/H DEV LIFE PLANET EPIRYTE 300 SODIUM 300 MG CENTURION INDIA ORAL SOLID 1.0X10.0X1 11/27/2019 FAILED GMP ON NONE
DP/7505 CORPORATION PHARMACEUTICA VALPOATE LABORATORIES PVT ORDINARY 0.0 TABLET THE 24TH-
LS UGANDA LTD LTD-PLOT NO 2, BIO- ENTERIC- BLISTER,1.0 25TH/06/2019
TECH PARK, COATED X100.0 FOR NBL LINES;
MANJUSAR, TAL-SAVLI TABLETS TABLET Tablets and HGC
VADODARA, GUJARAT BOTTLE
INDIA
17 NDA/MAL/H DEV LIFE PLANET EPIRYTE 500 SODIUM 500 MG CENTURION INDIA ORAL SOLID 1.0X10.0X1 11/27/2019 FAILED GMP ON NONE
DP/7506 CORPORATION PHARMACEUTICA VALPOATE LABORATORIES PVT ORDINARY 0.0 TABLET THE 24TH-
LS UGANDA LTD LTD-PLOT NO 2, BIO- ENTERIC- BLISTER,1.0 25TH/06/2019
TECH PARK, COATED X100.0 FOR NBL LINES;
MANJUSAR, TAL-SAVLI TABLETS TABLET Tablets and HGC
VADODARA, GUJARAT BOTTLE
INDIA
18 NDA/MAL/H METRO METRO TETRACYCLI TETRACYCLI 250MG CSPC OUYI CHINA ORAL SOLID 1.0X1000.0 7/1/2013 GMP EXPIRED NONE
DP/1289 PHARMACEUTIC PHARMACEUTICA NE NE PHARMACEUTICAL ORDINARY CAPSULE ON THE
ALS LIMITED LS LIMITED HYDROCHLO CO.LTD. LIMITED-NO. CAPSULES CONTAINER 7/3/2015 FOR
RIDE 276, WEST ,1.0X10.0X1 LINES Non-Beta
ZHONGSTAN ROAD, 0.0 Lactam •Tablets
SHIJIAZHUANG, CHINA CAPSULE (coated and
BLISTER,1.0 uncoated)
X10.0X100. •Capsules (Hard
19 NDA/MAL/H MISSION JOINT MEDICAL PRAZIQUANT PRAZIQUAN 600MG CSPC OUYI CHINA ORAL SOLID 1.0X1000.0 7/1/2013 GMP EXPIRED NONE
DP/1746 PHARMA A/S STORE (UPMB - EL TEL USP PHARMACEUTICAL ORDINARY TABLET ON THE
UCMB) CO.LTD. LIMITED-NO. TABLETS CONTAINER 7/3/2015 FOR
276, WEST LINES Non-Beta
ZHONGSTAN ROAD, Lactam •Tablets
SHIJIAZHUANG, CHINA (coated and
uncoated)
•Capsules (Hard
20 NDA/MAL/H ROYAL PHARMA ROYAL PHARMA BENZATHINE BENZATHIN 2400000 CSPC ZHONGNUO CHINA PARENTERAL 1.0X2.4 MU 7/1/2002 FACILITY NO.188 NONE
DP/2223 2011 LIMITED PENICILLIN E I.U PHARMACEUTICAL ORDINARY VIAL and 47 NO
INJECTION PENICILLIN (SHIJIAZHUANG) CO, DRY VIALS LONGER
LTD.-NO.47 EXIST.ONLY
FENGSHOU ROAD, NO.88 EXISTS
SHIJIAZHUANG CITY,
CHINA.
21 NDA/MAL/H METRO METRO INDOMETHA INDOMETH 25MG CSPC OUYI CHINA ORAL SOLID 1.0X10.0X1 7/1/2011 GMP EXPIRED NONE
DP/2592 PHARMACEUTIC PHARMACEUTICA CIN ACIN PHARMACEUTICAL ORDINARY 0.0 ON THE
ALS LIMITED LS LIMITED CO.LTD. LIMITED-NO. CAPSULES CAPSULE 7/3/2015 FOR
276, WEST BLISTER,1.0 LINES Non-Beta
ZHONGSTAN ROAD, X100.0X10. Lactam •Tablets
SHIJIAZHUANG, CHINA 0 CAPSULE (coated and
BLISTER uncoated)
•Capsules (Hard
Gelatin) •SVP
Liquids (in glass
ampoules) •SVP
Powders (in glass
vials) Beta
Lactam –
Cephalosporin:
•SVP powders
22 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA STREPTOMY STREPTOMY 1GM CSPC ZHONGUO CHINA PARENTERAL 1.0X5.0X1.0 7/1/2011 FACILITY NO.188 NONE
DP/2725 (U) LTD (U) LIMITED CIN CIN (SHIJIAZHUANG) ORDINARY X10.0 VIAL and 47 NO
SULPHATE SULPHATE PHARMACEUTICAL DRY VIALS CARTON LONGER
FOR CO.LTD-NO. 188 EXIST.ONLY
INJECTION GONGNONG NO.88 EXISTS

23 NDA/MAL/H METRO METRO DICLOFENAC DICLOFENA 25MG/ML CSPC OUYI CHINA PARENTERAL 1.0X10.0X1 7/1/2011 GMP EXPIRED NONE
DP/2989 PHARMACEUTIC PHARMACEUTICA C PHARMACEUTICAL ORDINARY 0.0X3.0 ML ON THE
ALS LIMITED LS LIMITED CO.LTD-NO. 276, AMPOULES AMPOULE 7/3/2015 FOR
WEST ZHONGSTAN LINES Non-Beta
ROAD, SHIJIAZHUANG, Lactam •Tablets
CHINA (coated and
uncoated)
•Capsules (Hard
24 NDA/MAL/H MISSION JOINT MEDICAL AMOXICILLIN AMOXICILLI 250MG CSPC ZHONGNUO CHINA ORAL SOLID 1.0X1000.0 7/1/2010 FACILITY NO.188 NONE
DP/2999 PHARMA A/S STORE (UPMB - N PHARMACEUTICAL ORDINARY CAPSULE and 47 NO
INDIA UCMB) TRIHYDRATE (SHIJIAZHUANG) CO. CAPSULES CONTAINER LONGER
LTD-NO. 6 HYANXING EXIST.ONLY
RD ZNONGHU NO.88 EXISTS
SHIJIAZHUANG
25 NDA/MAL/H ROYAL PHARMA ROYAL PHARMA BENZYLPENI BENZYLPENI 1000000 CSPC ZHONGNUO CHINA PARENTERAL 1.0X1.0 MU 7/1/2002 FACILITY NO.188 NONE
DP/3817 2011 LIMITED CILLIN CILLIN I.U PHARMACEUTICAL ORDINARY VIAL and 47 NO
INJECTION SODIUM (SHIJIAZHUANG) CO, DRY VIALS LONGER
LTD.-NO.47 EXIST.ONLY
FENGSHOU ROAD, NO.88 EXISTS
SHIJIAZHUANG CITY,
CHINA.
26 NDA/MAL/H MISSION JOINT MEDICAL FORTIFIED PROCAINE 4MIU
CSPC ZHONGNUO CHINA PARENTERAL 1.0X50.0 7/1/2007 FACILITY NO.188 NONE
DP/3937 PHARMA STORE (UPMB - PROCAINE PENICILLIN PHARMACEUTICAL ORDINARY VIAL and 47 NO
UCMB) PENICILLIN (SHIJIAZHUANG) CO, VIALS CARTON LONGER
FOR LTD .-NO. 188 EXIST.ONLY
INJECTION GONGNONG ROAD NO.88 EXISTS
AND NO.47
FENGSHOU ROAD,
SHIJIAZHUANG CITY,
27 NDA/MAL/H METRO METRO GENTAMICIN GENTAMICI 40MG/ML CSPC OUYI CHINA PARENTERAL 1.0X10.0X1 7/1/2011 GMP EXPIRED NONE
DP/5006 PHARMACEUTIC PHARMACEUTICA SULPHATE N SULPHATE PHARMACEUTICAL ORDINARY 0.0X2.0 ML ON THE
ALS LIMITED LS LIMITED CO.LTD-NO. 276, AMPOULES AMPOULE 7/3/2015 FOR
WEST ZHONGSTAN LINES Non-Beta
ROAD, SHIJIAZHUANG, Lactam •Tablets
CHINA (coated and
uncoated)
•Capsules (Hard
28 NDA/MAL/H METRO METRO DOXYCYCLIN DOXYCYCLI 100 MG CSPC OUYI INDIA ORAL SOLID 1.0X1000.0 7/1/2013 GMP EXPIRED NONE
DP/5568 PHARMACEUTIC PHARMACEUTICA E NE PHARMACEUTICAL ORDINARY CAPSULE ON THE
ALS LIMITED LS LIMITED CO. LIMITED.-NO. CAPSULES CONTAINER 7/3/2015 FOR
276, WEST ,1.0X10.0X1 LINES Non-Beta
ZHONGSHAN ROAD, 0.0 Lactam •Tablets
SHIJIAZHUANG CAPSULE (coated and
BLISTER,1.0 uncoated)
X10.0X100. •Capsules (Hard
29 NDA/MAL/H RENE RENE PHARMACY LEVATEX LEVAMISOL 40MG CYANO PHARMA(P)- INDIA ORAL SOLID 500.0 7/1/1997 FAILED GMP ON NONE
DP/1867 PHARMACY(R) LTD TABLETS E 115-C IND ESTATE ORDINARY TABLET 27-11-18 FOR
LTD.. HYDROCHL POLOGROUND, TABLETS CONTAINER Non-Beta
ORIDE INDORE 452015 ,1.0X10.0X3 Lactam: •
.0 TABLET Tablets (coated
BLISTER and uncoated)
30 NDA/MAL/H RENE RENE PHARMACY ADSOCARB ACTIVATED 250MG CYANO PHARMA(P)- INDIA ORAL SOLID 1.0X100.0 7/1/1997 FAILED GMP ON NONE
DP/2061 PHARMACY(R) LTD TABLETS CHARCOAL 115-C IND ESTATE ORDINARY TABLET 27-11-18 FOR
LTD.. POLOGROUND, TABLETS CONTAINER Non-Beta
INDORE 452015 ,1.0X10.0X1 Lactam: •
0.0 TABLET Tablets (coated
BLISTER and uncoated)

31 NDA/MAL/H RENE RENE PHARMACY PHENOBARBI PHENOBARB 30MG CYANO PHARMA(P)- INDIA ORAL SOLID 1.0X1000.0 7/1/1997 FAILED GMP ON NONE
DP/2806 INDUSTRIES LTD TONE ITONE 115-C IND ESTATE ORDINARY TABLET 27-11-18 FOR
LIMITED TABLETS POLOGROUND, TABLETS CONTAINER Non-Beta
INDORE 452015 ,1.0X10.0X1 Lactam: •
0.0 TABLET Tablets (coated
BLISTER and uncoated)

32 NDA/MAL/H CYANO RENE PHARMACY PROMETHAZI PROMETHA 25MG CYANO PHARMA(P)- INDIA ORAL SOLID 1.0X1000.0 7/1/2001 FAILED GMP ON NONE
DP/3526 PHARMA(P) LTD NE TABLETS ZINE 115-C IND ESTATE ORDINARY TABLET 27-11-18 FOR
HYDROCHL POLO GROUND TABLETS CONTAINER Non-Beta
ORIDE INDORE ,1.0X10.0X1 Lactam: •
0.0 TABLET Tablets (coated
BLISTER and uncoated)

33 NDA/MAL/H CYANO RENE PHARMACY CYANO IRON FERROUS 200MG CYANO PHARMA(P)- INDIA ORAL SOLID 1.0X1000.0 7/1/2001 FAILED GMP ON NONE
DP/4781 PHARMA(P) LTD TABLETS SULPHATE 115-C IND ESTATE ORDINARY TABLET 27-11-18 FOR
POLO GROUND TABLETS CONTAINER Non-Beta
INDORE ,1.0X10.0X1 Lactam: •
0.0 TABLET Tablets (coated
BLISTER and uncoated)

34 NDA/MAL/H CYANO RENE PHARMACY METOCLOPR METOCLOP 10MG CYANO PHARMA(P)- INDIA ORAL SOLID 1.0X10.0X1 7/1/2001 FAILED GMP ON NONE
DP/4817 PHARMA(P) LTD AMIDE RAMIDE 115-C IND ESTATE ORDINARY 0.0 TABLET 27-11-18 FOR
TABLETS POLO GROUND TABLETS BLISTER,1.0 Non-Beta
INDORE X1000.0 Lactam: •
TABLET Tablets (coated
CONTAINER and uncoated)
35 NDA/MAL/H CYANO RENE PHARMACY DEXAMETHA DEXAMETH 0.5MG CYANO PHARMA(P)- INDIA ORAL SOLID 1.0X1000.0 7/1/2003 FAILED GMP ON NONE
DP/5072 PHARMA(P) LTD SONE ASONE 115-C IND ESTATE ORDINARY TABLET 27-11-18 FOR
TABLETS POLO GROUND TABLETS CONTAINER Non-Beta
INDORE Lactam: •
Tablets (coated
and uncoated)

36 NDA/MAL/H RENE RENE PHARMACY CODEINE CODEINE 30 MG CYANO PHARMA(P)- INDIA ORAL SOLID 1.0X100.0 7/1/1997 FAILED GMP ON NONE
DP/8124 PHARMACY(R) LTD PHOSPHATE PHOSPHATE 115-C IND ESTATE ORDINARY TABLET 27-11-18 FOR
LTD.. POLOGROUND, TABLETS BOTTLE Non-Beta
INDORE 452015 Lactam: •
Tablets (coated
and uncoated)

37 NDA/MAL/H ERIS LTD BENLE CONSULT RANI-DENK RANITIDINE 150MG DENK PHARMA GMBH GERMANY ORAL SOLID 1.0X20.0 7/1/2000 SUSPENDED DUE NONE
DP/2296 LIMITED 150 &CO.KG- ORDINARY TABLET TO IMPURITY
PRINZREGENTESTR.79. TABLETS BLISTER,1.0 FOUND IN API
81675 MUENCHEN, X10.0
GERMANY, GOLLSTR, TABLET
1-D-845529 BLISTER,1.0
X50.0
TABLET
38 NDA/MAL/H DR. KIM J.P.IMPEX SMOOTH C- MENTHOL 5MGS+0.12 DR KIM AYURVEDIC INDIA ORAL SOLID 1.0X100.0 RETENTION FEES NONE
HP/9086 AYURVEDIC PHARMACY (U) COOL CRYSTAL+CA MGS+0.15 PHARMACY-SHED NO. ORDINARY LOZENGE NOT PAID
PHARMACY LIMITED COUGH MPHOR+EU MGS+0.12 139, ADARSH ESTATE, LOZENGES CARTON
TABLETS CALYPTUS MGS NEAR CHAKUDIA
OIL+THYMO TEMPLE, RAKHIAL
L AHMEDABAD
GUJARAT - INDIA
39 NDA/MAL/H DROGSAN BUFFALO HEALTH CARDIOSAN AMLODIPIN 5 MG DROGSAN İLAÇLARI TURKEY ORAL SOLID 1.0X2.0X10. 29-11-17 RETENTION FEES NONE
DP/8601 İLAÇLARI SAN. CARE LTD 5MG E BESILATE SAN. VE TIC. A.Ş.- ORDINARY 0 TABLET NOT PAID
VE TIC. A.Ş. 06760 ÇUBUK TABLETS BLISTER
–ANKARA / TURKEY
40 NDA/MAL/H F.HOFFMANN- LABOREX DORMICUM MIDAZOLA 5MG/5ML F. HOFFMAN LA SWITZERLAN PARENTERAL 1.0X5.0 ML 7/1/2001 GMP EXPIRED NONE
DP/5276 LA ROCHE LTD UGANDA INJECTION M ROCHE LTD-CH-4070 D ORDINARY AMPOULE ON 24/11/2018
LIMITED BASEL AMPOULES FOR LINES
GRENZACHERSTRASSE Tablets Hard
124, 4058 BASEL Gelatin Capsules
SVP Solutions
Lyophilized Vial
Pre-filled
41 NDA/MAL/H ROCHE LABOREX DORMICUM MIDAZOLA 7.5MG F. HOFFMAN LA SWITZERLAN ORAL SOLID 1.0X10.0 7/1/1997 GMP EXPIRED NONE
DP/5278 UGANDA M ROCHE LTD-CH-4070 D ORDINARY TABLET ON 24/11/2018
LIMITED BASEL FILM- BLISTER FOR LINES
GRENZACHERSTRASSE COATED Tablets Hard
124, 4058 BASEL TABLETS Gelatin Capsules
SVP Solutions
Lyophilized Vial
Pre-filled
42 NDA/MAL/H F. HOFFMANN- LABOREX PEGASYS PEGINTERFE 180MCG/2 F.HOFFMANN- LA SWITZERLAN PARENTERAL 1.0X2.0 ML 7/1/2008 GMP EXPIRED NONE
DP/4562 LA ROCHE LTD UGANDA RON ALPHA ML ROCHE LTD-CH-4070 D ORDINARY I PRE- FILLED ON 24/11/2018
LIMITED 2A BASEL SWITZERLAND M PRE- SYRINGE FOR LINES
FILLED Tablets Hard
SYRINGES Gelatin Capsules
SVP Solutions
Lyophilized Vial
Pre-filled
43 NDA/MAL/H FOURRTS DELMAW L MONTUS LEVOCETIRI 5MG + FOURRTS (INDIA) INDIA ORAL SOLID 1.0X10.0 7/1/2015 FAILED GMP NONE
DP/0401 (INDIA) ENTERPRISES ZINE 10MG LABORATORIES (PVT) ORDINARY TABLET INSPECTION ON
LABORATORIES LIMITED HYDROCHL LTD-FOURRTS FILM- STRIP THE 17TH &
PVT LTD ORIDE + AVENUE, VANDALUR COATED 18TH June 2019
MONTELUK ROAD TABLETS for lines;
AST Tablets, Hard
SODIUM Gelatin Capsules,
Oral liquids,
44 NDA/MAL/H FOURRTS DELMAW K MAC ORAL POTASSIUM 22MG + FOURRTS INDIA INDIA ORAL LIQUID 1.0X200.0 7/1/2013 FAILED GMP NONE
DP/0432 (INDIA) ENTERPRISES SOLUTION CITRATE + 7.5MG LABORATORIES PVT. ORDINARY ML BOTTLE INSPECTION ON
LABORATORIES LIMITED MAGNESIU LIMITED-VANDALUR LIQUIDS THE 17TH &
PVT LTD M CITRATE ROAD, 18TH June 2019
KELAMBAKKAM for lines;
603103, CHENNAI, Tablets, Hard
TAMIL NADU, INDIA Gelatin Capsules,
Oral liquids,
45 NDA/MAL/H FOURRTS DELMAW FILDILOL CARVEDILOL 12.5 MG FOURRTS(INDIA) INDIA ORAL SOLID 1.0X3.0X10. 7/1/2014 FAILED GMP NONE
DP/0507 (INDIA) ENTERPRISES 12.5 LABORATORIES ORDINARY 0 TABLET INSPECTION ON
LABORATORIES LIMITED PVT.LIMITED- TABLETS BLISTER THE 17TH &
PVT LTD VANDALUR 18TH June 2019
ROAD,KELAMBAKKAM- for lines;
603 103, Tablets, Hard
TAMIL NADU,INDIA Gelatin Capsules,
Oral liquids,
46 NDA/MAL/H FOURRTS DELMAW FILDILOL 25 CARVEDILOL 25MG FOURRTS(INDIA) INDIA ORAL SOLID 1.0X3.0X10. 7/1/2015 FAILED GMP NONE
DP/0509 (INDIA) ENTERPRISES LABORATORIES ORDINARY 0 TABLET INSPECTION ON
LABORATORIES LIMITED PVT.LIMITED- TABLETS BLISTER THE 17TH &
(PVT) LTD VANDALUR 18TH June 2019
ROAD,KELAMBAKKAM- for lines;
603 103, Tablets, Hard
TAMIL NADU,INDIA Gelatin Capsules,
Oral liquids,
47 NDA/MAL/H FOURRTS(INDIA) DELMAW FILSTAT 10 ATORVASTA 10MG FOURRTS(INDIA) INDIA ORAL SOLID 1.0X3.0X10. 7/1/2014 FAILED GMP NONE
DP/0512 LABORATORIES ENTERPRISES TIN LABORATORIES ORDINARY 0 TABLET INSPECTION ON
PVT.LIMITED LIMITED CALCIUM PVT.LIMITED- TABLETS BLISTER THE 17TH &
VANDALUR 18TH June 2019
ROAD,KELAMBAKKAM- for lines;
603 103, Tablets, Hard
TAMIL NADU,INDIA Gelatin Capsules,
Oral liquids,
48 NDA/MAL/H FOURRTS(INDIA) DELMAW FILSTAT 20 ATORVASTA 20MG FOURRTS(INDIA) INDIA ORAL SOLID 1.0X3.0X10. 7/1/2014 FAILED GMP NONE
DP/0515 LABORATORIES ENTERPRISES TIN LABORATORIES ORDINARY 0 TABLET INSPECTION ON
PVT.LIMITED LIMITED PVT.LIMITED- TABLETS BLISTER THE 17TH &
VANDALUR 18TH June 2019
ROAD,KELAMBAKKAM- for lines;
603 103, Tablets, Hard
TAMIL NADU,INDIA Gelatin Capsules,
Oral liquids,
49 NDA/MAL/H FOURRTS(INDIA) DELMAW FILSTAT 40 ATORVASTA 40MG FOURRTS(INDIA) INDIA ORAL SOLID 1.0X10.0 7/1/2014 FAILED GMP NONE
DP/0520 LABORATORIES ENTERPRISES TIN LABORATORIES ORDINARY TABLET INSPECTION ON
PVT.LIMITED LIMITED CALCIUM PVT.LIMITED- TABLETS BLISTER THE 17TH &
VANDALUR 18TH June 2019
ROAD,KELAMBAKKAM- for lines;
603 103, Tablets, Hard
TAMIL NADU,INDIA Gelatin Capsules,
Oral liquids,
50 NDA/MAL/H FOURRTS(INDIA) DELMAW FOURTS B THIAMINE 10MG + FOURRTS INDIA INDIA ORAL SOLID 1.0X3.0X10. 7/1/2016 FAILED GMP NONE
DP/1337 LABORATORIES ENTERPRISES +RIBOFLAVI 10MG + LABORATORIES PVT. ORDINARY 0 CAPSULE INSPECTION ON
PVT.LIMITED LIMITED N+ 3MG + LIMITED-VANDALUR CAPSULES BLISTER THE 17TH &
PYRIDOXINE 50MG + ROAD, 18TH June 2019
+ 1MG + KELAMBAKKAM for lines;
NICOTINAM 75MG + 603103, CHENNAI, Tablets, Hard
IDE + FOLIC 400IU + TAMIL NADU, INDIA Gelatin Capsules,
ACID + 25MG Oral liquids,
51 NDA/MAL/H FOURRTS(INDIA) DELMAW SUCRAFIL O SUCRALFAT 10MG + FOURRTS INDIA INDIA ORAL LIQUID 1.0X100.0 7/1/2013 FAILED GMP NONE
DP/1456 LABORATORIES ENTERPRISES GEL E+ 0.2MG LABORATORIES PVT. ORDINARY ML INSPECTION ON
PVT.LIMITED LIMITED OXETACAIN LIMITED-VANDALUR SUSPENSION BOTTLE,1.0 THE 17TH &
E ROAD, S X200.0 ML 18TH June 2019
KELAMBAKKAM BOTTLE for lines;
603103, CHENNAI, Tablets, Hard
TAMIL NADU, INDIA Gelatin Capsules,
Oral liquids,
52 NDA/MAL/H FOURTS(INDIA) AIVEEN (U) FOMYCETIN CHLORAMP 250MG FOURRTS(INDIA) INDIA ORAL SOLID 1.0X1000.0 7/1/1997 FAILED GMP NONE
DP/1987 LABORATORIES LIMITED HENICOL LABORATORIES ORDINARY CAPSULE INSPECTION ON
PVT LTD PVT.LIMITED- CAPSULES CONTAINER THE 17TH &
VANDALUR ,1.0X10.0X1 18TH June 2019
ROAD,KELAMBAKKAM- 0.0 for lines;
603 103, CAPSULE Tablets, Hard
TAMIL NADU,INDIA BLISTER Gelatin Capsules,
Oral liquids,
53 NDA/MAL/H FOURTS(INDIA) SUPER MEDIC GRISEOFIL GRISEOFULV 500MG FOURRTS INDIA INDIA ORAL SOLID 1.0X10.0X1 7/1/2005 FAILED GMP NONE
DP/2143 LABORATORIES LTD IN LABORATORIES PVT. ORDINARY 0.0 TABLET INSPECTION ON
PVT LTD LIMITED-VANDALUR TABLETS BLISTER THE 17TH &
ROAD, 18TH June 2019
KELAMBAKKAM for lines;
603103, CHENNAI, Tablets, Hard
TAMIL NADU, INDIA Gelatin Capsules,
Oral liquids,
54 NDA/MAL/H FOURRTS DELMAW METFIL 500 METFORMI 500MG FOURRTS INDIA INDIA ORAL SOLID 1.0X500.0 7/1/2005 FAILED GMP NONE
DP/2145 (INDIA) ENTERPRISES N LABORATORIES PVT. ORDINARY TABLET INSPECTION ON
LABORATORIES LIMITED LIMITED-VANDALUR TABLETS CONTAINER THE 17TH &
PVT LTD ROAD, 18TH June 2019
KELAMBAKKAM for lines;
603103, CHENNAI, Tablets, Hard
TAMIL NADU, INDIA Gelatin Capsules,
Oral liquids,
55 NDA/MAL/H FOURRTS(INDIA) SUPER MEDIC DICLOFEN - DICLOFENA 50MG FOURRTS INDIA INDIA ORAL SOLID 1.0X10.0X1 7/1/2006 FAILED GMP NONE
DP/2147 LABORATORIES LTD 50 C LABORATORIES PVT. ORDINARY 0.0 TABLET INSPECTION ON
PVT.LIMITED LIMITED-VANDALUR ENTERIC- BLISTER THE 17TH &
ROAD, COATED 18TH June 2019
KELAMBAKKAM TABLETS for lines;
603103, CHENNAI, Tablets, Hard
TAMIL NADU, INDIA Gelatin Capsules,
Oral liquids,
56 NDA/MAL/H FOURTS(INDIA) SUPER MEDIC DOXEFIL DOXYCYCLI 100MG FOURRTS INDIA INDIA ORAL SOLID 1.0X10.0X1 7/1/2005 FAILED GMP NONE
DP/2155 LABORATORIES LTD NE LABORATORIES PVT. ORDINARY 0.0 INSPECTION ON
PVT LTD LIMITED-VANDALUR CAPSULES CAPSULE THE 17TH &
ROAD, BLISTER 18TH June 2019
KELAMBAKKAM for lines;
603103, CHENNAI, Tablets, Hard
TAMIL NADU, INDIA Gelatin Capsules,
Oral liquids,
57 NDA/MAL/H FOURTS(INDIA) SUPER MEDIC PARAFIL PARACETAM 500MG FOURRTS(INDIA) INDIA ORAL SOLID 1.0X500.0 7/1/1997 FAILED GMP NONE
DP/3476 LABORATORIES LTD OL LABORATORIES ORDINARY TABLET INSPECTION ON
PVT LTD PVT.LIMITED- TABLETS CONTAINER THE 17TH &
VANDALUR ,1.0X1000.0 18TH June 2019
ROAD,KELAMBAKKAM- TABLET for lines;
603 103, CONTAINER Tablets, Hard
TAMIL NADU,INDIA ,1.0X10.0X1 Gelatin Capsules,
0.0 TABLET Oral liquids,
58 NDA/MAL/H FOURRTS SUPER MEDIC MEGATRIM CO- 960 MG FOURRTS(INDIA) INDIA ORAL SOLID 1.0X3.0X10. 7/1/2008 FAILED GMP NONE
DP/3592 (INDIA) LTD DS TRIMOXAZO LABORATORIES ORDINARY 0 TABLET INSPECTION ON
LABORATORIES LE BP PVT.LIMITED- TABLETS BLISTER,1.0 THE 17TH &
PUT LTD VANDALUR X10.0X10.0 18TH June 2019
ROAD,KELAMBAKKAM- TABLET for lines;
603 103, BLISTER,1.0 Tablets, Hard
TAMIL NADU,INDIA X1000.0 Gelatin Capsules,
TABLET Oral liquids,
59 NDA/MAL/H FOURRTS DELMAW QUADRAJEL CHLORHEXI 5%W/W+1. FOURRTS(INDIA) INDIA ORAL 1.0X15.0 G 7/1/2008 FAILED GMP NONE
DP/3655 (INDIA) ENTERPRISES GEL DINE+METR 61%W/W+ LABORATORIES TOPICAL TUBE INSPECTION ON
LABORATORIES LIMITED ONIDAZOLE 2.13%W/W PVT.LIMITED- GELS AND THE 17TH &
PVT LTD +LIDOCAINE VANDALUR SOLS 18TH June 2019
ROAD,KELAMBAKKAM- for lines;
603 103, Tablets, Hard
TAMIL NADU,INDIA Gelatin Capsules,
Oral liquids,
60 NDA/MAL/H FOURRTS DELMAW REDINPLUS IRON 100MG + FOURRTS (INDIA) LABS INDIA ORAL SOLID 1.0X1.0X30. 7/1/2008 FAILED GMP NONE
DP/3678 LABORATORIES ENTERPRISES PENTACARB 30MG + PVT LTD .-VANDALUR ORDINARY 0 CAPSULE INSPECTION ON
LTD LIMITED ONYL + ZINC 7.5MG + ROAD. KELAMBAKK CAPSULES BLISTER THE 17TH &
SULPHATE 0.11MG + AM-603103 TAMIL, 18TH June 2019
MONOHYDR 26MG + INDIA for lines;
ATE + FOLIC 4.4MG + Tablets, Hard
ACID + 52MG Gelatin Capsules,
SODIUM Oral liquids,
61 NDA/MAL/H FOURRTS(INDIA) SUPER MEDIC MEBFIL MEBENDAZ 100MG FOURRTS(INDIA) INDIA ORAL SOLID 1.0X1000.0 7/1/1997 FAILED GMP NONE
DP/5033 LABORATORIES LTD TABLETS OLE LABORATORIES ORDINARY TABLET INSPECTION ON
PVT.LIMITED PVT.LIMITED- CHEWABLE CONTAINER THE 17TH &
VANDALUR TABLETS 18TH June 2019
ROAD,KELAMBAKKAM- for lines;
603 103, Tablets, Hard
TAMIL NADU,INDIA Gelatin Capsules,
Oral liquids,
62 NDA/MAL/H FOURTS(INDIA) AIVEEN (U) GLIFIL M GLIBENCLA 5MG+500 FOURRTS(INDIA) INDIA ORAL SOLID 1.0X10.0X1 7/1/2009 FAILED GMP NONE
DP/5086 LABORATORIES LIMITED FORT MIDE + MG LABORATORIES ORDINARY 0.0 TABLET INSPECTION ON
PVT LTD METFORMI PVT.LIMITED- TABLETS BLISTER THE 17TH &
N VANDALUR 18TH June 2019
HYDROCHL ROAD,KELAMBAKKAM- for lines;
ORIDE 603 103, Tablets, Hard
TAMIL NADU,INDIA Gelatin Capsules,
Oral liquids,
63 NDA/MAL/H FOURRTS(INDIA) DELMAW KONTRAC MISOPROST 200MCG FOURRTS INDIA INDIA ORAL SOLID 1.0X1.0X2.0 7/1/2009 FAILED GMP NONE
DP/5119 LABORATORIES ENTERPRISES 200 OL LABORATORIES PVT. ORDINARY TABLET INSPECTION ON
PVT.LIMITED LIMITED LIMITED-VANDALUR TABLETS STRIP,1.0X1 THE 17TH &
ROAD, 0.0X10.0 18TH June 2019
KELAMBAKKAM TABLET for lines;
603103, CHENNAI, BLISTER Tablets, Hard
TAMIL NADU, INDIA Gelatin Capsules,
Oral liquids,
64 NDA/MAL/H FOURRTS(INDIA) AIVEEN (U) IBUFIL 400 IBUPROFEN 400MG FOURRTS(INDIA) INDIA ORAL SOLID 1.0X10.0X1 7/1/1998 FAILED GMP NONE
DP/5324 LABORATORIES LIMITED LABORATORIES ORDINARY 0.0 TABLET INSPECTION ON
PVT.LIMITED PVT.LIMITED- FILM- BLISTER,1.0 THE 17TH &
VANDALUR COATED X1000.0 18TH June 2019
ROAD,KELAMBAKKAM- TABLETS TABLET for lines;
603 103, CONTAINER Tablets, Hard
TAMIL NADU,INDIA Gelatin Capsules,
Oral liquids,
65 NDA/MAL/H FOURRTS(INDIA) AIVEEN (U) IBUFIL 200 IBUPROFEN 200MG FOURRTS(INDIA) INDIA ORAL SOLID 1.0X10.0X1 7/1/1997 FAILED GMP NONE
DP/5327 LABORATORIES LIMITED LABORATORIES ORDINARY 0.0 TABLET INSPECTION ON
PVT.LIMITED PVT.LIMITED- FILM- BLISTER,1.0 THE 17TH &
VANDALUR COATED X1000.0 18TH June 2019
ROAD,KELAMBAKKAM- TABLETS TABLET for lines;
603 103, CONTAINER Tablets, Hard
TAMIL NADU,INDIA Gelatin Capsules,
Oral liquids,
66 NDA/MAL/H FOURTS(INDIA) SUPER MEDIC FINAZOL ALBENDAZO 400MG FOURRTS(INDIA) INDIA ORAL SOLID 1.0X500.0 7/1/2007 FAILED GMP NONE
DP/5394 LABORATORIES LTD LE LABORATORIES ORDINARY TABLET INSPECTION ON
PVT LTD PVT.LIMITED- TABLETS CONTAINER THE 17TH &
VANDALUR ,1.0X1000.0 18TH June 2019
ROAD,KELAMBAKKAM- TABLET for lines;
603 103, CONTAINER Tablets, Hard
TAMIL NADU,INDIA Gelatin Capsules,
Oral liquids,
67 NDA/MAL/H FOURRTS(INDIA) SUPER MEDIC CIPFIL 500 CIPROFLOXA 500MG FOURRTS(INDIA) INDIA ORAL SOLID 1.0X10.0X1 7/1/2007 FAILED GMP NONE
DP/5428 LABORATORIES LTD CIN LABORATORIES ORDINARY 0.0 TABLET INSPECTION ON
PVT.LIMITED PVT.LIMITED- FILM- BLISTER THE 17TH &
VANDALUR COATED 18TH June 2019
ROAD,KELAMBAKKAM- TABLETS for lines;
603 103, Tablets, Hard
TAMIL NADU,INDIA Gelatin Capsules,
Oral liquids,
68 NDA/MAL/H FOURTS(INDIA) SUPER MEDIC MEGATRIM CO- 240MG/5M FOURTS (INDIA) INDIA ORAL LIQUID 1.0X60.0 7/1/1997 FAILED GMP NONE
DP/1651 LABORATORIES LTD SUSPENSION TRIMOXAZO L LABORATORIES ORDINARY ML INSPECTION ON
PVT LTD LE PRIVATE LIMITED - DRY BOTTLE,1.0 THE 17TH &
VANDALUR ROAD SUSPENSION X100.0 ML 18TH June 2019
S/SYRUPS/DR BOTTLE for lines;
OPS Tablets, Hard
Gelatin Capsules,
Oral liquids,
69 NDA/MAL/H FOURTS(INDIA) AIVEEN (U) PROFIL 25 PROMETHA 25MG FOURTS (INDIA) INDIA ORAL SOLID 1.0X1000.0 7/1/1997 FAILED GMP NONE
DP/2492 LABORATORIES LIMITED ZINE LABORATORIES ORDINARY TABLET INSPECTION ON
PVT LTD HYDROCHL PRIVATE LIMITED - TABLETS CONTAINER THE 17TH &
ORIDE VANDALUR ROAD 18TH June 2019
for lines;
Tablets, Hard
Gelatin Capsules,
Oral liquids,
70 NDA/MAL/H FOURTS(INDIA) AIVEEN (U) FUNGIFEN CLOTRIMAZ 1%W/W FOURTS (INDIA) INDIA TOPICAL 1.0X15.0 G 7/1/1997 FAILED GMP NONE
DP/2661 LABORATORIES LIMITED OLE LABORATORIES EXTERNAL TUBE INSPECTION ON
PVT LTD PRIVATE LIMITED - CREAMS THE 17TH &
VANDALUR ROAD 18TH June 2019
for lines;
Tablets, Hard
Gelatin Capsules,
Oral liquids,
71 NDA/MAL/H FOURTS(INDIA) DELMAW IDUMSTRA PARACETAM 325MG + FOURTS (INDIA) INDIA ORAL SOLID 1.0X20.0X1 7/1/2009 FAILED GMP NONE
DP/2695 LABORATORIES ENTERPRISES OL + 200MG + LABORATORIES ORDINARY 0.0 INSPECTION ON
PVT LTD LIMITED IBUPROFEN 40MG PRIVATE LIMITED - CAPSULES CAPSULE THE 17TH &
+ CAFFEINE VANDALUR ROAD BLISTER 18TH June 2019
for lines;
Tablets, Hard
Gelatin Capsules,
Oral liquids,
72 NDA/MAL/H FOURTS(INDIA) AIVEEN (U) GRAMOFIL NALIDIXIC 500MG FOURTS (INDIA) INDIA ORAL SOLID 1.0X1000.0 7/1/1997 FAILED GMP NONE
DP/2837 LABORATORIES LIMITED TABLETS ACID LABORATORIES ORDINARY TABLET INSPECTION ON
PVT LTD PRIVATE LIMITED - TABLETS CONTAINER THE 17TH &
VANDALUR ROAD ,1.0X10.0X1 18TH June 2019
0.0 TABLET for lines;
BLISTER Tablets, Hard
Gelatin Capsules,
Oral liquids,
73 NDA/MAL/H FOURTS(INDIA) DELMAW COLD TABS PARACETAM 500MG + FOURTS (INDIA) INDIA ORAL SOLID 1.0X4.0X25. 7/1/2013 FAILED GMP NONE
DP/3683 LABORATORIES ENTERPRISES FORTINSA OL + 5MG + LABORATORIES ORDINARY 0 TABLET INSPECTION ON
PVT LTD LIMITED PHENYLEPH 2MG + PRIVATE LIMITED - TABLETS BLISTER THE 17TH &
RINE 30MG VANDALUR ROAD 18TH June 2019
+CHLORPHE for lines;
NIRAMINE + Tablets, Hard
CAFFEINE Gelatin Capsules,
Oral liquids,
74 NDA/MAL/H FOURTS(INDIA) SUPER MEDIC MEGATRIM CO- 480MG FOURTS (INDIA) INDIA ORAL SOLID 1.0X10.0X1 7/1/1997 FAILED GMP NONE
DP/3841 LABORATORIES LTD TABLETS TRIMOXAZO LABORATORIES ORDINARY 0.0 TABLET INSPECTION ON
PVT LTD LE PRIVATE LIMITED - TABLETS BLISTER,1.0 THE 17TH &
VANDALUR ROAD X1000.0 18TH June 2019
TABLET for lines;
CONTAINER Tablets, Hard
Gelatin Capsules,
Oral liquids,
75 NDA/MAL/H FOURTS(INDIA) AIVEEN (U) GEFIL COMPOUND ALUMINIU FOURTS (INDIA) CHINA ORAL SOLID 1.0X1000.0 7/1/2005 FAILED GMP NONE
DP/4399 LABORATORIES LIMITED MAGNESIU M LABORATORIES ORDINARY TABLET INSPECTION ON
PVT LTD M HYDROXID PRIVATE LIMITED - TABLETS CONTAINER THE 17TH &
TRISILICATE
E& VANDALUR ROAD 18TH June 2019
MAGNESIU for lines;
M Tablets, Hard
TRISILICATE Gelatin Capsules,
132 & Oral liquids,
76 NDA/MAL/H FOURTS(INDIA) SUPER MEDIC FOGYL-S METRONIDA 200MG FOURTS (INDIA) INDIA ORAL SOLID 1.0X1000.0 7/1/1997 FAILED GMP NONE
DP/4915 LABORATORIES LTD TABLETS ZOLE LABORATORIES ORDINARY TABLET INSPECTION ON
PVT LTD PRIVATE LIMITED - TABLETS CONTAINER THE 17TH &
VANDALUR ROAD 18TH June 2019
for lines;
Tablets, Hard
Gelatin Capsules,
Oral liquids,
77 NDA/MAL/H FOURTS(INDIA) SUPER MEDIC FOGYL METRONIDA 200MG/5M FOURTS (INDIA) INDIA ORAL LIQUID 1.0X100.0 7/1/1997 FAILED GMP NONE
DP/4918 LABORATORIES LTD SUSPENSION ZOLE L LABORATORIES ORDINARY ML BOTTLE INSPECTION ON
PVT LTD BENZOATE PRIVATE LIMITED - SUSPENSION THE 17TH &
VANDALUR ROAD S 18TH June 2019
for lines;
Tablets, Hard
Gelatin Capsules,
Oral liquids,
78 NDA/MAL/H FRESENIUS KABI SURGIPHARM (U) KETAMINE KETAMINE 50MG/ML FRESENIUS KABI SOUTH PARENTERAL 1.0X10.0X1 7/1/2014 GMP EXPIRED NONE
DP/0382 MANUFACTURI LIMITED FRESENIUS HYDROCHL MANUFACTURING SA AFRICA ORDINARY 0.0 ML VIAL ON 2016-12-06
NG S.A (PTY) ORIDE (PTY) LTD-6 GIBAUD VIALS FOR NBL •Small
LTD ROAD, KORSTEN 6020, Volume
PORT ELIZABETH Parenteral
solutions packed
in ampoules and
vials (non-
79 NDA/MAL/H FRESENIUS KABI SURGIPHARM (U) MANNITOL MANNITOL 20%W/V FRESENIUS KABI SOUTH PARENTERAL 1.0X500.0 7/1/2014 GMP EXPIRED NONE
DP/0383 MANUFACTURI LIMITED FRESENIUS MANUFACTURING SA AFRICA ORDINARY ML BAG ON 2016-12-06
NG S.A (PTY) (PTY) LTD-6 GIBAUD INFUSION FOR NBL •Small
LTD ROAD, KORSTEN 6020, BAGS Volume
PORT ELIZABETH Parenteral
solutions packed
in ampoules and
vials (non-
80 NDA/MAL/H FRESENIUS KABI SURGIPHARM (U) PANCURONI PANCURONI 4MG/2ML FRESENIUS KABI SOUTH PARENTERAL 1.0X10.0X2. 7/1/2014 GMP EXPIRED NONE
DP/0384 MANUFACTURI LIMITED UM UM MANUFACTURING SA AFRICA ORDINARY 0 ML ON 2016-12-06
NG S.A (PTY) BROMIDE BROMIDE (PTY) LTD-6 GIBAUD AMPOULES AMPOULE FOR NBL •Small
LTD FRESENIUS ROAD, KORSTEN 6020, Volume
PORT ELIZABETH Parenteral
solutions packed
in ampoules and
vials (non-
81 NDA/MAL/H FRESENIUS KABI SURGIPHARM (U) LIGNOCAINE LIGNOCAINE 2%W/V FRESENIUS KABI SOUTH PARENTERAL 1.0X10.0X2 7/1/2015 GMP EXPIRED NONE
DP/0435 MANUFACTURI LIMITED HCL HYDROCHL MANUFACTURING SA AFRICA ORDINARY 0.0 ML VIAL ON 2016-12-06
NG S.A (PTY) FRESENIUS ORIDE (PTY) LTD-6 GIBAUD VIALS FOR NBL •Small
LTD ROAD, KORSTEN 6020, Volume
PORT ELIZABETH Parenteral
solutions packed
in ampoules and
vials (non-
82 NDA/MAL/H FRESENIUS KABI SURGIPHARM (U) NALOXONE NALOXONE 0.02MG/M FRESENIUS KABI SOUTH PARENTERAL 1.0X10.0X2. 7/1/2014 GMP EXPIRED NONE
DP/0437 SOUTH AFRICA LIMITED HCL HYDROCHL L MANUFACTURING SA AFRICA ORDINARY 0 ML ON 2016-12-06
(PTY) LIMITED NEONATAL ORIDE (PTY) LTD-6 GIBAUD AMPOULES AMPOULE FOR NBL •Small
FRESENIUS ROAD, KORSTEN 6020, Volume
PORT ELIZABETH Parenteral
solutions packed
in ampoules and
vials (non-
83 NDA/MAL/H FRESENIUS KABI SURGIPHARM (U) NALOXONE NALOXONE 0.4MG/1M FRESENIUS KABI SOUTH PARENTERAL 1.0X10.0X1. 7/1/2015 GMP EXPIRED NONE
DP/0439 SOUTH AFRICA LIMITED HCL HYDROCHL L MANUFACTURING SA AFRICA ORDINARY 0 ML ON 2016-12-06
(PTY) LIMITED FRESENIUS ORIDE (PTY) LTD-6 GIBAUD AMPOULES AMPOULE FOR NBL •Small
0.4MG/1ML ROAD, KORSTEN 6020, Volume
PORT ELIZABETH Parenteral
solutions packed
in ampoules and
vials (non-
84 NDA/MAL/H FRESENIUS KABI SURGIPHARM (U) NEOSTIGMIN NEOSTIGMI 2.5MG\ML FRESENIUS KABI SOUTH PARENTERAL 1.0X10.0X1. 7/1/2015 GMP EXPIRED NONE
DP/0444 MANUFACTURI LIMITED E NE MANUFACTURING SA AFRICA ORDINARY 0 ML ON 2016-12-06
NG S.A (PTY) METHYLSUIP METHYLSUL (PTY) LTD-6 GIBAUD AMPOULES AMPOULE FOR NBL •Small
LTD HATE PHATE ROAD, KORSTEN 6020, Volume
FRESENIUS PORT ELIZABETH Parenteral
solutions packed
in ampoules and
vials (non-
85 NDA/MAL/H FRESENIUS KABI SURGIPHARM (U) SUXAMETHO SUXAMETH 100MG/2M FRESENIUS KABI SOUTH PARENTERAL 1.0X10.0X2. 7/1/2016 GMP EXPIRED NONE
DP/4407 MANUFACTURI LIMITED NIUM ONIUM L MANUFACTURING S.A AFRICA ORDINARY 0 ML ON 2016-12-06
NG S.A (PTY) CHLORIDE- CHLORIDE (PTY) LTD √-6 AMPOULES AMPOULE FOR NBL •Small
LTD FRESENIUS GIBAUD…ROAD Volume
KORSTEN, PORT Parenteral
ELIZABETH, SOUTH solutions packed
AFRICA. in ampoules and
vials (non-
86 NDA/MAL/H FRESENIUS KABI SURGIPHARM (U) FENTANYL FENTANYL 100MCG/2 FRESENIUS KABI SOUTH PARENTERAL 1.0X10.0X2. 7/1/2017 GMP EXPIRED NONE
DP/6058 MANUFACTURI LIMITED FRESENIUS ML MANUFACTURING SA AFRICA ORDINARY 0 ML ON 2016-12-06
NG S.A (PTY) 100MCG/2M (PTY) LTD-6 GIBAUD AMPOULES AMPOULE FOR NBL •Small
LTD L ROAD, KORSTEN 6020, Volume
PORT ELIZABETH Parenteral
solutions packed
in ampoules and
vials (non-
87 NDA/MAL/H FRESENIUS KABI SURGIPHARM (U) FENTANYL FENTANYL 500MCG/1 FRESENIUS KABI SOUTH PARENTERAL 1.0X5.0X10. 7/1/2016 GMP EXPIRED NONE
DP/6194 MANUFACTURI LIMITED FRESENIUS CITRATE 0ML MANUFACTURING SA AFRICA ORDINARY 0 ML ON 2016-12-06
NG S.A (PTY) 500MCG/10 (PTY) LTD-6 GIBAUD AMPOULES AMPOULE FOR NBL •Small
LTD ML ROAD, KORSTEN 6020, Volume
PORT ELIZABETH Parenteral
solutions packed
in ampoules and
vials (non-
88 NDA/MAL/H FRESENIUS KABI SURGIPHARM (U) MORPHINE MORPHINE 10MG/ML FRESENIUS KABI SOUTH PARENTERAL 1.0X10.0X1. 7/1/2016 GMP EXPIRED NONE
DP/6195 MANUFACTURI LIMITED SULPHATE SULPHATE MANUFACTURING SA AFRICA ORDINARY 0 ML ON 2016-12-06
NG S.A (PTY) FRESENIUS (PTY) LTD-6 GIBAUD AMPOULES AMPOULE FOR NBL •Small
LTD ROAD, KORSTEN 6020, Volume
PORT ELIZABETH Parenteral
solutions packed
in ampoules and
vials (non-
89 NDA/MAL/H FRESENIUS KABI SURGIPHARM (U) MORPHINE MORPHINE 15MG/ML FRESENIUS KABI SOUTH PARENTERAL 1.0X10.0X1. 7/1/2016 GMP EXPIRED NONE
DP/6196 MANUFACTURI LIMITED SULPHATE SULPHATE MANUFACTURING SA AFRICA ORDINARY 0 ML ON 2016-12-06
NG S.A (PTY) FRESENIUS (PTY) LTD-6 GIBAUD AMPOULES AMPOULE FOR NBL •Small
LTD ROAD, KORSTEN 6020, Volume
PORT ELIZABETH Parenteral
solutions packed
in ampoules and
vials (non-
90 NDA/MAL/H WIN-MEDICARE SURGIPHARM (U) DICLOMOL DICLOFENA 1.16%W/W G,S PHARMBUTOR INDIA TOPICAL 1.0X20.0 G 7/1/2015 FAILED GMP ON NONE
DP/4706 PVT LTD LIMITED GEL C PVT LTD -B-172 EXTERNAL CONTAINER THE 27TH-
DIETHYLAMI INDUSTRIAL AREA GELS AND 28TH/06/2019
NE BEHROR 301701 SOLS FOR LINES;
RAJASTHAN Liquids for
internal use,
liquids for
external use, Dry
91 NDA/MAL/H MODI MUNDI SURGIPHARM (U) BETADINE POVIDONE- 7.5%W/W G,S PHARMBUTOR INDIA TOPICAL 1.0X1.0X50. 9/26/2018 FAILED GMP ON NONE
DP/8163 PHARMA PVT LIMITED SURGICAL IODINE PVT LTD -B-172 EXTERNAL 0 ML THE 27TH-
LTD SCRUB INDUSTRIAL AREA LIQUIDS BOTTLE,1.0 28TH/06/2019
BEHROR 301701 X500.0 ML FOR LINES;
RAJASTHAN BOTTLE Liquids for
internal use,
liquids for
external use, Dry
92 NDA/MAL/H MODI MUNDI SURGIPHARM (U) BETADINE POVIDONE- 10%W/W G,S PHARMBUTOR INDIA TOPICAL 1.0X1.0X50. 9/26/2018 FAILED GMP ON NONE
DP/8167 PHARMA PVT LIMITED STANDARDIS IODINE PVT LTD -B-172 EXTERNAL 0 ML THE 27TH-
LTD ED INDUSTRIAL AREA LIQUIDS BOTTLE,1.0 28TH/06/2019
MICROBICID BEHROR 301701 X1.0X100.0 FOR LINES;
AL SOLUTION RAJASTHAN ML Liquids for
10% W/V BOTTLE,1.0 internal use,
X500.0 ML liquids for
BOTTLE external use, Dry
93 NDA/MAL/H WIN-MEDICARE SURGIPHARM (U) OSMOWIN LACTULOSE 10G/15ML G.S PHAMBUTOR PVT INDIA ORAL LIQUID 1.0X100.0 7/1/2015 FAILED GMP ON NONE
DP/4180 PVT LTD LIMITED LTD-G.S PHAMBUTOR ORDINARY ML THE 27TH-
PVT LTD B-172 RIICO SYRUPS BOTTLE,1.0 28TH/06/2019
IND ,BEHOR 301701 X200.0 ML FOR LINES;
DIST ALWAR BOTTLE Liquids for
RAJASTHAN INDIA internal use,
liquids for
external use, Dry
94 NDA/MAL/H MODI MUNDI SURGIPHARM (U) BETADINE POVIDONE 5%W/W G.S PHAMBUTOR PVT INDIA TOPICAL 1.0X15.0 G 7/1/2017 FAILED GMP ON NONE
DP/7312 PHARMA PVT LIMITED OINTMENT IODINE LTD .-B-172 RIICO IND EXTERNAL TUBE,1.0X1 THE 27TH-
LTD 5%W/W ,BEHOR 301701 DIST OINTMENTS 25.0 G 28TH/06/2019
ALWAR RAJASTHAN TUBE,1.0X2 FOR LINES;
INDIA 50.0 G JAR Liquids for
internal use,
liquids for
external use, Dry
95 NDA/MAL/H MODI MUNDI SURGIPHARM (U) BETADINE POVIDONE 5%W/V G.S PHAMBUTOR PVT INDIA TOPICAL 1.0X100.0 7/1/2017 FAILED GMP ON NONE
DP/7335 PHARMA PVT LIMITED 5% IODINE LTD .-B-172 RIICO IND EXTERNAL ML THE 27TH-
LTD ,BEHOR 301701 DIST LIQUIDS BOTTLE,1.0 28TH/06/2019
ALWAR RAJASTHAN X500.0 ML FOR LINES;
INDIA BOTTLE,1.0 Liquids for
X50.0 ML internal use,
BOTTLE liquids for
external use, Dry
96 NDA/MAL/H MODI SURGIPHARM (U) BETADINE POVIDONE 2%W/V G.S PHAMBUTOR PVT INDIA ORAL 1.0X50.0 1/31/2018 FAILED GMP ON NONE
DP/7336 NUNDIPHARMA LIMITED GERMICIDE IODINE LTD-G.S PHAMBUTOR TOPICAL ML THE 27TH-
PVT LTD GARGLE 2% PVT LTD B-172 RIICO LIQUIDS BOTTLE,1.0 28TH/06/2019
MINT IND ,BEHOR 301701 X100.0 ML FOR LINES;
DIST ALWAR BOTTLE Liquids for
RAJASTHAN INDIA internal use,
liquids for
external use, Dry
97 NDA/MAL/H MODI MUNDI SURGIPHARM (U) BETADINE POVIDONE- 5%W/W G.S PHAMBUTOR PVT INDIA TOPICAL 1.0X10.0 G 7/1/2017 FAILED GMP ON NONE
DP/7381 PHARMA PVT LIMITED ANTISEPTIC IODINE LTD .-B-172 RIICO IND EXTERNAL TUBE,1.0X2 THE 27TH-
LTD CREAM 5% ,BEHOR 301701 DIST CREAMS 0.0 G TUBE 28TH/06/2019
ALWAR RAJASTHAN FOR LINES;
INDIA Liquids for
internal use,
liquids for
external use, Dry
98 NDA/MAL/H GLAXO UNITED ZANTAC RANITIDINE 50MG/2ML GLAXO SMITHKLINE ITALY PARENTERAL 1.0X2.0 ML 7/1/1997 SUSPENDED DUE NONE
DP/0903 WELLCOME(KEN HEALTHCARE MANUFACTURING ORDINARY AMPOULE TO IMPURITY
YA) LTD DISTRIBUTORS S.P.A .-STARDA AMPOULES FOUND IN API
LTD PROVINCIALE
ASOLANA 90, 43056
SAN POLO DI TORRILE
(PARMA)
99 NDA/MAL/H GLAXO UNITED ZANTAC RANITIDINE 150MG GLAXOSMITHKLINE KENYA ORAL SOLID 1.0X20.0 7/1/1997 SUSPENDED DUE NONE
DP/3885 WELLCOME(KEN HEALTHCARE LIMITED - -78392- ORDINARY TABLET TO IMPURITY
YA) LTD DISTRIBUTORS 00507, VIWANDANI FILM- BLISTER,1.0 FOUND IN API
LTD LIKONI ROAD COATED X30.0
NAIROBI KENYA TABLETS TABLET
BLISTER,1.0
X10.0
TABLET
100 NDA/MAL/H H.HOFFMAN LABOREX BONVIVA IBANDRONI 150MG H. HOFFMAN ROCHE- SWITZERLAN ORAL SOLID 1.0X1.0 7/1/2008 GMP EXPIRED F. HOFFMANN
DP/5355 ROCHE UGANDA C ACID GRENZACHERSTRASE D ORDINARY TABLET ON 24/11/2018 LA-ROCHE-
LIMITED 124, EXT 4070, BASEL FILM- BLISTER FOR LINES WURMISWEG
SWITZERLAND COATED Tablets Hard CH-4303
TABLETS Gelatin Capsules KAISERAUGST
SVP Solutions
Lyophilized Vial
Pre-filled
101 NDA/MAL/H NAARI AG BASEL ECHO MIFETRIL MIFEPRISTO 200MG JAGSONPAL INDIA ORAL SOLID 1.0X10.0X3. 7/1/2013 GMP EXPIRED NONE
DP/4893 PHARMACY (U) NE PHARMACEUTICALS ORDINARY 0 TABLET ON 2018-10-13
LIMITED LTD-PLOT NO.14- TABLETS BLISTER FOR Non Beta
16,55-57,SECTOR-5,IIE
PANT General tablets
NAGAR,SIDCUL,RUDR (coated and un
APUR UDHAM SINGH
NAGAR,UTTARAKHAN gelatin Capsules
102 NDA/MAL/H NAARI PTE ECHO ASEMOL SALBUTAM 100 MCG JEWIM CHINA LUNG 1.0X1.0X20 11/7/2018 GMP EXPIRED NONE
DP/7273 PHARMACY (U) OL SULFATE PER DOSE PHARMACEUTICALS ADMINISTRA 0.0 DOSE ON 20-05-19
LIMITED (SHANDONG) CO.,LTD - TION CANNISTER FOR NBL Sprays
-EAST PLANT NO.49 METERED- Aerosols
MIDDLE OF DOSE
CHUANGYE MAIN POWDER
STREET, TAIAN HIGH- INHALER
TECH
103 NDA/MAL/H KAMPALA KAMPALA CEFTONE CEFTRIAXO 1G KAMPALA UGANDA PARENTERAL 1.0X1.0 G 7/1/2009 RETENTION FEES NONE
DP/8080 PHARMACEUTIC PHARMACEUTICA NE PHARMACEUTICAL ORDINARY VIAL + NOT PAID
AL INDUSTRIES L INDUSTRIES INDUSTRIES (1996) DRY VIALS 1*10 ML
(1996) LTD 1996 LIMITED LIMITED - -STRETCHER WATER FOR
ROAD PLOT M444B INJECTION
NTINDA KAMPALA

104 NDA/MAL/H KAMPALA KAMPALA CIPROL-500 CIPROFLOXA 500MG KAMPALA UGANDA ORAL SOLID 1.0X10.0X1 7/1/2007 RETENTION FEES NONE
DP/8085 PHARMACEUTIC PHARMACEUTICA CIN PHARMACEUTICAL ORDINARY 0.0 TABLET NOT PAID
AL INDUSTRIES L INDUSTRIES INDUSTRIES (1996) TABLETS BLISTER
(1996) LTD 1996 LIMITED LTD -PLOT NO.
M444B, STRETCHER
ROAD, NTINDA,
KAMPALA
105 NDA/MAL/H ACINO PHARMA GOODMAN COAMOX- AMOXICILLI 875MG + LEK SLOVENIA ORAL SOLID 1.0X2.0X6.0 7/1/2006 GMP EXPIRED NONE
DP/8172 AG INTERNATIONAL ACINO 1000 N + 125 MG PHARMACEUTICALS- ORDINARY TABLET ON 17-02-2020
LTD CLAVULANI PREVALJE SITE, TABLETS BLISTER FOR B-
C ACID PERZONALI 47, S1- LACTAM(PENICIL
2391, PREVALJE LINS):TABLETS
AND POWDERS
FOR ORAL
SUSPENSION
106 NDA/MAL/H ELI-LILLY LABOREX HUMULIN HUMAN 70/30 I.U LILLY EGYPT S.A.E. & UNITED PARENTERAL 1.0X4.0 ML 7/1/1999 GMP EXPIRED ELI LILLY AND
DP/2150 (SUISSE) SA UGANDA MIXTURE INSULIN STATES ORDINARY S VIAL,1.0X10 ON 2017-03-24 COMPANY LILLY
LIMITED C VIALS .0 ML FOR SVP TECHNOLOGY
VIAL,1.0X5. Solutions - CENTRE
0X3.0 ML Insulin INDIANAPOLIS,-
CARTRIDGE INDIANA 46285
USA
107 NDA/MAL/H ELI-LILLY LABOREX HUMULIN N HUMAN 100IU LILLY EGYPT S.A.E. & EGYPT PARENTERAL 1.0X10.0 7/1/2005 GMP EXPIRED ELI LILLY AND
DP/3772 (SUISSE) SA UGANDA NPH INSULIN ORDINARY S ML ON 2017-03-24 COMPANY LILLY
LIMITED ISOPHANE C VIALS VIAL,1.0X5. FOR SVP TECHNOLOGY
0X3.0 ML Solutions - CENTRE
CARTRIDGE Insulin INDIANAPOLIS,-
INDIANA 46285
USA
108 NDA/MAL/H ABACUS ABACUS TOPCID-150 RANITIDINE 150MG LINCOLN INDIA ORAL SOLID 1.0X10.0X1 7/1/2013 SUSPENDED DUE NONE
DP/0223 PHARMA LTD PARENTERAL PHARMACEUTICALS ORDINARY 0.0 TABLET TO IMPURITY
DRUGS LIMITED LTD .-10,12,13 TABLETS STRIP FOUND IN API
TRIMUL ESTATE, NEAR
KHATRAJ CHOKADI,
P.O. KHATRAJ-382721
TA: KALOL, DIST.
GANDHINAGAR,
109 NDA/MAL/H KORLYNS MEDICATRIX (U) PROSTAN ED LATANOPRO 0.005%W/ LUNAN BETTER CHINA OPHTHALMI 1.0X6.0X2.5 7/1/2017 GMP EXPIRED NONE
DP/8255 THERAPEUTICS LTD ST V PHARMACEUTICAL C DROPS ML BOTTLE ON 31-05-19
LTD CO., LTD.-NO.209, FOR Latanoprost
HONGQI AVENUE, eye drops (NBL)
LANSHAN DISTRICT Oral coated
LINYI, SHANDONG, tablets
276006 CHINA (penicillin)
+86-5398331258 †
110 NDA/MAL/H MEDIPHARM MEDIPHARM ORALYTE CO- DT ZINC-20 20G MEDICAMEN BIOTECH INDIA ORAL LIQUID 1.0X2.0X20. 7/1/2016 RETENTION FEES NONE
DP/1369 (EA) LTD INDUSTRIES (E.A) PACK + ORAL LTD,.-SP-1192 A&B ORDINARY 8 G SACHET NOT PAID
LTD ORANGE REHYDRATI PHASE IV INDUSTRIAL SOLUBLE + 1.0 *10.0
FLAVOUR ON SALTS AREA BHIWADI POWDERS TABLET
(ORS) 301019 DIST. ALWAR BLISTER
(RAJASTHAN) - INDIA
MEDIPHARM
INDUSTRIES( EA) LTD-
111 NDA/MAL/H MYLAN KIMSY MEDS LTD CEF2 250 CEFUROXIM 250MG MEDREICH LIMITED INDIA ORAL SOLID 1.0X10.0 7/1/2013 GMP EXPIRED NONE
DP/0146 PHARMACEUTIC E AXETIL UNIT-5-PLOT 45 A & ORDINARY TABLET ON 14/06/2019
AL PRIVATE B, ANRICH FILM- BLISTER FOR
LIMITED, INDIA INDUSTRIAL ESTATE, COATED CEPHALOSPORIN
BOLLARAM, MEDAK TABLETS LINE
DISTRICT, 502 325,
TELANGANA INDIA
112 NDA/MAL/H MYLAN KIMSY MEDS LTD CEF 2 500 CEFUROXIM 500MG MEDREICH LIMITED INDIA ORAL SOLID 1.0X10.0 7/1/2013 GMP EXPIRED NONE
DP/0147 PHARMACEUTIC E AXETIL UNIT-5-PLOT 45 A & ORDINARY TABLET ON 14/06/2019
AL PRIVATE B, ANRICH FILM- BLISTER FOR
LIMITED, INDIA INDUSTRIAL ESTATE, COATED CEPHALOSPORIN
BOLLARAM, MEDAK TABLETS LINE
DISTRICT, 502 325,
TELANGANA INDIA
113 NDA/MAL/H MEDREICH PLC LABOREX AMEDIN-5 AMLODIPIN 5 MG MEDREICH LTD.-49 INDIA ORAL SOLID 1.0X14.0X2. 7/1/2006 GMP EXPIRED MEDREICH
DP/2106 UGANDA E (B&C) ORDINARY 0 TABLET ON 29/11/2010 LIMITED-UNIT 3-
LIMITED BOMMASANDRA TABLETS BLISTER FOR NBL Tablets SURVEY NO.4/3,
INDUSTRIAL AREA, Hard Gelatin AVALAHALLI,
ANNEKAL TALUK Capsules ANJANAPURA,
BANGALORE 560 099 OFF
INDIA KANAKAPURA
ROAD,
114 NDA/MAL/H MEDREICH LTD LABOREX OMIZEC OMEPRAZO 20MG MEDREICH STERILAB INDIA ORAL SOLID 1.0X4.0X7.0 7/1/2010 GMP EXPIRED NONE
DP/3133 UGANDA LE LTD.- ORDINARY CAPSULE ON 29/11/2010
LIMITED 49(B&C)BOMMASAND ENTERIC- BLISTER FOR NBL Tablets
RA IND. AREA COATED Hard Gelatin
ANEKOL, CAPSULES Capsules
TALUCK,BANGALORE
562 158, INDIA
115 NDA/MAL/H MEDREICH PLC LABOREX PARAFLAM IBUPROFEN 400MG + MEDREICH STERILAB INDIA ORAL SOLID 1.0X10.0X1 7/1/2004 GMP EXPIRED NONE
DP/3828 UGANDA + 325MG LTD-UNIT VI 54/2 ORDINARY 0.0 TABLET ON 29/11/2010
LIMITED PARACETAM BOODHIHALLI VI TABLETS BLISTER,1.0 FOR NBL Tablets
OL X10.0 Hard Gelatin
TABLET Capsules
BLISTER

116 NDA/MAL/H MEDREICH PLC LABOREX IBEX PARACETAM 325MG+20 MEDREICH LIMITED- INDIA ORAL SOLID 1.0X2.0X12. 7/1/2004 GMP EXPIRED MEDREICH
DP/3836 UGANDA OL+IBUPRO 0MG+30M 59 B&C ORDINARY 0 CAPSULE ON 29/11/2010 LIMITED (UNIT-
LIMITED FEN+CAFFEI G BOMMASANDRA CAPSULES BLISTER FOR NBL Tablets 7)-SURVEY NO.
NE INDUSTRIAL AREA, Hard Gelatin 11,12,13,14
ANEKAL TALUK, Capsules AND 15,
BANGALORE 560099 POOJARAMANA
INDIA HALLI VILLAGE,
BANGALORE
117 NDA/MAL/H MEDREICH PLC LABOREX MEDVITE MULTI- MULTIVITA MEDREICH STERILAB INDIA ORAL SOLID 1.0X1.0X21. 7/1/2005 GMP EXPIRED NONE
DP/4711 UGANDA GOLD INGREDIENT MINS LTD- ORDINARY 0 TABLET ON 29/11/2010
LIMITED 49(B&C)BOMMASAND TABLETS CONTAINER FOR NBL Tablets
RA IND. AREA Hard Gelatin
ANEKOL, Capsules
TALUCK,BANGALORE
560062, INDIA
118 NDA/MAL/H MERCK SHARP & PHILLIPS GARDASIL QUADRIVAL (20MCG+4 MERK & CO. INC- UNITED PARENTERAL 1.0X0.5 ML 7/1/2007 GMP EXPIRED NONE
DP/1675 DOHME BV PHARMACEUTICA ENT 0MCG+40 SUMNEYTOWN PIKE, STATES ORDINARY PRE- FILLED ON 2011-10-02
LS (UGANDA) HUMAN MCG+20M P.O BOX 4, WEST PRE-FILLED SYRINGE (1 FOR Rota Teq
LIMITED PAPILLOMA CG)/0.5ML POINT, SYRINGES DOSE),1.0X (Rotavirus)
VIRUS PENNSYLVANIA, U.S. 10.0X0.5 Gardasil (Human
RECOMBINA 19486, USA ML VIAL (1 Papilloma Virus)
NT VACCINE DOSE)
(TYPES 6,
119 NDA/MAL/H MERCK SHARP PHILLIPS ROTATEQ ROTAVIRUS 2.2M MERK & CO. INC- UNITED ORAL LIQUID 1.0X10.0 7/1/2011 GMP EXPIRED NONE
DP/4694 & DOHME PHARMACEUTICA LIVE IU+2.8M SUMNEYTOWN PIKE, STATES ORDINARY ML BOTTLE ON 2011-10-02
INTAPHARMA LS (UGANDA) REASSORTA IU+2.2M P.O BOX 4, WEST EMULSIONS FOR Rota Teq
LIMITED NT VIRUS IU+2.0M IU POINT, (Rotavirus)
G1+G2+G3+ PENNSYLVANIA, U.S. Gardasil (Human
G4 &P1 19486, USA Papilloma Virus)
120 NDA/MAL/H MSD (PTY) PHILLIPS IMPLANON ETONOGEST 68MG N.V. ORGANON- NETHERLAN PARENTERAL 1.0X68.0 7/1/2015 GMP EXPIRED NONE
DP/0013 LIMITED SA PHARMACEUTICA NXT REL KLOOSTERSTRAAT 6, DS RETARD MG ON 2018-05-21
LS (UGANDA) 5349 AB OSS, THE IMPLANTS IMPLANT FOR NBL
LIMITED NETHERLAND Implants, Tablets

121 NDA/MAL/H N.V. ORGANON PHILLIPS MARVELON DESOGESTR 150MG/30 N.V. ORGANON- NETHERLAN ORAL SOLID 1.0X100.0X 7/1/2015 GMP EXPIRED NONE
DP/5065 PHARMACEUTICA EL/ETHINYL MG KLOOSTERSTRAAT 6, DS ORDINARY 1.0X28.0 ON 2018-05-21
LS (UGANDA) ESTRADIOL 5349 AB OSS, THE TABLETS TABLET FOR NBL
LIMITED NETHERLAND BLISTER Implants, Tablets

122 NDA/MAL/H NAARI LTD ECHO DIVABO MIFEPRISTO 200MG+20 NAARI PHARMA INDIA ORAL SOLID 1.0X1.0 8/28/2019 RETENTION FEES NONE
DP/8293 PHARMACY (U) NE + 0MCG PRIVATE LIMITED- ORDINARY TABLET NOT PAID
LIMITED MISOPROST PLOT NO. 14-16, 55- COMBINATIO BLISTER +
OL 57, SECTOR-5, IIE, N PACK 1.0X4.0
PANT NAGAR TABLETS TABLETS OF
RUDRAPUR-263153 MISOPROST
DIST-U.S. NAGAR OL
UTTARAKHAND
123 NDA/MAL/H NATIONAL ANDYCO HISTABLOC RANITIDINE 25MG/ML NATIONAL NEPAL PARENTERAL 1.0X10.0X2. 11/29/2017 SUSPENDED DUE NONE
DP/7230 HEALTHCARE PHARMACY 2ML HYDROCHL HEALTHCARE PVT. ORDINARY 0 ML VIAL TO IMPURITY
PVT LTD (UGANDA) LTD ORIDE LTD.--WORKS: STERILE VIALS FOUND IN API
BLOCK CHHATAPIPRA-
3, BARA, NEPAL

124 NDA/MAL/H GITTOES GITTOES RANITIDINE RANITIDINE 25MG/ML NINGBO CHINA PARENTERAL 1.0X1.0X10. 7/1/2011 SUSPENDED DUE NONE
DP/2039 PHARMACEUTIC PHARMACEUTICA INJECTION DAHONGYING ORDINARY 0X2.0 ML TO IMPURITY
ALS LIMITED LS LIMITED USP PHARMACEUTICALS AMPOULES AMPOULE FOUND IN API
LTD- NO. 396 MIN
125 NDA/MAL/H AFRICURE ROYAL PHARMA OPRED PREDNISOL 5MG OSAKA INDIA ORAL SOLID 1.0X10.0X1 7/1/2008 FAILED GMP ON
DP/8308 PHARMACEUTIC 2011 LIMITED ONE PHARMACEUTICALS ORDINARY 0.0 TABLET 06/08/2018 FOR
ALS (INDIA) PVT, LTD-OLD TABLETS BLISTER LINES Non-Beta
PRIVATELIMITE NATIONAL HIGHWAY, lactam • Tablet
D SANKARDA 391350, (Coated and
VADODARA, GUJARAT, Uncoated) •
INDIA Hard gelatin
shell Capsule •
126 NDA/MAL/H PACIFIC HEALTHCARE LOMEXIN FENTICONA 2%W/W PACIFIC PAKISTAN TOPICAL 1.0X40.0 G 7/1/2005 GMP EXPIRED NONE
DP/6733 PHARMACEUTIC LTD. ZOLE PHARMACEUTICALS EXTERNAL TUBE ON 2017-12-09
ALS LTD LTD-30TH KILOMETRE CREAMS FOR NBL Tablets
NULTAN ROAD Hard gelatin
LAHORE PAKISTAN Capsules Oral
liquids Creams
and ointments
127 NDA/MAL/H PACIFIC HEALTHCARE NAPREBEN NAPROXEN 10%W/W PACIFIC PAKISTAN TOPICAL 1.0X25.0 G 7/1/2005 GMP EXPIRED NONE
DP/6735 PHARMACEUTIC LTD. BETAINE PHARMACEUTICALS EXTERNAL TUBE ON 2017-12-09
ALS LTD SODIUM LTD-30TH KILOMETRE GELS AND FOR NBL Tablets
NULTAN ROAD SOLS Hard gelatin
LAHORE PAKISTAN Capsules Oral
liquids Creams
and ointments
128 NDA/MAL/H PACIFIC HEALTHCARE PACIFIC'S DEXTROMET 10MG + PACIFIC PAKISTAN ORAL LIQUID 1.0X120.0 7/1/2011 GMP EXPIRED NONE
DP/6739 PHARMACEUTIC LTD. JACK & JILL HORPHAN + 2MG / 5ML PHARMACEUTICALS ORDINARY ML BOTTLE ON 2017-12-09
ALS LTD CHILDREN'S CHLORPHEN LTD-30TH KILOMETRE LIQUIDS FOR NBL Tablets
FORMULA IRAMINE NULTAN ROAD Hard gelatin
LAHORE PAKISTAN Capsules Oral
liquids Creams
and ointments
129 NDA/MAL/H PACIFIC HEALTHCARE RIFIN FORTE RIFAMPICIN 150MG + PACIFIC PAKISTAN ORAL SOLID 1.0X10.0X8. 7/1/2005 GMP EXPIRED NONE
DP/6742 PHARMACEUTIC LTD. +ISONIAZID 75MG+400 PHARMACEUTICALS ORDINARY 0 TABLET ON 2017-12-09
ALS LTD + MG+275M LTD-30TH KILOMETRE TABLETS BLISTER FOR NBL Tablets
PYRAZINAM G NULTAN ROAD Hard gelatin
IDE+ETHAM LAHORE PAKISTAN Capsules Oral
BUTOL liquids Creams
and ointments
130 NDA/MAL/H PACIFIC HEALTHCARE TYZORIN TIBEZONIU 0.05G/100 PACIFIC PAKISTAN TOPICAL 1.0X120.0 7/1/2005 GMP EXPIRED NONE
DP/6745 PHARMACEUTIC LTD. MOUTH M IODIDE ML PHARMACEUTICALS EXTERNAL ML BOTTLE ON 2017-12-09
ALS LTD WASH LTD-30TH KILOMETRE LIQUIDS FOR NBL Tablets
NULTAN ROAD Hard gelatin
LAHORE PAKISTAN Capsules Oral
liquids Creams
and ointments
131 NDA/MAL/H PACIFIC HEALTHCARE TYZORIN TIBEZONIU 5MG PACIFIC PAKISTAN ORAL SOLID 1.0X4.0X6.0 7/1/2011 GMP EXPIRED NONE
DP/6747 PHARMACEUTIC LTD. M IODIDE PHARMACEUTICALS ORDINARY LOZENGE ON 2017-12-09
ALS LTD LTD-30TH KILOMETRE LOZENGES STRIP FOR NBL Tablets
NULTAN ROAD Hard gelatin
LAHORE PAKISTAN Capsules Oral
liquids Creams
and ointments
132 NDA/MAL/H PHARCO WIDE SPECTRUM RANI RANITIDINE 150MG PHARCO EGYPT ORAL LIQUID 1.0X6.0X5.4 5/29/2019 SUSPENDED DUE NONE
DP/6607 PHARMACEUTIC ENTERPRISES (U) HYDROCHL PHARMACEUTICAL ORDINARY G SACHET TO IMPURITY
ALS LIMITED ORIDE IND. LTD-KM 31, EFFERVESCE FOUND IN API
ALEX, CAIRO DESERT NT
AMRIYA, ALEXANDRA POWDERS/G
RANULES

133 NDA/MAL/V MELO MELO HANMECTIN- IVERMECTIN 10MG/ML PHARMACEUTICAL VIETNAM PARENTERAL 1.0X100.0 11/29/2017 RETENTION FEES NONE
DP/8414 PHARMACEUTIC PHARMACEUTICA 100 AND VETERINARY ORDINARY I ML VIAL NOT PAID
ALS LIMITED LS LIMITED MATERIAL JSC M VIALS
(HANVET)-IDUST.
ZONE: PHO NOI A, MY
HAO DISTRTICT,
HUNG YEN PROVINCE
VIETNAM
134 NDA/MAL/H F. HOFFMANN- LABOREX XELODA CAPECITABI 500MG PRODUCTOS ROCHE MEXICO ORAL SOLID 1.0X12.0X1 7/1/2016 GMP EXPIRED NONE
DP/6445 LA ROCHE LTD UGANDA NE S.A DE CV -TOLUCA ORDINARY 0.0 TABLET ON 2017-09-09
LIMITED MEXICO TABLETS BLISTER
Tablets
135 NDA/MAL/H F. HOFFMANN- LABOREX XELODA CAPECITABI 150MG PRODUCTOS ROCHE MEXICO ORAL SOLID 1.0X6.0X10. 7/1/2016 GMP EXPIRED NONE
DP/6803 LA ROCHE LTD UGANDA NE S.A DE CV -TOLUCA ORDINARY 0 TABLET ON 2017-09-09
LIMITED MEXICO TABLETS BLISTER
Tablets

136 NDA/MAL/H ACINO PHARMA GOODMAN FERRACIN IRON (III) 20MG/ML RAFARM S.A-AGIO GREECE PARENTERAL 1.0X5.0X5.0 7/1/2016 DECLINED BEING NONE
DP/6131 AG INTERNATIONAL HYDROXIDE LOUKA STR PEANIA ORDINARY I ML INSPECTED FOR
LTD SUCROSE ATTIKI V AMPOULES AMPOULE GMP BY NDA
COMPLEX

137 NDA/MAL/H REMINGTON HEALTHCARE OPTA- ATROPINE 1%W/V REMINGTON PAKISTAN OPHTHALMI 1.0X10.0 7/1/2001 GMP EXPIRED NONE
DP/0506 PHARMACEUTIC LTD. ATROPINE SULPHATE PHARMACEUTICAL C DROPS ML VIAL ON 2018-11-06
AL INDUSTRIES EYE DROPS INDUS. PVT LTD-, 117 FOR Non Beta
PVT LTD ALLAM lactam. • Oral
tablets. • Hard
gelatin capsules.
• Oral liquids •
Eye drops • Ear
138 NDA/MAL/H REMINGTON HEALTHCARE AMYGYDEX TOBRAMYCI 3MG+1MG REMINGTON PAKISTAN OPHTHALMI 1.0X5.0 ML 7/1/2014 GMP EXPIRED NONE
DP/0794 PHARMACEUTIC LTD. N/DEXAMET /ML PHARMACEUTICALS C DROPS BOTTLE ON 2018-11-06
AL INDUSTRIES HASONE (PVT) LTD-18KM, FOR Non Beta
PVT LTD MULTAN ROAD, lactam. • Oral
LAHORE 53800, tablets. • Hard
PAKISTAN gelatin capsules.
• Oral liquids •
Eye drops • Ear
139 NDA/MAL/H REMINGTON HEALTHCARE PREDNICOL PREDNISOL 5MG/2MG REMINGTON PAKISTAN OPHTHALMI 1.0X10.0 7/1/1999 GMP EXPIRED NONE
DP/1549 PHARMACEUTIC LTD. EYE DROPS ONE/CHLOR PHARMACEUTICAL C DROPS ML VIAL ON 2018-11-06
AL INDUS. PVT AMPHENIC INDUS. PVT LTD-, 117 FOR Non Beta
LTD PAKISTAN OL ALLAM lactam. • Oral
tablets. • Hard
gelatin capsules.
• Oral liquids •
Eye drops • Ear
140 NDA/MAL/H REMINGTON HEALTHCARE REMICOL CHLORAMP 1%W/V REMINGTON PAKISTAN OTIC DROPS 1.0X10.0 7/1/1999 GMP EXPIRED NONE
DP/1714 PHARMACEUTIC LTD. EAR DROPS HENICOL PHARMACEUTICAL ML BOTTLE ON 2018-11-06
AL INDUS. PVT INDUS. PVT LTD-, 117 FOR Non Beta
LTD PAKISTAN ALLAM lactam. • Oral
tablets. • Hard
gelatin capsules.
• Oral liquids •
Eye drops • Ear
141 NDA/MAL/H REMINGTON HEALTHCARE SEPRODERM SALICYLIC 3.6 + 2.4 REMINGTON PAKISTAN TOPICAL 1.0X20.0 G 7/1/1998 GMP EXPIRED NONE
DP/2137 PHARMACEUTIC LTD. OINTMENT ACID + MG PHARMACEUTICAL EXTERNAL TUBE ON 2018-11-06
AL INDUS. PVT SULPHUR INDUS. PVT LTD-, 117 OINTMENTS FOR Non Beta
LTD PAKISTAN COMPOUND ALLAM lactam. • Oral
tablets. • Hard
gelatin capsules.
• Oral liquids •
Eye drops • Ear
142 NDA/MAL/H REMINGTON HEALTHCARE BETADROP-N BETAMETHA 0.1 %W/V + REMINGTON PAKISTAN OPHTHALMI 1.0X7.5 ML 7/1/1999 GMP EXPIRED NONE
DP/2280 PHARMACEUTIC LTD. SONE + 0.5 %W/V PHARMACEUTICAL C DROPS VIAL ON 2018-11-06
AL INDUS. PVT NEOMYCIN INDUS. PVT LTD-, 117 FOR Non Beta
LTD PAKISTAN ALLAM lactam. • Oral
tablets. • Hard
gelatin capsules.
• Oral liquids •
Eye drops • Ear
143 NDA/MAL/H REMINGTON HEALTHCARE OPTACHLOR CHLORAMP 0.5%W/V REMINGTON PAKISTAN OPHTHALMI 1.0X10.0 7/1/1999 GMP EXPIRED NONE
DP/3068 PHARMACEUTIC LTD. EYE DROPS HENICOL PHARMACEUTICAL C DROPS ML VIAL ON 2018-11-06
AL INDUS. PVT INDUS. PVT LTD-, 117 FOR Non Beta
LTD PAKISTAN ALLAM lactam. • Oral
tablets. • Hard
gelatin capsules.
• Oral liquids •
Eye drops • Ear
144 NDA/MAL/H REMINGTON HEALTHCARE OPTADEX-N DEXAMETH 1MG/3MG REMINGTON PAKISTAN OPHTHALMI 1.0X5.0 ML 7/1/1999 GMP EXPIRED NONE
DP/3221 PHARMACEUTIC LTD. EYE DROPS ASONE/NEO PHARMACEUTICAL C DROPS VIAL ON 2018-11-06
AL INDUS. PVT MYCIN INDUS. PVT LTD-, 117 FOR Non Beta
LTD PAKISTAN ALLAM lactam. • Oral
tablets. • Hard
gelatin capsules.
• Oral liquids •
Eye drops • Ear
145 NDA/MAL/H REMINGTON HEALTHCARE METHACHLO DEXAMETH 1MG/2MG REMINGTON PAKISTAN OPHTHALMI 1.0X5.0 ML 7/1/1999 GMP EXPIRED NONE
DP/4768 PHARMACEUTIC LTD. R EYE DROPS ASONE/CHL PHARMACEUTICAL C DROPS BOTTLE ON 2018-11-06
AL INDUSTRIES ORAMPHEN INDUS. PVT LTD-, 117 FOR Non Beta
PVT LTD ICOL ALLAM lactam. • Oral
tablets. • Hard
gelatin capsules.
• Oral liquids •
Eye drops • Ear
146 NDA/MAL/H REMINGTON HEALTHCARE ROCIP EYE CIPROFLOXA 3MG/ML REMINGTON PAKISTAN OPHTHALMI 1.0X5.0 ML 7/1/2016 GMP EXPIRED NONE
DP/6250 PHARMACEUTIC LTD. DROPS CIN PHARMACEUTICAL C DROPS BOTTLE ON 2018-11-06
AL INDUSTRIES HYDROCHL INDUSTRIES (PVT) LTD- FOR Non Beta
PVT LTD ORIDE 18 KM MULTAN ROAD lactam. • Oral
LAHORE 53800 tablets. • Hard
PAKISTAN gelatin capsules.
• Oral liquids •
Eye drops • Ear
147 NDA/MAL/H PFIZER LABOREX NORVASC AMLODIPIN 5MG R-PHARM GERMANY GERMANY ORAL SOLID 1.0X3.0X10. 7/1/1997 GMP EXPIRED NONE
DP/3763 LABORATORIES UGANDA E GMBH -HEINRICH- ORDINARY 0 TABLET ON 2018-08-25
PTY LTD LIMITED MACH-STRASSE TABLETS BLISTER FOR NBL Coated
35,89257,ILLERTISSEN and uncoated
,GERMANY tablets

148 NDA/MAL/H SANDOZ GMBH, SURGIPHARM (U) OXYTOCIN OXYTOCIN 10IU/ML SALUTAS PHARMA GERMANY PARENTERAL 1.0X10.0 11/27/2019 GMP expired on NONE
DP/7221 KUNDL LIMITED GMBH-OTTO-VON- ORDINARY AMPOULE 16-02-2019 FOR
GUERICKE ALLEE-1, AMPOULES CARTON • Tablets •
39179 BARLEBEN Capsules

149 NDA/MAL/H SANDOZ GMBH, SURGIPHARM (U) OXYTOCIN OXYTOCIN 5IU/1ML SALUTAS PHARMA GERMANY PARENTERAL 1.0X10.0 11/27/2019 GMP expired on NONE
DP/8687 KUNDL LIMITED GMBH-OTTO-VON- ORDINARY AMPOULE 16-02-2019 FOR
GUERICKE ALLEE-1, AMPOULES CARTON • Tablets •
39179 BARLEBEN Capsules
150 NDA/MAL/H NORVATIS SURGIPHARM (U) CURAM AMOXICILLI 125MG + SANDOZ GMBH INDIA ORAL LIQUID 1.0X60.0 1/7/2014 GMP EXPIRED NONE
DP/0095 PHARMA LIMITED N+ 31.25MG/5 (NORVATIS PHARMA ORDINARY ML BOTTLE ON 01/07/2019
SERVICES INC. CLAVULANA ML SERVICES INC) - DRY FOR SVP (Dry
TE BIOCHEMIESTRABE SUSPENSION powders) -
10, A-6250 KUNDL, S/SYRUPS/DR Penicillin
TYROL OPS Tabelts, SVP (Dry
powders), and
HGC -
151 NDA/MAL/H SANDOZ KENYA SURGIPHARM (U) BIODROXIL CEFADROXIL 250MG/5M SANDOZ GMBH- AUSTRIA ORAL LIQUID 1.0X60.0 7/1/2013 GMP EXPIRED NONE
DP/0640 C/O NOVARTIS LIMITED 250MG/5ML (ANHYDROU L BIOCHEMIESTRASSE ORDINARY ML BOTTLE ON 01/07/2019
PHARMA S) 10, A6250 KUNDL, DRY FOR SVP (Dry
SERVICES INC TYROL, AUSTRIA SUSPENSION powders) -
S/SYRUPS/DR Penicillin
OPS Tabelts, SVP (Dry
powders), and
HGC -
152 NDA/MAL/H NOVARTIS SURGIPHARM (U) CURAM AMOXICILLI 875 MG + SANDOZ GMBH- AUSTRIA ORAL SOLID 1.0X7.0X2.0 7/1/2014 GMP EXPIRED NONE
DP/0915 PHARMA LIMITED N+ 125 MG BIOCHEMIESTRASSE ORDINARY TABLET ON 01/07/2019
SERVICES INC CLAVULANI 10, A6250 KUNDL, FILM- STRIP FOR SVP (Dry
C ACID TYROL, AUSTRIA COATED powders) -
TABLETS Penicillin
Tabelts, SVP (Dry
powders), and
HGC -
153 NDA/MAL/H SANDOZ KENYA SURGIPHARM (U) CURAM AMOXYCILLI 500MG+12 SANDOZ GMBH- AUSTRIA ORAL SOLID 1.0X7.0X2.0 7/1/2016 GMP EXPIRED NONE
DP/1423 C/O NOVARTIS LIMITED N+ 5MG BIOCHEMIESTRASSE ORDINARY TABLET ON 01/07/2019
PHARMA POTASSIUM 10, A6250 KUNDL, FILM- BLISTER FOR SVP (Dry
SERVICES INC CLAVULANA TYROL, AUSTRIA COATED powders) -
TE TABLETS Penicillin
Tabelts, SVP (Dry
powders), and
HGC -
154 NDA/MAL/H SANDOZ GMBH SURGIPHARM (U) PIPTAZO PIPERACILLI 2G SANDOZ GMBH- AUSTRIA PARENTERAL 1.0X2.25 G 7/1/2016 GMP EXPIRED NONE
DP/6160 C/O NOVARTIS LIMITED 2.25G N BIOCHEMIESTRAΒE 10 ORDINARY VIAL ON 01/07/2019
PHARMA A6250 KUNDL, TYROL, VIALS FOR SVP (Dry
SERVICES. AUSTRIA powders) -
Penicillin
Tabelts, SVP (Dry
powders), and
HGC -
155 NDA/MAL/H SANDOZ GMBH SURGIPHARM (U) CEFTRIAXON CEFTRIAXO 1G SANDOZ GMBH- AUSTRIA PARENTERAL 1.0X1.0 G 7/1/2016 GMP EXPIRED NONE
DP/6193 C/O NOVARTIS LIMITED E SANDOZ NE SODIUM BIOCHEMIESTRAΒE 10 ORDINARY VIAL ON 01/07/2019
PHARMA A6250 KUNDL, TYROL, DRY VIALS FOR SVP (Dry
SERVICES. AUSTRIA powders) -
Penicillin
Tabelts, SVP (Dry
powders), and
HGC -
156 NDA/MAL/H NORVATIS SURGIPHARM (U) CURAM AMOXICILLI 250MG + SANDOZ GMBH- AUSTRIA ORAL LIQUID 1.0X60.0 7/1/2016 GMP EXPIRED NONE
DP/6233 PHARMA LIMITED 250MG/5ML N + 62.5MG BIOCHEMIESTRAΒE 10 ORDINARY ML VIAL ON 01/07/2019
SERVICES INC. CLAVULANA /5ML A6250 KUNDL, TYROL, OTHER FOR SVP (Dry
TE AUSTRIA POWDERS/G powders) -
RANULES Penicillin
Tabelts, SVP (Dry
powders), and
HGC -
157 NDA/MAL/H SANDOZ GMBH SURGIPHARM (U) PIPTAZO PIPERACILLI 4G+0.5G SANDOZ GMBH- AUSTRIA PARENTERAL 1.0X4.5 ML 7/1/2016 GMP EXPIRED NONE
DP/6731 C/O NOVARTIS LIMITED 4.5G N BIOCHEMIESTRAΒE 10 ORDINARY VIAL ON 01/07/2019
PHARMA SODIUM+TA A6250 KUNDL, TYROL, DRY VIALS FOR SVP (Dry
SERVICES INC ZOBACTAM AUSTRIA powders) -
SODIUM Penicillin
Tabelts, SVP (Dry
powders), and
HGC -
158 NDA/MAL/H SANDOZ GMBH, SURGIPHARM (U) AMOXICILLIN AMOXICILLI 250 MG SANDOZ GMBH AUSTRIA ORAL SOLID 1.0X10.0X1 7/1/2017 GMP EXPIRED NONE
DP/7228 KUNDL LIMITED 250MG N BIOCHEMISTRASSE 10- ORDINARY 0.0 TABLET ON 01/07/2019
DISPERSIBLE TRIHYDRATE 6250 KUNDL, AUSTRIA SOLUBLE BLISTER FOR SVP (Dry
TABLETS TABLETS powders) -
Penicillin
Tabelts, SVP (Dry
powders), and
HGC -
159 NDA/MAL/H ABACUS ABACUS PHARMA AB-DOX-100 DOXYCYCLI 100MG JIANGSU PENGYAO CHINA ORAL SOLID 1.0X10.0X1 7/1/2015 FAILED GMP ON NONE
DP/0300 PHARMA LTD (AFRICA) LIMITED NE PHARMACEUTICALS ORDINARY 0.0 2018-08-28 FOR
CO. LTD-NO. 10 CAPSULES CAPSULE Non Beta
CHAQUAN BLISTER Lactam: • SVP-
ROAD,YIXING CITY, Solutions in
CHINA SHANDONG Ampoules •
XIER KANGTAI Tablets • Hard
PHARMACEUTICALS Gelatin Capsules
160 NDA/MAL/H ABACUS ABACUS PHARMA INDOCAP-25 INDOMETH 25 MG SHANDONG XIER CHINA ORAL SOLID 1.0X10.0X1 7/1/2014 FAILED GMP ON NONE
DP/0554 PHARMA LTD (AFRICA) LIMITED ACIN KANGTAI ORDINARY 0.0 2018-08-31 FOR
PHARMACEUTICALS CAPSULES CAPSULE Non-Beta
CO. LTD PRIVATE- BLISTER Lactam dosage
PRIVATE ECONOMY forms: • Small
ZONE,XINYAN TOWN, Volume
YANZHOU DISTRICT, Parenterals
JINING –Solutions in
161 NDA/MAL/H ABACUS ABACUS PHARMA GMYCIN-80 GENTAMYCI 80MG/2ML JIANGSU PENGYAO CHINA PARENTERAL 1.0X100.0X 7/1/2013 FAILED GMP ON NONE
DP/1188 PHARMA (A) (AFRICA) LIMITED N SULPHATE PHARMACEUTICALS ORDINARY 2.0 ML 2018-08-28 FOR
LTD. CO. LTD -NO. 10 AMPOULES AMPOULE Non Beta
CHAQUAN ROAD Lactam: • SVP-
YIXING CITY JIANGSU Solutions in
PROVINCE Ampoules •
SHANDONG XIER Tablets • Hard
KANGTAI Gelatin Capsules
162 NDA/MAL/H BEIJING HOLLEY SUPER PARACETAM PARACETAM 500MG SHANDONG XIER CHINA ORAL SOLID 1.0X1000.0 7/1/2007 FAILED GMP ON NONE
DP/1534 COTEC PHARMA PHARMACEUTICA OL OL KANGTAI ORDINARY TABLET 2018-08-31 FOR
CHINA LS LIMITED PHARMACEUTICAL CO TABLETS CONTAINER Non-Beta
LTD-YANZHOU CITY, ,1.0X10.0X1 Lactam dosage
CHINA 0.0 TABLET forms: • Small
BLISTER,1.0 Volume
X100.0X10. Parenterals
0 TABLET –Solutions in
163 NDA/MAL/H BEIJING HOLLEY SUPER TETRACYCLI TETRACYCLI 250MG SHANDONG XIER CHINA ORAL SOLID 1.0X10.0X1 7/1/2011 FAILED GMP ON NONE
DP/1991 COTEC PHARMA PHARMACEUTICA NE NE KANGTAI ORDINARY 0.0 2018-08-31 FOR
CHINA LS LIMITED PHARMACEUTICAL CO CAPSULES CAPSULE Non-Beta
LTD-YANZHOU CITY, BLISTER,1.0 Lactam dosage
CHINA X1000.0 forms: • Small
CAPSULE Volume
CONTAINER Parenterals
,1.0X100.0X –Solutions in
164 NDA/MAL/H ROYAL PHARMA ROYAL PHARMA AMINOPHYL AMINOPHYL 100MG SHANDONG XIER CHINA ORAL SOLID 1.0X500.0 7/1/2008 FAILED GMP ON NONE
DP/2656 2011 LIMITED 2011 LIMITED LINE LINE KANGTAI ORDINARY TABLET 2018-08-31 FOR
PHARMACEUTICAL TABLETS CONTAINER Non-Beta
CO. LTD-PRIVATE ,1.0X10.0X1 Lactam dosage
ECONOMY 0.0 TABLET forms: • Small
ZONE,YANZHOU BLISTER Volume
DISTRICT,SHANDONG, Parenterals
CHINA PR –Solutions in
165 NDA/MAL/H ABACUS ABACUS PHARMA R-ETHER ARTEMETHE 80MG/ML JIANGSU PENGYAO CHINA PARENTERAL 1.0X8.0 ML 7/1/2014 FAILED GMP ON NONE
DP/3487 PHARMA LTD (AFRICA) LIMITED R PHARMACEUTICALS ORDINARY AMPOULE,1 2018-08-28 FOR
CO. LTD -NO. 10 AMPOULES .0X6.0 ML Non Beta
CHAQUAN ROAD AMPOULE Lactam: • SVP-
YIXING CITY JIANGSU Solutions in
PROVINCE Ampoules •
SHANDONG XIER Tablets • Hard
KANGTAI Gelatin Capsules
166 NDA/MAL/H BEIJING HOLLEY SUPER AMOXICILLIN AMOXICILLI 250MG SHANDONG XIER CHINA ORAL SOLID 1.0X1000.0 7/1/2010 FAILED GMP ON NONE
DP/3625 COTEC PHARMA PHARMACEUTICA N KANGTAI ORDINARY CAPSULE 2018-08-31 FOR
CHINA LS LIMITED PHARMACEUTICAL CO CAPSULES CONTAINER Non-Beta
LTD-YANZHOU CITY, ,1.0X10.0X1 Lactam dosage
CHINA 0.0 forms: • Small
CAPSULE Volume
BLISTER Parenterals
–Solutions in
167 NDA/MAL/H BEIJING HOLLEY SUPER METRONIDA METRONIDA 200MG SHANDONG XIER CHINA ORAL SOLID 1.0X100.0X 7/1/2011 FAILED GMP ON NONE
DP/4840 COTEC PHARMA PHARMACEUTICA ZOLE ZOLE KANGTAI ORDINARY 10.0 2018-08-31 FOR
CHINA LS LIMITED PHARMACEUTICALS TABLETS TABLET Non-Beta
CO. LTD PRIVATE- BLISTER,1.0 Lactam dosage
PRIVATE ECONOMY X10.0X10.0 forms: • Small
ZONE,XINYAN TOWN, TABLET Volume
YANZHOU DISTRICT, BLISTER,1.0 Parenterals
JINING X1000.0 –Solutions in
168 NDA/MAL/H BEIJING HOLLEY- SUPER INDOMETACI INDOMETH 25MG SHANDONG XIER CHINA ORAL SOLID 1.0X1000.0 7/1/2009 FAILED GMP ON NONE
DP/5325 COTEC PHARMACEUTICA N ACIN KANGTAI ORDINARY CAPSULE 2018-08-31 FOR
PHARMACEUTIC LS LIMITED PHARMACEUTICALS CAPSULES CONTAINER Non-Beta
ALS CO.,LTD CO. LTD PRIVATE- ,1.0X100.0X Lactam dosage
PRIVATE ECONOMY 10.0 forms: • Small
ZONE,XINYAN TOWN, CAPSULE Volume
YANZHOU DISTRICT, BLISTER,1.0 Parenterals
JINING X10.0X10.0 –Solutions in
169 NDA/MAL/H ABACUS ABACUS PHARMA PHENICOL- CHLORAMP 250MG JIANGSU PENGYAO CHINA ORAL SOLID 1.0X10.0X1 7/1/2015 FAILED GMP ON NONE
DP/5446 PHARMA LTD (AFRICA) LIMITED 250 HENICOL PHARMACEUTICALS ORDINARY 0.0 2018-08-28 FOR
CO. LTD -NO. 10 CAPSULES CAPSULE Non Beta
CHAQUAN ROAD BLISTER Lactam: • SVP-
YIXING CITY JIANGSU Solutions in
PROVINCE Ampoules •
SHANDONG XIER Tablets • Hard
KANGTAI Gelatin Capsules
170 NDA/MAL/H ABACUS ABACUS PHARMA EXPEN BENZYLPENI 1MU SHANDONG XIER CHINA PARENTERAL 1.0X50.0X1. 7/1/2011 FAILED GMP ON REYOUNG
DP/5497 PHARMA (A) (AFRICA) LIMITED CILLIN KANGTAI ORDINARY 0 MU VIAL 2018-08-31 FOR PHARMACEUTIC
LTD. PHARMACEUTICALS DRY VIALS Non-Beta AL CO. LTD-NO.
CO. LTD PRIVATE- Lactam dosage 6 ERLANGSHAN
PRIVATE ECONOMY forms: • Small ROAD, YIYUAN,
ZONE,XINYAN TOWN, Volume SHANDONG
YANZHOU DISTRICT, Parenterals 256100
JINING –Solutions in
171 NDA/MAL/H STRIDES ROYAL PHARMA MOXIRONE AMOXYCILLI 250MG SHANDONG XIER INDIA ORAL SOLID 1.0X10.0X1 7/1/1997 FAILED GMP ON UNI
DP/6672 ARCOLAB LTD 2011 LIMITED 250 N KANGTAI ORDINARY 0.0 2018-08-31 FOR MEDICOLABS.-
CAPSULES PHARMACEUTICALS CAPSULES CAPSULE Non-Beta 21-22
CO. LTD PRIVATE- BLISTER,1.0 Lactam dosage PHARMACITY
PRIVATE ECONOMY X1000.0 forms: • Small SELAQUI
ZONE,XINYAN TOWN, CAPSULE Volume DEHRADUN
YANZHOU DISTRICT, CONTAINER Parenterals 248197
JINING –Solutions in
172 NDA/MAL/H SINO AFRICA SINO AFRICA BENZATHINE BENZATHIN 2400000 SHIJIAZHUANG CHINA PARENTERAL 1.0X10.0 7/1/2009 FACILITY NO.188 NONE
DP/2846 MEDICINES AND MEDICINES & BENZYL E BENZYL I.U PHARMA GROUP, ORDINARY VIAL and 47 NO
HEALTH LTD HEALTH LTD PENICILLIN PENICILLIN ZHOUGNUO, DRY VIALS CARTON,1.0 LONGER
FOR PHARMACEUTICAL- X50.0 VIAL EXIST.ONLY
INJECTION N0188 GONGNONG CARTON NO.88 EXISTS
ROAD, SHIJIAZHUANG
CITY HEBEI PROVINCE,
PEOPLE'S REP. CHINA
173 NDA/MAL/H SINO AFRICA SINO AFRICA BENZYL BENZYLPENI 1000000 SHIJIAZHUANG CHINA PARENTERAL 1.0X50.0 7/1/2009 FACILITY NO.188 NONE
DP/4308 MEDICINES AND MEDICINES & PENICILLIN CILLIN I.U PHARMA GROUP, ORDINARY VIAL and 47 NO
HEALTH LTD HEALTH LTD SODIUM SODIUM ZHOUGNUO, DRY VIALS CARTON,1.0 LONGER
PHARMACEUTICAL- X10.0 VIAL EXIST.ONLY
N0188 GONGNONG CARTON NO.88 EXISTS
ROAD, SHIJIAZHUANG
CITY HEBEI PROVINCE,
PEOPLE'S REP. CHINA
174 NDA/MAL/H SECOND SINO AFRICA FORTIFIED FORTIFIED 4MEGA SHIJIAZHUANG CHINA PARENTERAL 1.0X10.0 7/1/1998 FACILITY NO.188 NONE
DP/5642 PHARMACEUTIC MEDICINES & PROCAINE PROCAINE UNITS PHARMA GROUP, ORDINARY VIAL and 47 NO
ALS HEALTH LTD PENICILLIN PENICILLIN ZHOUGNUO, DRY VIALS CARTON,1.0 LONGER
PHARMACEUTICAL- X50.0 VIAL EXIST.ONLY
N0188 GONGNONG CARTON NO.88 EXISTS
ROAD, SHIJIAZHUANG
CITY HEBEI PROVINCE,
PEOPLE'S REP. CHINA
175 NDA/MAL/H ROYAL PHARMA ROYAL PHARMA FORTIFIED FORTIFIED 4 MEGA SHIJIAZHUANG CHINA PARENTERAL 1.0X50.0 7/1/2000 FACILITY NO.188 NONE
DP/3847 2011 LIMITED PROCAINE PROCAINE UNIT PHARMA GROUP- ORDINARY VIAL and 47 NO
PENICILLIN PENICILLIN ZHOUGNUO, DRY VIALS CARTON,1.0 LONGER
PHARMACEUTICAL X10.0 VIAL EXIST.ONLY
CARTON NO.88 EXISTS

176 NDA/MAL/H STEDMAN VEERAM MICOBACT MICONAZOL 2%W/W + STEDMAN INDIA TOPICAL 1.0X30.0 G 7/1/2011 RETENTION FEES NONE
DP/4871 PHARMACEUTIC HEALTHCARE (U) POWDER E+ 0.05%W/W PHARMACEUTICALS EXTERNAL CONTAINER NOT PAID
ALS PVT. LTD LIMITED CHLOROHEX PVT LIMITED-NO. C-4, POWDERS ,1.0X50.0 G
IDINE SIDCO CONTAINER
PHARMACEUTICAL ,1.0X75.0 G
COMPLEX, ALATHUR, CONTAINER
THIRUPORUR, ,1.0X100.0
KANCHEEPURAM DIST G
177 NDA/MAL/H SUNRISE ROYAL PHARMA SUNTAC RANITIDINE 150 MG SUNRISE INDIA ORAL SOLID 1.0X10.0X1 7/25/2018 SUSPENDED DUE NONE
DP/7146 INTERNATIONAL 2011 LIMITED HYDROCHL INTERNATIONAL LABS ORDINARY 0.0 TABLET TO IMPURITY
LABS LTD ORIDE LTD.-PLOT NO. 100, FILM- BLISTER FOUND IN API
LANE 5, SECTOR II, COATED
PHASE II TABLETS
IDA CHERLAPALLY,
HYDERABAD-500 051
178 NDA/MAL/H SWISS HEALTHCARE VITAGLOBIN MULTI- MULTI- SWISS PAKISTAN ORAL LIQUID 1.0X90.0 7/1/2001 FAILED GMP ON NONE
DP/2591 PHAMACEAUTIC LTD. SYRUP INGREDIENT INGREDIEN PHARMACEUTICALS ORDINARY ML THE 3-
AL PUT LTD T PVT LTD-A159 SINDH SYRUPS BOTTLE,1.0 4/12/2018 FOR
INDUSTRIAL AREA X250.0 ML Non-beta
KARACHI BOTTLE lactam: • Tablets
(Coated and
Uncoated) •
Hard gelatin
179 NDA/MAL/H SWISS HEALTHCARE DEXA-N DEXAMETH 1%W/W+0. SWISS PAKISTAN TOPICAL 1.0X15.0 G 7/1/2003 FAILED GMP ON NONE
DP/3330 PHAMACEAUTIC LTD. ASONE+NEO 5%W/W PHARMACEUTICALS EXTERNAL TUBE THE 3-
AL PUT LTD MYCIN PVT LTD-A159 SINDH CREAMS 4/12/2018 FOR
SULPHATE INDUSTRIAL AREA Non-beta
KARACHI lactam: • Tablets
(Coated and
Uncoated) •
Hard gelatin
180 NDA/MAL/H ZEE ZEE ZEECEL 200 CELECOXIB 200MG THE MADRAS INDIA ORAL SOLID 1.0X10.0X1 7/1/2017 RETENTION FEES NONE
DP/7681 PHARMACEUTIC PHARMACEUTICA PHARMACEUTICALS..- ORDINARY 0.0 NOT PAID
ALS LTD LS LIMITED NO. 137B, OLD CAPSULES CAPSULE
MAHABALIPURAM BLISTER
ROAD, KARAPAKKAM,
CHENNAI 600096

181 NDA/MAL/H TRIVENI AIVEEN (U) EXBRO TERBUTALIN 1.25MG/2 TRIVENI INDIA ORAL LIQUID 1.0X100.0 7/1/2013 FAILED GMP NONE
DP/1165 FORMULATIONS LIMITED E MG/50MG FORMULATIONS LTD .- ORDINARY ML BOTTLE INSPECTION
LIMITED SULPHATE/ PLOT NO. 52, 53,54 LIQUIDS (ORAL LIQUID
BROMOHEXI ALEAP INDUSTRIAL LINE) ON 08-
NE/GUAIFE ESTATE SURAMPALLI 09/3/2018
NESIN VILLAGE
GANNAVARAM
MANDAL KRISHNA
182 NDA/MAL/H UMEDICA GITTOES UMETAC-150 RANITIDINE 150MG UMEDICA INDIA ORAL SOLID 1.0X10.0X1 7/1/2006 SUSPENDED DUE NONE
DP/2489 LABORATORIES PHARMACEUTICA LABORATORIES PVT ORDINARY 0.0 TABLET TO IMPURITY
PVT LTD LS LIMITED LTD-PLOT NO. 221, FILM- BLISTER FOUND IN API
2ND PHASE, GIDC, COATED
VAPI 396195, TABLETS
GUJARAT. INDIA.

183 NDA/MAL/H UNIQUE TATA UGANDA RANTAB-150 RANITIDINE 150MG UNIQUE INDIA ORAL SOLID 1.0X10.0X1 7/1/1997 SUSPENDED DUE NONE
DP/1953 PHARMACEUTIC LIMITED PHARMACEUTICAL ORDINARY 0.0 TABLET TO IMPURITY
ALS LABORATORIES (A TABLETS BLISTER FOUND IN API
LABORATORIES DIV. OF J.B
CHEMICALS &
PHARMACEUTICALS
LTD)--216-219 GIDC
INDUSTRIAL AREA
184 NDA/MAL/H UNIQUE TATA UGANDA RANTAB RANITIDINE 25MG/ML UNIQUE INDIA PARENTERAL 1.0X10.0X2. 7/1/1997 SUSPENDED DUE NONE
DP/3869 PHARMACEUTIC LIMITED INJECTION PHARMACEUTICAL ORDINARY 0 ML TO IMPURITY
ALS LABORATORIES (A AMPOULES AMPOULE FOUND IN API
LABORATORIES DIV. OF J.B
CHEMICALS &
PHARMACEUTICALS
LTD)--216-219 GIDC
INDUSTRIAL AREA
185 NDA/MAL/V UNIVET LTD BIMEDA TRAMAZOLE ALBENDAZO 10%W/V UNIVET LTD- IRELAND ORAL LIQUID 1.0X5.0 L 7/1/2000 GMP EXPIRED MEDISEL KENYA
DP/5968 UGANDA LE TULLYVIN, ORDINARY JERRYCAN,1 ON 2017-11-14 LTD - -LR NO :
LIMITED COOTEHILL, COUNTY SUSPENSION .0X2.5 L FOR NBL (LVPs 4953 / 1209,
CAVAN, IRELAND. S JERRYCAN,1 and SVPs GENERAL KAGO
.0X120.0 solutions and ROAD, P.O. BOX
ML suspensions in 5401000, THIKA -
BOTTLE,1.0 glass bottles, KENYA
X1.0 L Oral
186 NDA/MAL/V UNIVET LTD BIMEDA CURAFLUKE FENBENDAZ 5%W/V+5% UNIVET LTD- IRELAND ORAL LIQUID 1.0X1.0 L GMP EXPIRED MEDISEL KENYA
DP/8181 UGANDA OLE+RAFOX W/V TULLYVIN, ORDINARY JERRYCAN ON 2017-11-14 LTD - -LR NO :
LIMITED ANIDE COOTEHILL, COUNTY LIQUIDS FOR NBL (LVPs 4953 / 1209,
CAVAN, IRELAND. and SVPs GENERAL KAGO
solutions and ROAD, P.O. BOX
suspensions in 5401000, THIKA -
glass bottles, KENYA
Oral
187 NDA/MAL/V V.M.D.N.V ERAM UGANDA ENROVETO- ENROFLOXA 200MG/ML VMD NV HOGE BELGIUM ORAL LIQUID 1.0X1000.0 7/1/2010 GMP EXPIRED NONE
DP/4435 LIMITED 20 CIN MAUW--HOGE MUW ORDINARY ML ON 03-02-19
900-B2370, LIQUIDS BOTTLE,1.0 FOR NBL (Large
ARENDONK X100.0 ML Volume
BOTTLE Parenteral
Injections, Small
Volume
Parenteral
188 NDA/MAL/V V.M.D.N.V ERAM UGANDA IVERVETO-1 IVERMECTIN 10MG/ML VMD NV HOGE BELGIUM PARENTERAL 1.0X1.0X50. 7/1/2010 GMP EXPIRED NONE
DP/4443 LIMITED MAUW-HOGE MUW ORDINARY 0 ML ON 03-02-19
900, 2370, VIALS BOTTLE,1.0 FOR NBL (Large
ARENDONK X100.0 ML Volume
BOTTLE Parenteral
Injections, Small
Volume
Parenteral
189 NDA/MAL/V VMD NV HOGE ERAM UGANDA DOXYVET- DOXYCYCLI 500MG/G VMD NV HOGE BELGIUM ORAL LIQUID 1.0X100.0 G 7/1/2005 GMP EXPIRED NONE
DP/4476 MAUW LIMITED 50S NE MAUW-HOGE MUW ORDINARY BOTTLE ON 03-02-19
900, 2370, SOLUBLE FOR NBL (Large
ARENDONK POWDERS Volume
Parenteral
Injections, Small
Volume
Parenteral
190 NDA/MAL/V VMD NV ERAM UGANDA ALBEVETO- ALBENDAZO 100MG/ML VMD NV-HOGE BELGIUM ORAL LIQUID 1.0X100.0 7/1/2000 GMP EXPIRED NONE
DP/5673 LIMITED 10 LE MAUW 900-B2370, ORDINARY ML ON 03-02-19
ARENDOK SUSPENSION BOTTLE,1.0 FOR NBL (Large
S X500.0 ML Volume
BOTTLE,1.0 Parenteral
X1.0 L Injections, Small
BOTTLE Volume
Parenteral
191 NDA/MAL/V VMD NV ERAM UGANDA DIAZIPRIM SULPHADIAZ 400 MG + VMD NV HOGE BELGIUM ORAL LIQUID 1.0X100.0 G 7/1/2000 GMP EXPIRED NONE
DP/5676 LIMITED 48% INE + 80 MG MAUW-HOGE MUW ORDINARY SACHET ON 03-02-19
TRIMETHOP 900, 2370, SOLUBLE FOR NBL (Large
RIM ARENDONK POWDERS Volume
Parenteral
Injections, Small
Volume
Parenteral
192 NDA/MAL/V VMD NV HOGE ERAM UGANDA DIMINAVETO DIMINAZEN 1.05G/1.31 VMD NV HOGE BELGIUM NON- 1.0X2.36 G 7/1/1999 GMP EXPIRED NONE
DP/5693 MAUW LIMITED E/ANTIPYRI G MAUW-HOGE MUW HUMAN USE SACHET,1.0 ON 03-02-19
NE 900, 2370, SOLUBLE X23.6 G FOR NBL (Large
ARENDONK POWDERS SACHET Volume
Parenteral
Injections, Small
Volume
Parenteral
193 NDA/MAL/V VMD NV HOGE ERAM UGANDA VMD MULTI- MULTI- VMD NV HOGE BELGIUM ORAL LIQUID 1.0X100.0 G 7/1/2001 GMP EXPIRED NONE
DP/5697 MAUW LIMITED OLIGOVIT INGREDIENT INGREDIEN MAUW--HOGE MUW ORDINARY SACHET ON 03-02-19
PLUS T 900-B2370, SOLUBLE FOR NBL (Large
ARENDONK POWDERS Volume
Parenteral
Injections, Small
Volume
Parenteral
194 NDA/MAL/V VMD NV ERAM UGANDA VMD MULTI- MULTI- VMD NV HOGE BELGIUM ORAL LIQUID 1.0X100.0 G 7/1/2001 GMP EXPIRED NONE
DP/5699 LIMITED SUPERVITAM VITAMIN INGREDIEN MAUW-B2370, ORDINARY SACHET ON 03-02-19
INS POWDER T ARENDOK SOLUBLE FOR NBL (Large
POWDERS Volume
Parenteral
Injections, Small
Volume
Parenteral
195 NDA/MAL/V VMD NV ERAM UGANDA OXYVETO 50 OXYTETRAC 500MG/G VMD NV-HOGE BELGIUM ORAL LIQUID 1.0X100.0 G 7/1/2000 GMP EXPIRED NONE
DP/5778 LIMITED S POWDER YCLINE HCL MAUW 900-B2370, ORDINARY SACHET,1.0 ON 03-02-19
ARENDOK SOLUBLE X250.0 G FOR NBL (Large
POWDERS SACHET,1.0 Volume
X500.0 G Parenteral
SACHET,1.0 Injections, Small
X1000.0 G Volume
SACHET Parenteral
196 NDA/MAL/V VMD NV ERAM UGANDA AMINOVIT MULTIVITA MULTI- VMD NV HOGE BELGIUM ORAL LIQUID 1.0X100.0 G 7/1/2000 GMP EXPIRED NONE
DP/5785 LIMITED POWDER MIN INGREDIEN MAUW-B2370, ORDINARY SACHET ON 03-02-19
T ARENDOK SOLUBLE FOR NBL (Large
POWDERS Volume
Parenteral
Injections, Small
Volume
Parenteral
197 NDA/MAL/V VMD NV HOGE ERAM UGANDA FLUMEQ-50- FLUMEQUIN 500MG/G VMD NV HOGE BELGIUM ORAL SOLID 1.0X100.0 G 7/1/2005 GMP EXPIRED NONE
DP/5794 MAUW LIMITED S E MAUW--HOGE MUW ORDINARY SACHET ON 03-02-19
900-B2370, POWDERS FOR NBL (Large
ARENDONK Volume
Parenteral
Injections, Small
Volume
Parenteral
198 NDA/MAL/V VMD NV ERAM UGANDA AMPROLIUM- AMPROLIU 200MG/G VMD NV-HOGE BELGIUM ORAL LIQUID 1.0X100.0 G 7/1/2000 GMP EXPIRED NONE
DP/5813 LIMITED 20S M MAUW 900-B2370, ORDINARY SACHET ON 03-02-19
HYDROCHL ARENDOK SOLUBLE FOR NBL (Large
ORIDE POWDERS Volume
Parenteral
Injections, Small
Volume
Parenteral
199 NDA/MAL/V VMD NV ERAM UGANDA GENTAVETO - GENTAMYCI 50MG/ML VMD NV-HOGE BELGIUM PARENTERAL 1.0X100.0 7/1/1998 GMP EXPIRED NONE
DP/5826 LIMITED 5 N SULPHATE MAUW 900-B2370, ORDINARY ML BOTTLE ON 03-02-19
ARENDOK VIALS FOR NBL (Large
Volume
Parenteral
Injections, Small
Volume
Parenteral
200 NDA/MAL/V VMD NV HOGE ERAM UGANDA COLIVETO- COLISTINE 4.8 VMD NV HOGE BELGIUM ORAL LIQUID 1.0X100.0 G 7/1/2005 GMP EXPIRED NONE
DP/6010 MAUW LIMITED 4800 SULPHATE MILLION MAUW-HOGE MUW ORDINARY CONTAINER ON 03-02-19
I.U/G 900, 2370, SOLUBLE FOR NBL (Large
ARENDONK POWDERS Volume
Parenteral
Injections, Small
Volume
Parenteral
201 NDA/MAL/H WOCKHARDT STAR KEFSTAR CEFUROXIM 125MG/5M WOCKHARDT LIMITED- INDIA ORAL LIQUID 1.0X50.0 7/1/2004 GMP EXPIRED NONE
DP/1586 LTD PHARMACEUTICA E L B-15/2 MIDC, WALUJ, ORDINARY ML BOTTLE ON 2012-12-14
LS LTD AURANGABAD DRY FOR Oral Dry
431136, SUSPENSION Powders for
MAHARASHTRA S/SYRUPS/DR reconstitution
STATE, INDIA OPS (BL/Cephalospori
ns), SVP
Powders, Tablets
202 NDA/MAL/H WOCKHARDT STAR KEFSTAR CEFUROXIM 750MG/10 WOCKHARDT LIMITED- INDIA PARENTERAL 1.0X10.0 7/1/2005 GMP EXPIRED NONE
DP/2023 LTD PHARMACEUTICA E ML VIAL B-15/2 MIDC, WALUJ, ORDINARY ML VIAL ON 2012-12-14
LS LTD AURANGABAD DRY VIALS FOR Oral Dry
431136, Powders for
MAHARASHTRA reconstitution
STATE, INDIA (BL/Cephalospori
ns), SVP
Powders, Tablets
203 NDA/MAL/H WOCKHARDT STAR POWERCEF CEFTRIAXO 1GM WOCKHARDT LIMITED- INDIA PARENTERAL 1.0X1.0 G 7/1/2001 GMP EXPIRED Zeiss
DP/3954 LTD PHARMACEUTICA 1GM NE SODIUM B-15/2 MIDC, WALUJ, ORDINARY VIAL ON 2012-12-14 Pharmaceuticals
LS LTD INJECTION AURANGABAD DRY VIALS FOR Oral Dry Pvt. Limited-Plot
431136, Powders for No. 72, EPIP I,
MAHARASHTRA reconstitution Jharmajiri, Baddi
STATE, INDIA (BL/Cephalospori (HP), India
ns), SVP
Powders, Tablets
204 NDA/MAL/H ZAHRAVI UNEED GLOBAL ADVIFEN IBUPROFEN 400MG ZAHRAVI IRAN ORAL SOLID 1.0X10.0X5. 7/1/2012 FAILED GMP ON NONE
DP/4761 PHARMACEUTIC GROUP LIMITED PHARMACEUTICAL ORDINARY 0 CAPSULE 2016-08-24 FOR
AL COMPANY COMPANY-19TH KM COMBINATIO BLISTER • SVP Solutions •
TABRIZ TEHRAN ROAD N PACK Hard Gelatin
OPPOSITE TO THE CAPSULES capsules • Soft
AGRICULTURE Gelatin •
TRAINING CENTER Tablets
TABRIZ
205 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA HYDROCORTI HYDROCOR 100MG/VI ZHEJIANG RUIXIN CHINA PARENTERAL 1.0X10.0X1 7/1/2007 FAILED GMP ON NONE
DP/1678 (U) LIMITED (U) LIMITED SONE TISONE AL PHARMACEUTICAL ORDINARY 00.0 MG 8TH,9TH AND
SODIUM SODIUM CO. LTD-KAIFA ROAD, DRY VIALS VIAL 12TH Aug 2019
SUCCINATE SUCCINATE LISHUI, ZHEJIANG P.R for
OF CHINA NBL(Tablets,Cap
sules and SVP
liquids),Hormon
es(SVPs),Cephal
206 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA OXYTOCIN OXYTOCIN 10I.U/ML ZHEJIANG RUIXIN CHINA PARENTERAL 1.0X10.0X1. 7/1/2007 FAILED GMP ON NONE
DP/1905 (U) LIMITED (U) LIMITED INJECTION PHARMACEUTICAL ORDINARY 0 ML 8TH,9TH AND
CO. LTD-KAIFA ROAD, AMPOULES AMPOULE,1 12TH Aug 2019
LISHUI, ZHEJIANG P.R .0X100.0X1. for
OF CHINA 0 ML NBL(Tablets,Cap
AMPOULE sules and SVP
liquids),Hormon
es(SVPs),Cephal
207 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA PARACETAM PARACETAM 500MG ZHEJIANG RUIXIN CHINA ORAL SOLID 1.0X100.0X 7/1/2002 FAILED GMP ON NONE
DP/2274 (UK) LTD (U) LIMITED OL TABLETS OL PHARMACEUTICAL ORDINARY 10.0 8TH,9TH AND
500MG CO., LTD--KAITEE TABLETS TABLET 12TH Aug 2019
ROAD, TIANNING CONTAINER for
INDUSTRIAL ZONE, ,1.0X10.0X1 NBL(Tablets,Cap
LISHUI, ZHEJIANG, 0.0 TABLET sules and SVP
P.R.CHINA BLISTER,1.0 liquids),Hormon
X1000.0 es(SVPs),Cephal
208 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA DICLOFENAC DICLOFENA 25MG/ML ZHEJIANG RUIXIN CHINA PARENTERAL 1.0X10.0X1 7/1/2009 FAILED GMP ON NONE
DP/2512 (U) LIMITED (U) LIMITED SODIUM C SODIUM PHARMACEUTICAL ORDINARY 0.0X3.0 ML 8TH,9TH AND
INJECTABLE CO. LTD-KAIFA ROAD, AMPOULES AMPOULE 12TH Aug 2019
SOLUTION LISHUI, ZHEJIANG P.R for
OF CHINA NBL(Tablets,Cap
sules and SVP
liquids),Hormon
es(SVPs),Cephal
209 NDA/MAL/H UNEED GLOBAL ASTRA PHARMA CHLORAMPH CHLORAMP 250MG ZHEJIANG RUIXIN CHINA ORAL SOLID 1.0X1000.0 7/1/2002 FAILED GMP ON NONE
DP/2724 GROUP LIMITED (U) LIMITED ENICOL HENICOL PHARMACEUTICAL ORDINARY CAPSULE 8TH,9TH AND
250MG CO., LTD--KAITEE CAPSULES CONTAINER 12TH Aug 2019
CAPSULES BP ROAD, TIANNING ,1.0X10.0X1 for
INDUSTRIAL ZONE, 0.0 NBL(Tablets,Cap
LISHUI, ZHEJIANG, CAPSULE sules and SVP
P.R.CHINA BLISTER,1.0 liquids),Hormon
X100.0X10. es(SVPs),Cephal
210 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA QUININE QUININE 600MG/2M ZHEJIANG RUIXIN CHINA PARENTERAL 1.0X10.0X1 7/1/2008 FAILED GMP ON NONE
DP/2726 (U) LIMITED (U) LIMITED INJECTION DIHYDROCH L PHARMACEUTICAL ORDINARY 0.0X2.0 ML 8TH,9TH AND
LORIDE CO., LTD-KAIFA ROAD, AMPOULES AMPOULE,1 12TH Aug 2019
TIANNING .0X10.0X2.0 for
INDUSTRIAL ZONE, ML NBL(Tablets,Cap
LISHUI, ZHEJIANG, AMPOULE sules and SVP
P.R.CHINA liquids),Hormon
es(SVPs),Cephal
211 NDA/MAL/H BEIJING HOLLEY SUPER DUO- DIHYDROAR 40MG + ZHEIJIANG HOLLEY CHINA ORAL SOLID 1.0X1.0X9.0 7/1/2005 GMP EXPIRED NONE
DP/2743 COTEC PHARMA PHARMACEUTICA COTECXIN TEMISININ + 320MG NANHU ORDINARY TABLET ON THE
CHINA LS LIMITED PIPERAQUIN PHARMACEUTICAL FILM- BLISTER,1.0 5/5/2018 FOR
E CO. LTD.- COATED X1.0X4.0 LINES • Oral
PHOSPHATE NO.205,YUNHAI TABLETS TABLET Tablets • Oral
ROAD, JIAXING BLISTER,1.0 Dry Powder in
DEVELOPMENT ZONE, X30.0X9.0 sachets. • Oral
JIANXING CITY, TABLET Hard gelatin
212 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA TETRACYCLI TETRACYCLI 250MG ZHEJIANG RUIXIN CHINA ORAL SOLID 1.0X1000.0 7/1/2002 FAILED GMP ON NONE
DP/2926 (UK) LTD (U) LIMITED NE 250MG NE PHARMACEUTICAL ORDINARY CAPSULE 8TH,9TH AND
CAPSULES BP CO., LTD--KAITEE CAPSULES CONTAINER 12TH Aug 2019
ROAD, TIANNING ,1.0X10.0X1 for
INDUSTRIAL ZONE, 0.0 NBL(Tablets,Cap
LISHUI, ZHEJIANG, CAPSULE sules and SVP
P.R.CHINA BLISTER,1.0 liquids),Hormon
X100.0X10. es(SVPs),Cephal
213 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA LIDOCAINE LIDOCAINE 20MG/ML ZHEJIANG RUIXIN CHINA PARENTERAL 1.0X25.0X2 7/1/2008 FAILED GMP ON NONE
DP/3017 (U) LIMITED (U) LIMITED INJECTION HYDROCHL PHARMACEUTICALS ORDINARY 0.0 ML VIAL 8TH,9TH AND
ORIDE CO LTD-KAIFA ROAD VIALS 12TH Aug 2019
TIANNING IDOUS for
ZONE LISHUI CITY NBL(Tablets,Cap
sules and SVP
liquids),Hormon
es(SVPs),Cephal
214 NDA/MAL/H ROYAL PHARMA SINO AFRICA DICLOFENAC DICLOFENA 75MG/3ML ZHEJIANG TIANFENG CHINA PARENTERAL 1.0X10.0X1 7/1/2008 GMP EXPIRED KIVI PHARM CO.
DP/3018 2011 LIMITED MEDICINES & SODIUM C SODIUM PHARMACEUTICAL ORDINARY 0.0X3.0 ML ON 2015-10-07 LTD-DONGSHAN
HEALTH LTD FACTORY-NO.518 DA AMPOULES AMPOULE FOR NBL LVP HIGH TECH
Solutions SVP INDUSTRIAL
Solutions DEVELOPMENT
ZONE,XUANHUA
,ZHANGJIAKOU
CITY,HEBEI
215 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA AMINOPHYL AMINOPHYL 25MG/ML ZHEJIANG RUIXIN CHINA PARENTERAL 1.0X5.0X10. 7/1/2009 FAILED GMP ON NONE
DP/3185 (U) LIMITED (U) LIMITED LINE LINE PHARMACEUTICAL ORDINARY 0X10.0 ML 8TH,9TH AND
INJECTION CO. LTD-KAIFA ROAD, AMPOULES AMPOULE,1 12TH Aug 2019
LISHUI, ZHEJIANG P.R .0X10.0X10. for
OF CHINA 0 ML NBL(Tablets,Cap
AMPOULE sules and SVP
liquids),Hormon
es(SVPs),Cephal
216 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA ATROPINE ATROPINE 1MG/ML ZHEJIANG RUIXIN CHINA PARENTERAL 1.0X100.0X 7/1/2009 FAILED GMP ON NONE
DP/3564 (U) LIMITED (U) LIMITED INJECTION SULPHATE PHARMACEUTICAL ORDINARY 1.0 ML 8TH,9TH AND
CO. LTD-KAIFA ROAD, AMPOULES AMPOULE,1 12TH Aug 2019
LISHUI, ZHEJIANG P.R .0X10.0X1.0 for
OF CHINA ML NBL(Tablets,Cap
AMPOULE sules and SVP
liquids),Hormon
es(SVPs),Cephal
217 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA METOCLOPR METOCLOP 5MG/ML ZHEJIANG RUIXIN CHINA PARENTERAL 1.0X10.0X2. 7/1/2009 FAILED GMP ON NONE
DP/3577 (U) LTD (U) LIMITED AMIDE RAMIDE PHARMACEUTICAL ORDINARY 0 ML 8TH,9TH AND
CO. LTD-KAIFA ROAD, AMPOULES AMPOULE,1 12TH Aug 2019
LISHUI, ZHEJIANG P.R .0X10.0X10. for
OF CHINA 0X2.0 ML NBL(Tablets,Cap
AMPOULE sules and SVP
liquids),Hormon
es(SVPs),Cephal
218 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA CHLORPROM CHLORPRO 25MG/ML ZHEJIANG RUIXIN CHINA PARENTERAL 1.0X10.0X1 7/1/2009 FAILED GMP ON NONE
DP/3599 LTD (U) LIMITED AZINE MAZINE PHARMACEUTICAL ORDINARY 0.0X2.0 ML 8TH,9TH AND
INJECTION CO. LTD-KAIFA ROAD, AMPOULES AMPOULE,1 12TH Aug 2019
LISHUI, ZHEJIANG P.R .0X10.0X2.0 for
OF CHINA ML NBL(Tablets,Cap
AMPOULE sules and SVP
liquids),Hormon
es(SVPs),Cephal
219 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA PROMETHAZI PROMETHA 25MG/ML ZHEJIANG RUIXIN CHINA PARENTERAL 1.0X10.0X1 7/1/2010 FAILED GMP ON NONE
DP/3673 (U) LIMITED (U) LIMITED NE ZINE HCL PHARMACEUTICAL ORDINARY 0.0X2.0 ML 8TH,9TH AND
INJECTABLE CO. LTD-KAIFA ROAD, AMPOULES AMPOULE, 12TH Aug 2019
SOLUTION LISHUI, ZHEJIANG P.R 1.0X10.0X2. for
OF CHINA 0 ML NBL(Tablets,Cap
AMPOULE sules and SVP
liquids),Hormon
es(SVPs),Cephal
220 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA VITAMIN B VITAMIN B1 10MG + ZHEJIANG RUIXIN CHINA PARENTERAL 1.0X10.0X2. 7/1/2008 FAILED GMP ON NONE
DP/4340 (U) LTD (U) LIMITED COMPLEX + VITAMIN 1.37MG + PHARMACEUTICAL ORDINARY 0 ML 8TH,9TH AND
B2 + 15MG + CO., LTD--KAITEE AMPOULES AMPOULE,1 12TH Aug 2019
SODIUM 1MG + ROAD, TIANNING .0X10.0X10. for
NICOTINAM 0.5MG INDUSTRIAL ZONE, 0X2.0 ML NBL(Tablets,Cap
IDE + LISHUI, ZHEJIANG, AMPOULE sules and SVP
VITAMIN B6 P.R.CHINA liquids),Hormon
+ D- es(SVPs),Cephal
221 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA GENTAMICIN GENTAMYCI 80MG/2ML ZHEJIANG RUIXIN CHINA PARENTERAL 1.0X10.0X1 7/1/2007 FAILED GMP ON NONE
DP/5001 (U) LIMITED (U) LIMITED INJECTION N PHARMACEUTICAL ORDINARY 0.0X2.0 ML 8TH,9TH AND
CO. LTD-KAIFA ROAD, AMPOULES AMPOULE 12TH Aug 2019
LISHUI, ZHEJIANG P.R for
OF CHINA NBL(Tablets,Cap
sules and SVP
liquids),Hormon
es(SVPs),Cephal
222 NDA/MAL/H ROYAL GROUP HARLEYS GENTAMICIN GENTAMYCI 40MG/ML ZHEJIANG TIANTENG CHINA PARENTERAL 1.0X100.0X 7/1/2010 GMP EXPIRED NONE
DP/5012 UGANDA INJECTION N SULPHATE PHARMACEUTICALS ORDINARY 2.0 ML ON 19/08/2019
LIMITED FACTORY-518 AMPOULES AMPOULE FOR NBL •
DAXIANG ROAD, Tablets (Coated
HUZHOU ZHEJIANG, and Uncoated) •
CHINA GRAND Hard Gelatin
PHARMACEUTICAL Capsules • SVP
(CHINA) CO. LTD-- Liquid ampoule
223 NDA/MAL/H ADCOCK UHMG GOODLIFE LOTEM PARACETAM 125MG + ADCOCK INGRAM SOUTH ORAL LIQUID 1.0X1.0X10 11/26/2019 GMP EXPIRED NONE
DP/8141 INGRAM PHARMACY SUSPENSION OL + 100MG / HEALTHCARE (PTY) AFRICA ORDINARY 0.0 ML ON 04/10/2019
HEALTH CARE IBUPROFEN 5ML LTD, CLAYVILLE- SUSPENSION BOTTLE FOR LIQUIDS
(PTY) LTD CORNER AXLE DRIVE S FOR INTERNAL
AND BARSTEEN ROAD USE
CLAYVILLE OLIFANTS,
SOUTH AFRICA
224 NDA/MAL/H GALPHA AIVEEN (U) CLANOXY 1.2 AMOXICILLI 1000 MG + GALPHA INDIA PARENTERAL 1.0X1.0 ML 7/1/2010 GMP expired on NONE
DP/0827 LABORATORIES LIMITED N+ 200 MG LABORATORIES LTD- ORDINARY VIAL 29-11-2019 FOR
LTD CLAVULANA AT: ALKEM DRY VIALS 1*20ML Hard Gelatin
TE LABORATORIES LTD VIAL OF WFI Capsules (NBL,
PLOT 167/2 Cephalosporin &
MAHATMA UDYOG Penicillin)
NAGAR AMALIYA Tablets. (NBL &
DAMAN 396210 Cephalosporin)
225 NDA/MAL/H : ALKEM ABACUS PHARMA CLAVAM AMOXICILLI 156.25MG ALKEM INDIA ORAL LIQUID 1.0X100.0 7/1/2008 GMP expired on NONE
DP/1568 LABORATORIES (AFRICA) LIMITED N AND LABORATORIES LTD- ORDINARY ML BOTTLE 29-11-2019 FOR
LIMITED√ CLAVULANA PLOT 167/1 VILLABE DRY Hard Gelatin
TE DAHBEL AMALIYA SUSPENSION Capsules (NBL,
POTASSIUM DAMAN 396210 S/SYRUPS/DR Cephalosporin &
OPS Penicillin)
Tablets. (NBL &
Cephalosporin)
226 NDA/MAL/H : ALKEM ABACUS PHARMA CLAVAM AMOXICILLI 1000MG ALKEMS INDIA PARENTERAL 1.0X1.0 7/1/2005 GMP expired on ALKEM
DP/1632 LABORATORIES (AFRICA) LIMITED 1.2G N SODIUM + +200MG LABORATORIES ORDINARY VIAL 29-11-2019 FOR LABORATORIES
LIMITED√ CLAVULANA LIMITED-PLOT 167/1 DRY VIALS CARTON + Hard Gelatin LTD .,.-VILLAGE
TE MAHATMA GHANDHI, 1 AMPOULE Capsules (NBL, THANA BADDI
POTASSIUM UDYOG NAGAR, OF WFI Cephalosporin & DIST-SOLAN
DABHEL, AMALIYA Penicillin) TEHSIL
DAMAN- 396 210 Tablets. (NBL & NALAGARH
UTTARANCHAL, INDIA. Cephalosporin) HIMACHAL
227 NDA/MAL/H : ALKEM ABACUS PHARMA CLAVAM BID AMOXICILLI 200 MG + ALKEM INDIA ORAL LIQUID 1.0X100.0 7/1/2010 GMP expired on NONE
DP/2602 LABORATORIES (AFRICA) LIMITED N+ 28.5 MG/ 5 LABORATORIES LTD-- ORDINARY ML BOTTLE 29-11-2019 FOR
LIMITED√ CLAVULANI ML PLOT NO. 167/1, DRY Hard Gelatin
C ACID MAHATMA GANDHI SUSPENSION Capsules (NBL,
UDYONG NAGAR, S/SYRUPS/DR Cephalosporin &
AMALIYA, DABHEL, OPS Penicillin)
DAMAN,396210 Tablets. (NBL &
INDIA. Cephalosporin)
228 NDA/MAL/H ALKEM ABACUS PHARMA CLAVAM 375 AMOXICILLI 250MG + ALKEM INDIA ORAL SOLID 1.0X2.0X10. 7/1/2005 GMP expired on NONE
DP/4556 LABORATORIES (AFRICA) LIMITED N 125MG LABORATORIES LTD-- ORDINARY 0 TABLET 29-11-2019 FOR
LIMITED TRIHYDRATE 167/1, VILLAGE FILM- STRIP Hard Gelatin
+ DABHEL, AMALIYA COATED Capsules (NBL,
CLAVULANA DAMAN-396210, TABLETS Cephalosporin &
TE INDIA Penicillin)
POTASSIUM Tablets. (NBL &
Cephalosporin)
229 NDA/MAL/H ALKEM ABACUS PHARMA CLAVAM 625 AMOXICILLI 500MG + ALKEM INDIA ORAL SOLID 1.0X2.0X10. 7/1/2005 GMP expired on NONE
DP/4568 LABORATORIES (AFRICA) LIMITED N 125MG LABORATORIES LTD-- ORDINARY 0 TABLET 29-11-2019 FOR
LIMITED TRIHYDRATE 167/1, VILLAGE FILM- STRIP Hard Gelatin
+ DABHEL, AMALIYA COATED Capsules (NBL,
CLAVULANA DAMAN-396210, TABLETS Cephalosporin &
TE INDIA Penicillin)
POTASSIUM Tablets. (NBL &
Cephalosporin)
230 NDA/MAL/H ALKEM ABACUS PHARMA CLAVAM AMOXICILLI 875MG + ALKEM INDIA ORAL SOLID 1.0X1.0X10. 7/1/2005 GMP expired on NONE
DP/4581 LABORATORIES (AFRICA) LIMITED 1000 N 125MG LABORATORIES LTD-- ORDINARY 0 TABLET 29-11-2019 FOR
LIMITED TRIHYDRATE 167/1, VILLAGE FILM- STRIP Hard Gelatin
+ DABHEL, AMALIYA COATED Capsules (NBL,
CLAVULANA DAMAN-396210, TABLETS Cephalosporin &
TE INDIA Penicillin)
POTASSIUM Tablets. (NBL &
Cephalosporin)
231 NDA/MAL/H ALKEM ABACUS PHARMA PIPZO PIPERACILLI 4.5G ALKEM INDIA PARENTERAL 1.0X1.0X4.5 7/1/2014 GMP expired on ALKEM LABS
DP/4745 LABORATORIES (AFRICA) LIMITED N+ LABORATORIES LTD-- ORDINARY G VIAL + 29-11-2019 FOR LTD.-VILLAGE
LIMITED TAZOBACTA PLOT NO. 167/1, DRY VIALS STERILIZED Hard Gelatin THANA, BADDI,
M MAHATMA GANDHI WATER FOR Capsules (NBL, THE NALAGARH,
UDYONG NAGAR, INJECTION Cephalosporin & DIST SOLAN (HP)
AMALIYA, DABHEL, Penicillin) 173205
DAMAN,396210 Tablets. (NBL &
INDIA. Cephalosporin)
232 NDA/MAL/H CACHET ASTRA PHARMA ACINET AMOXICILLI 500 MG + ALKEM INDIA ORAL SOLID 1.0X10.0 7/1/2016 GMP expired on NONE
DP/6228 PHAMACUITICA (U) LIMITED N+ 125 MG LABORATORIES LTD-- ORDINARY TABLET 29-11-2019 FOR
LS PVT LTD POTASSIUM PLOT NO. 167/1, FILM- BLISTER Hard Gelatin
CLAVULANA MAHATMA GANDHI COATED Capsules (NBL,
TE UDYONG NAGAR, TABLETS Cephalosporin &
AMALIYA, DABHEL, Penicillin)
DAMAN,396210 Tablets. (NBL &
INDIA. Cephalosporin)
233 NDA/MAL/H CACHET ASTRA PHARMA CLAVACE AMOXICILLI 875MG + ALKEM INDIA ORAL SOLID 1.0X1.0X10. 3/28/2018 GMP expired on NONE
DP/6322 PHARMACEUTIC (U) LIMITED 1000 MG N 125MG LABORATORIES LTD-- ORDINARY 0 TABLET 29-11-2019 FOR
ALS PVT TRIHYDRATE PLOT NO. 167/1, FILM- BLISTER Hard Gelatin
LIMITED + MAHATMA GANDHI COATED Capsules (NBL,
CLAVULANA UDYONG NAGAR, TABLETS Cephalosporin &
TE AMALIYA, DABHEL, Penicillin)
POTASSIUM DAMAN,396210 Tablets. (NBL &
INDIA. Cephalosporin)
234 NDA/MAL/H PRIDE ROYAL PHARMA AUGRPRO AMOXICILLI 500MG + ALKEM LABS LTD- INDIA ORAL SOLID 1.0X2.0X10. 5/29/2019 GMP expired on NONE
DP/6398 INTERNATIONAL 2011 LIMITED 625 N 125MG 167/1, MAHATMA ORDINARY 0 TABLET 29-11-2019 FOR
. TRIHYDRATE GANDHI UDUOG, TABLETS BLISTER Hard Gelatin
+ NAGAR, DABRIEL, Capsules (NBL,
CLAVULANA AMALIYA, DAMAN Cephalosporin &
TE 396210 9UT) Penicillin)
POTASSIUM Tablets. (NBL &
Cephalosporin)
235 NDA/MAL/H ALKEM ABACUS PHARMA NEUROKEM PREGABALI 150MG ALKEM INDIA ORAL SOLID 1.0X10.0 1/31/2018 GMP expired on NONE
DP/6496 LABORATORIES (AFRICA) LIMITED 150 N LABORATORIES LTD-- ORDINARY CAPSULE 29-11-2019 FOR
LIMITED 167/2, MAHATMA CAPSULES BLISTER Hard Gelatin
GANDHI UDYOG Capsules (NBL,
NAGAR DABHEL, Cephalosporin &
AMALIYA, Penicillin)
DAMAN(UT) 396 210 Tablets. (NBL &
INDIA Cephalosporin)
236 NDA/MAL/H CACHET ASTRA PHARMA CLAVACE AMOXYCILLI 200MG + ALKEM LABS LTD- INDIA ORAL LIQUID 1.0X100.0 8/28/2019 GMP expired on NONE
DP/6578 PHARMACEUTIC (U) LIMITED N 28.5MG 167/1, MAHATMA ORDINARY ML BOTTLE 29-11-2019 FOR
ALS PRIVATE TRIHYDRATE PER 5ML GANDHI UDUOG, DRY Hard Gelatin
LIMITED + NAGAR, DABRIEL, SUSPENSION Capsules (NBL,
CLAVULANA AMALIYA, DAMAN S/SYRUPS/DR Cephalosporin &
TE 396210 9UT) OPS Penicillin)
POTASSIUM Tablets. (NBL &
Cephalosporin)
237 NDA/MAL/H ALKEM ABACUS PHARMA FUNGIKEM ITRACONAZ 100MG ALKEM LABS LTD- INDIA ORAL SOLID 1.0X1.0X14. 8/28/2019 GMP expired on NONE
DP/7438 LABORATORIES (AFRICA) LIMITED OLE 167/1, MAHATMA ORDINARY 0 CAPSULE 29-11-2019 FOR
LIMITED GANDHI UDUOG, CAPSULES BLISTER Hard Gelatin
NAGAR, DABRIEL, Capsules (NBL,
AMALIYA, DAMAN Cephalosporin &
396210 9UT) Penicillin)
Tablets. (NBL &
Cephalosporin)
238 NDA/MAL/V BAODING BD LEVA & LEVAMISOL 30MG/ML BAODING SUNLIGHT CHINA ORAL LIQUID 1.0X1.0 ML 7/1/2017 GMP expired on NONE
DP/7059 SUNLIGHT HERB PHARMACEUTICA CLOZA E + HERB MEDICAMENT ORDINARY BOTTLE,1.0 12-08-2019 for
MEDICAMENT LS LTD HYDROCHL 60MG/ML CO., LTD-NO.76 SUSPENSION X500.0 ML Non Beta Lactam
CO., LTD ORIDE + NORTH TUANJIE ROAD S BOTTLE 1. Tablets (and
OXYCLOZAN QINGYUAN, BAODING granules in
IDE CITY sachets) 2. LVP
solution - Vials 3.
SVP solutions -
239 NDA/MAL/V BAODING BD IVER PLUS IVERMECTIN 10MG/ML BAODING SUNLIGHT CHINA PARENTERAL 1.0X100.0 7/1/2017 GMP expired on NONE
DP/7060 SUNLIGHT HERB PHARMACEUTICA + +100MG/M HERB MEDICAMENT ORDINARY S ML VIAL 12-08-2019 for
MEDICAMENT LS LTD CLORSULON L CO.LTD-NO.76 NORTH C VIALS Non Beta Lactam
CO., LTD TUANJIE ROAD 1. Tablets (and
QINGYUAN BAODING granules in
CITY HEBEI PROVINCE sachets) 2. LVP
solution - Vials 3.
SVP solutions -
240 NDA/MAL/V BAODING BD OXY-100 OXYTETRAC 100MG/ML BAODING SUNLIGHT CHINA PARENTERAL 1.0X100.0 7/1/2017 GMP expired on NONE
DP/7061 SUNLIGHT HERB PHARMACEUTICA YCLINE HERB MEDICAMENT ORDINARY ML VIAL 12-08-2019 for
MEDICAMENT LS LTD CO., LTD-NO. 76 VIALS Non Beta Lactam
CO., LTD NORTH 1. Tablets (and
TUANJIE ROAD granules in
QINGYUAN, BAODING sachets) 2. LVP
CITY, HEBEI solution - Vials 3.
PROVINCE, SVP solutions -
241 NDA/MAL/V BAODING BD ALBEN-100 ALBENDAZO 10%W/V BAODING SUNLIGHT CHINA ORAL LIQUID 1.0X120.0 7/1/2017 GMP expired on NONE
DP/7654 SUNLIGHT HERB PHARMACEUTICA LE HERB MEDICAMENT ORDINARY ML 12-08-2019 for
MEDICAMENT LS LTD CO.LTD-NO.76 NORTH SUSPENSION CONTAINER Non Beta Lactam
CO., LTD TUANJIE ROAD S ,1.0X5000.0 1. Tablets (and
QINGYUAN BAODING ML granules in
CITY HEBEI PROVINCE CONTAINER sachets) 2. LVP
,1.0X1000.0 solution - Vials 3.
ML SVP solutions -
242 NDA/MAL/V BAODING BD ALBEN-25 ALBENDAZO 2.5%W/V BAODING SUNLIGHT CHINA ORAL LIQUID 1.0X500.0 7/1/2017 GMP expired on NONE
DP/7658 SUNLIGHT HERB PHARMACEUTICA LE HERB MEDICAMENT ORDINARY ML 12-08-2019 for
MEDICAMENT LS LTD CO., LTD-NO. 76 SUSPENSION CONTAINER Non Beta Lactam
CO., LTD NORTH S ,1.0X120.0 1. Tablets (and
TUANJIE ROAD ML granules in
QINGYUAN, BAODING CONTAINER sachets) 2. LVP
CITY, HEBEI ,1.0X5000.0 solution - Vials 3.
PROVINCE, ML SVP solutions -
243 NDA/MAL/V BAODING BD ALBEN & ALBENDAZO 2.5%W/V + BAODING SUNLIGHT CHINA ORAL LIQUID 1.0X1.0 ML 7/1/2017 GMP expired on NONE
DP/7661 SUNLIGHT HERB PHARMACEUTICA IVER ORAL LE+ 0.1%W/V HERB MEDICAMENT ORDINARY CONTAINER 12-08-2019 for
MEDICAMENT LS LTD IVERMECTIN CO., LTD-NO. 76 SUSPENSION Non Beta Lactam
CO., LTD NORTH S 1. Tablets (and
TUANJIE ROAD granules in
QINGYUAN, BAODING sachets) 2. LVP
CITY, HEBEI solution - Vials 3.
PROVINCE, SVP solutions -
244 NDA/MAL/V BAODING BD PEN-STREP PENICILLIN 200,000 IU BAODING SUNLIGHT CHINA PARENTERAL 1.0X100.0 7/1/2017 GMP expired on NONE
DP/7697 SUNLIGHT HERB PHARMACEUTICA G PROCAINE + HERB MEDICAMENT ORDINARY ML VIAL 12-08-2019 for
MEDICAMENT LS LTD + 200MG/ML CO., LTD-NO. 76 VIALS Non Beta Lactam
CO., LTD DIHYROSTR NORTH 1. Tablets (and
EPTOMYCIN TUANJIE ROAD granules in
SULFATE QINGYUAN, BAODING sachets) 2. LVP
CITY, HEBEI solution - Vials 3.
PROVINCE, SVP solutions -
245 NDA/MAL/V BAODING BD MULTIVIT VITAMINS [ 3000I.U + BAODING SUNLIGHT CHINA PARENTERAL 1.0X100.0 7/1/2017 GMP expired on NONE
DP/8262 SUNLIGHT HERB PHARMACEUTICA A + D3 +E 2000I.U HERB MEDICAMENT ORDINARY ML VIAL 12-08-2019 for
MEDICAMENT LS LTD +B1 + B2 + +4MG + CO., LTD-NO. 76 VIALS Non Beta Lactam
CO.LTD B6 +B12 + C 10MG NORTH 1. Tablets (and
] + D- +1MG TUANJIE ROAD granules in
PANTHENOL +5MG QINGYUAN, BAODING sachets) 2. LVP
+ +10MCG + CITY, HEBEI solution - Vials 3.
NICOTINAM 1MG + PROVINCE, SVP solutions -
246 NDA/MAL/H BEXIMCO KIMSY MEDS LTD BEXITROL-F SALMETERO 25MCG+12 BEXIMCO BANGLADES TOPICAL 1.0X120.0 7/1/2015 GMP EXPIRED NONE
DP/0461 PHARMACEUTIC HFA 25/125 L 5MCG PHARMACEUTICALS H EXTERNAL METERED ON 2019-08-10
ALS LTD XINAFOATE LTD-TONGI- 1711, METERED- DOSE FOR • Tablets
+ GAZIPUR, DOSE CANNISTER (coated and
FLUTICASON BANGLADESH PRESSURISED uncoated) •
E AEROSOLS Capsules (hard
PROPIONAT gelatin) • Eye
E Drops (in three
247 NDA/MAL/H BEXIMCO KIMSY MEDS LTD DECOMIT 50 BECLOMETH 50MCG BEXIMCO BANGLADES TOPICAL 1.0X200.0 7/1/2015 GMP EXPIRED NONE
DP/0462 PHARMACEUTIC HFA ASONE PHARMACEUTICALS H EXTERNAL METERED ON 2019-08-10
ALS LTD LTD-TONGI- 1711, METERED- DOSE FOR • Tablets
GAZIPUR, DOSE CANNISTER (coated and
BANGLADESH PRESSURISED uncoated) •
AEROSOLS Capsules (hard
gelatin) • Eye
Drops (in three
248 NDA/MAL/H BEXIMCO KIMSY MEDS LTD DECOMIT BECLOMETH 200MCG BEXIMCO BANGLADES TOPICAL 1.0X200.0 7/1/2015 GMP EXPIRED NONE
DP/0465 PHARMACEUTIC 100 HFA ASONE PHARMACEUTICALS H EXTERNAL METERED ON 2019-08-10
ALS LTD DIPROPION LTD-TONGI- 1711, METERED- DOSE FOR • Tablets
ATE GAZIPUR, DOSE CANNISTER (coated and
BANGLADESH PRESSURISED uncoated) •
AEROSOLS Capsules (hard
gelatin) • Eye
Drops (in three
249 NDA/MAL/H BEXIMCO KIMSY MEDS LTD ALPHIN DS ALBENDAZO 400MG BEXIMCO BANGLADES ORAL SOLID 1.0X50.0 7/1/2015 GMP EXPIRED NONE
DP/0466 PHARMACEUTIC LE PHARMACEUTICALS H ORDINARY TABLET ON 2019-08-10
ALS LTD LTD-TONGI- 1711, CHEWABLE BLISTER,1.0 FOR • Tablets
GAZIPUR, TABLETS X50.0X1.0 (coated and
BANGLADESH TABLET uncoated) •
BLISTER Capsules (hard
gelatin) • Eye
Drops (in three
250 NDA/MAL/H BEXIMCO KIMSY MEDS LTD ZOLFIN ACECLOFEN 100MG BEXIMCO BANGLADES ORAL SOLID 1.0X15.0X1 7/1/2013 GMP EXPIRED NONE
DP/0492 PHARMACEUTIC AC PHARMACEUTICALS H ORDINARY 0.0 TABLET ON 2019-08-10
ALS LTD LTD-TONGI- 1711, FILM- BLISTER FOR • Tablets
GAZIPUR, COATED (coated and
BANGLADESH TABLETS uncoated) •
Capsules (hard
gelatin) • Eye
Drops (in three
251 NDA/MAL/H BEXIMCO KIMSY MEDS LTD INFORMET METFORMI 500MG BEXIMCO BANGLADES ORAL SOLID 1.0X10.0X1 7/1/2013 GMP EXPIRED NONE
DP/0494 PHARMACEUTIC 500 N PHARMACEUTICALS H ORDINARY 0.0 TABLET ON 2019-08-10
ALS LIMITED HYDROCHL LTD-TONGI- 1711, FILM- BLISTER FOR • Tablets
ORIDE GAZIPUR, COATED (coated and
BANGLADESH TABLETS uncoated) •
Capsules (hard
gelatin) • Eye
Drops (in three
252 NDA/MAL/H BEXIMCO KIMSY MEDS LTD EVO 500 LEVOFLOXA 500MG BEXIMCO BANGLADES ORAL SOLID 1.0X2.0X10. 7/1/2013 GMP EXPIRED NONE
DP/0498 PHARMACEUTIC CIN PHARMACEUTICALS H ORDINARY 0 TABLET ON 2019-08-10
ALS LTD LTD-TONGI- 1711, FILM- BLISTER FOR • Tablets
GAZIPUR, COATED (coated and
BANGLADESH TABLETS uncoated) •
Capsules (hard
gelatin) • Eye
Drops (in three
253 NDA/MAL/H BEXIMCO KIMSY MEDS LTD AZMASOL SALBUTAM 100MCG/A BEXIMCO BANGLADES TOPICAL 1.0X200.0 7/1/2015 GMP EXPIRED NONE
DP/5485 PHARMACEUTIC HFA OL CTUATION PHARMACEUTICALS H EXTERNAL METERED ON 2019-08-10
ALS LIMITED LTD-TONGI- 1711, METERED- DOSE FOR • Tablets
GAZIPUR, DOSE CANNISTER (coated and
BANGLADESH PRESSURISED uncoated) •
AEROSOLS Capsules (hard
gelatin) • Eye
Drops (in three
254 NDA/MAL/H BEXIMCO ABACUS PHARMA ODYCIN EYE MOXIFLOXA 5MG/ML BEXIMCO BANGLADES OPHTHALMI 1.0X1.0X5.0 5/30/2018 GMP EXPIRED NONE
DP/6366 PHARMACEUTIC (AFRICA) LIMITED DROPS CIN PHARMACEUTICALS H C DROPS ML VIAL ON 2019-08-10
ALS LIMITED. HYDROCHL LTD-126 KATHALDIA, FOR • Tablets
ORIDE AUCHPARA, TONGI- (coated and
1711, uncoated) •
GAZIPUR." Capsules (hard
gelatin) • Eye
Drops (in three
255 NDA/MAL/H IRAN MEDICAL UNEED GLOBAL LORAXONE CEFTRIAXO 1000MG EXIR IRAN PARENTERAL 1.0X1000.0 7/1/2008 GMP EXPIRED NONE
DP/1620 GROUP GROUP LIMITED NE PHARMACEUTICAL ORDINARY MG VIAL ON THE 2019-08-
COMPANY FACTORY-2ND KM, DRY VIALS 21 FOR:NBL -
BORUJERD, RU Hard Gelatin
Capsules, Oral
Liquids, Powders
for Oral
Suspension, SVP
256 NDA/MAL/H EXIR UNEED GLOBAL ZIMEXIR 250 AZITHROMY 250MG EXIR IRAN ORAL SOLID 1.0X5.0 7/1/2017 GMP EXPIRED NONE
DP/6068 PHARMACEUTIC GROUP LIMITED CIN PHARMACEUTICAL ORDINARY CAPSULE ON THE 2019-08-
AL COMPANY DIHYDRATE COMPANY-2ND KM CAPSULES BLISTER 21 FOR:NBL -
OF RING ROAD Hard Gelatin
BOROUJERED 69189 Capsules, Oral
IRAN Liquids, Powders
for Oral
Suspension, SVP
257 NDA/MAL/H EXIR UNEED GLOBAL ZIMEXIR AZITHROMY 200MG/5M EXIR IRAN ORAL LIQUID 1.0X30.0 7/1/2017 GMP EXPIRED NONE
DP/6069 PHARMACEUTIC GROUP LIMITED 200MG CIN L PHARMACEUTICAL ORDINARY ML BOTTLE ON THE 2019-08-
AL COMPANY DIHYDRATE COMPANY-2ND KM DRY 21 FOR:NBL -
OF RING ROAD SUSPENSION Hard Gelatin
BOROUJERED 69189 S/SYRUPS/DR Capsules, Oral
IRAN OPS Liquids, Powders
for Oral
Suspension, SVP
258 NDA/MAL/H EXIR UNEED GLOBAL TYLOPHEN® ACETAMINO 120MG/5M EXIR IRAN ORAL LIQUID 1.0X60.0 7/1/2017 GMP EXPIRED NONE
DP/7153 PHARMACEUTIC GROUP LIMITED PHEN L PHARMACEUTICAL ORDINARY ML BOTTLE ON THE 2019-08-
AL COMPANY. COMPANY-2ND KM SUSPENSION 21 FOR:NBL -
OF RING ROAD S Hard Gelatin
BOROUJERED 69189 Capsules, Oral
IRAN Liquids, Powders
for Oral
Suspension, SVP
259 NDA/MAL/H IRAN MEDICAL UNEED GLOBAL LORAXIME CEFOTAXIM 1000MG/M EXIR IRAN PARENTERAL 1.0X1000.0 7/1/2008 GMP EXPIRED NONE
DP/8223 GROUP GROUP LIMITED E L PHARMACEUTICAL ORDINARY MG VIAL ON THE 2019-08-
COMPANY COMPANY-2ND KM DRY VIALS 21 FOR:NBL -
OF RING ROAD Hard Gelatin
BOROUJERED 69189 Capsules, Oral
IRAN Liquids, Powders
for Oral
Suspension, SVP
260 NDA/MAL/H CACHET ASTRA PHARMA CLAVACE AMOXICILLI 457MG/5M ALKEM INDIA ORAL LIQUID 1.0X100.0 7/1/2017 GMP expired on NONE
DP/8248 PHARMACEUTIC (U) LIMITED SUSPENSION N L LABORATORIES LTD-- ORDINARY ML BOTTLE 29-11-2019 FOR
ALS PVT TRIHYDRATE PLOT NO. 167/1, DRY Hard Gelatin
LIMITED +CLAVULAN MAHATMA GANDHI SUSPENSION Capsules (NBL,
ATE UDYONG NAGAR, S/SYRUPS/DR Cephalosporin &
POTASSIUM AMALIYA, DABHEL, OPS Penicillin)
DAMAN,396210 Tablets. (NBL &
INDIA. Cephalosporin)
261 NDA/MAL/H GLENMARK STAR FLEXILOR 8 LORNOXICA 8MG GLENMARK INDIA ORAL SOLID 1.0X3.0X10. 7/1/2014 GMP EXPIRED NONE
DP/0327 PHARMACUTICA PHARMACEUTICA M PHARMACEUTICAL ORDINARY 0 TABLET ON 20/12/2014
LS LTD LS LTD LIMITED;--VILLAGE FILM- BLISTER,1.0 FOR Tablets
KISHANPURA,BADDI- COATED X10.0X10.0 Capsules Oral
NALAGARH ROAD TABLETS TABLET Liquids
TEHSIL BADDI,DISTT. BLISTER Ointments,
SOLAN, HIMACHAL Creams &
PRADESH -174 101 Lotions, Metered
262 NDA/MAL/H GLENMARK STAR IBICAR-50 BECLOMETA 50MCG GLENMARK INDIA LUNG 1.0X200.0 7/1/2013 GMP expired on NONE
DP/0854 PHARMACUTICA PHARMACEUTICA SONE PER PHARMACEUTICALS ADMINISTRA METERED 21-10-2019 for •
LS LTD LS LTD ACTUATIO LTD (UNIT III).-UNIT III TION DOSE Dry powder
N VILLAGE METERED- CANNISTER inhalers(capsules
KISHANPURA,BADDI- DOSE ) • Nasal sprays
NALAGARH ROAD INHALER • Metered Dose
TEHSIL BADDI,DISTT. Inhalers
SOLAN, HIMACHAL
263 NDA/MAL/H GLENMARK STAR IBICAR- 200 BECLOMETA 200MCG GLENMARK INDIA LUNG 1.0X200.0 7/1/2013 GMP expired on NONE
DP/0862 PHARMACUTICA PHARMACEUTICA SONE PER PHARMACEUTICALS ADMINISTRA METERED 21-10-2019 for •
LS LTD LS LTD ACTUATIO LTD (UNIT III).-UNIT III TION DOSE Dry powder
N VILLAGE METERED- CANNISTER inhalers(capsules
KISHANPURA,BADDI- DOSE ) • Nasal sprays
NALAGARH ROAD INHALER • Metered Dose
TEHSIL BADDI,DISTT. Inhalers
SOLAN, HIMACHAL
264 NDA/MAL/H GLENMARK STAR IBICAR-250 BECLOMETA 250MCG GLENMARK INDIA LUNG 1.0X200.0 7/1/2013 GMP expired on NONE
DP/1073 PHARMACUTICA PHARMACEUTICA SONE PER PHARMACEUTICALS ADMINISTRA METERED 21-10-2019 for •
LS LTD LS LTD ACTUATIO LTD (UNIT III).-UNIT III TION DOSE Dry powder
N VILLAGE METERED- CANNISTER inhalers(capsules
KISHANPURA,BADDI- DOSE ) • Nasal sprays
NALAGARH ROAD INHALER • Metered Dose
TEHSIL BADDI,DISTT. Inhalers
SOLAN, HIMACHAL
265 NDA/MAL/H GLENMARK STAR FLEXILOR SR LORNOXICA 16MG GLENMARK INDIA ORAL SOLID 1.0X10.0X1 7/1/2014 GMP EXPIRED NONE
DP/1244 PHARMACUTICA PHARMACEUTICA M PHARMACEUTICAL RETARD FILM- 0.0 TABLET ON 20/12/2014
LS LTD LS LTD LIMITED;--VILLAGE COATED BLISTER FOR Tablets
KISHANPURA,BADDI- TABLETS Capsules Oral
NALAGARH ROAD Liquids
TEHSIL BADDI,DISTT. Ointments,
SOLAN, HIMACHAL Creams &
PRADESH -174 101 Lotions, Metered
266 NDA/MAL/H GLENMARK STAR FLEXILOR P8 LORNOXICA 8MG + GLENMARK INDIA ORAL SOLID 1.0X10.0X1 7/1/2014 GMP EXPIRED NONE
DP/1245 PHARMACUTICA PHARMACEUTICA M+ 500MG PHARMACEUTICAL ORDINARY 0.0 TABLET ON 20/12/2014
LS LTD LS LTD PARACETAM LIMITED;--VILLAGE FILM- BLISTER FOR Tablets
OL KISHANPURA,BADDI- COATED Capsules Oral
NALAGARH ROAD TABLETS Liquids
TEHSIL BADDI,DISTT. Ointments,
SOLAN, HIMACHAL Creams &
PRADESH -174 101 Lotions, Metered
267 NDA/MAL/H GLENMARK STAR GLEMONT CT MONTELUK 4MG GLENMARK INDIA ORAL SOLID 1.0X10.0X1 7/1/2014 GMP EXPIRED NONE
DP/1246 PHARMACEUTIC PHARMACEUTICA 4 AST PHARMACEUTICALS ORDINARY 0.0 TABLET ON 20/12/2014
AL LTD LS LTD LTD-VILLAGE: CHEWABLE BLISTER FOR Tablets
KISHANPURA, BADDI TABLETS Capsules Oral
NALAGARH DISTRICT Liquids
SOLAN - 174101, Ointments,
INDIA Creams &
Lotions, Metered
268 NDA/MAL/H GLENMARK STAR GLEMONT CT MONTELUK 5MG GLENMARK INDIA ORAL SOLID 1.0X10.0X1 7/1/2014 GMP EXPIRED NONE
DP/5079 PHARMACEUTIC PHARMACEUTICA 5 AST PHARMACEUTICALS ORDINARY 0.0 TABLET ON 20/12/2014
AL LTD LS LTD LTD-VILLAGE: CHEWABLE BLISTER FOR Tablets
KISHANPURA, BADDI TABLETS Capsules Oral
NALAGARH DISTRICT Liquids
SOLAN - 174101, Ointments,
INDIA Creams &
Lotions, Metered
269 NDA/MAL/H GLENMARK STAR IBICAR-100 BECLOMETH 100MCG GLENMARK INDIA LUNG 1.0X200.0 7/1/2013 GMP expired on NONE
DP/5397 PHARMACEUTIC PHARMACEUTICA ASONE PER PHARMACEUTICALS ADMINISTRA METERED 21-10-2019 for •
ALS LTD LS LTD ACTUATIO LTD (UNIT III).-UNIT III TION DOSE Dry powder
N VILLAGE METERED- CANNISTER inhalers(capsules
KISHANPURA,BADDI- DOSE ) • Nasal sprays
NALAGARH ROAD INHALER • Metered Dose
TEHSIL BADDI,DISTT. Inhalers
SOLAN, HIMACHAL
270 NDA/MAL/H GLENMARK STAR IBICAR-S SALBUTAM 100MCG/A GLENMARK INDIA LUNG 1.0X200.0 7/1/2013 GMP expired on NONE
DP/5487 PHARMACEUTIC PHARMACEUTICA OL + CTUATION PHARMACEUTICALS ADMINISTRA METERED 21-10-2019 for •
ALS LTD LS LTD BECLOMETA + LTD (UNIT III).-UNIT III TION CFC- DOSE Dry powder
SONE 50MCG/AC VILLAGE FREE CANNISTER inhalers(capsules
TUATION KISHANPURA,BADDI- METERED- ) • Nasal sprays
NALAGARH ROAD DOSE • Metered Dose
TEHSIL BADDI,DISTT. INHALER Inhalers
SOLAN, HIMACHAL
271 NDA/MAL/H GLENMARK STAR COMBIWAVE SALMETERO 25MCG+25 GLENMARK INDIA LUNG 1.0X120.0 7/1/2017 GMP EXPIRED NONE
DP/6039 PHARMACEUTIC PHARMACEUTICA SF 250 L 0MCG/ACT PHARMACEUTICALS ADMINISTRA METERED ON 20/12/2014
AL LTD LS LTD XINAFOATE/ UATION LIMITED-UNIT-I, TION CFC- DOSE FOR Tablets
FLUTICASON VILLAGE KISHANPURA, FREE CANNISTER Capsules Oral
E BADDI, NALAGARH METERED- Liquids
PROPIONAT ROAD, TEHSIL DOSE Ointments,
E NALAGARH,HIMACHA INHALER Creams &
L PRADESH 174 101, Lotions, Metered
272 NDA/MAL/H GLENMARK STAR COMBIWAVE SALMETERO 25MCG+12 GLENMARK INDIA LUNG 1.0X120.0 7/1/2017 GMP EXPIRED NONE
DP/6042 PHARMACEUTIC PHARMACEUTICA SF 125 L 5MCG/ACT PHARMACEUTICALS ADMINISTRA METERED ON 20/12/2014
AL LTD. LS LTD XINAFOATE/ UATION LIMITED-UNIT-I, TION CFC- DOSE FOR Tablets
FLUTICASON VILLAGE KISHANPURA, FREE CANNISTER Capsules Oral
E BADDI, NALAGARH METERED- Liquids
PROPIONAT ROAD, TEHSIL DOSE Ointments,
E NALAGARH,HIMACHA INHALER Creams &
L PRADESH 174 101, Lotions, Metered
273 NDA/MAL/H GLENMARK STAR COMBIWAVE SALMETERO 25MCG+50 GLENMARK INDIA LUNG 1.0X120.0 7/1/2017 GMP EXPIRED NONE
DP/6044 PHARMACEUTIC PHARMACEUTICA SF 50 L MCG/ACTU PHARMACEUTICALS ADMINISTRA METERED ON 20/12/2014
AL LTD. LS LTD XINAFOATE ATION LIMITED-UNIT-I, TION CFC- DOSE FOR Tablets
+ VILLAGE KISHANPURA, FREE CANNISTER Capsules Oral
FLUTICASON BADDI, NALAGARH METERED- Liquids
E ROAD, TEHSIL DOSE Ointments,
PROPIONAT NALAGARH,HIMACHA INHALER Creams &
E L PRADESH 174 101, Lotions, Metered
274 NDA/MAL/H GLENMARK STAR MOMATE AZ MOMETASO 50MCG/14 GLENMARK INDIA NASAL 1.0X150.0 7/1/2017 GMP EXPIRED NONE
DP/6048 PHARMACEUTIC PHARMACEUTICA NE 0MCG PHARMACEUTICALS TOPICAL METERED ON 20/12/2014
AL LTD. LS LTD FUROATE / LTD-VILLAGE: METERED DOSE FOR Tablets
AZELASTINE KISHANPURA, BADDI DOSE BOTTLE Capsules Oral
HYDROCHL NALAGARH DISTRICT AEROSOLS Liquids
ORIDE SOLAN - 174101, Ointments,
INDIA Creams &
Lotions, Metered
275 NDA/MAL/H GLENMARK STAR FLUSORT FLUTICASON 50MCG GLENMARK INDIA NASAL 1.0X120.0 GMP EXPIRED NONE
DP/6318 PHARMACEUTIC PHARMACEUTICA E PER SPRAY
PHARMACEUTICALS TOPICAL METERED ON 20/12/2014
ALS LTD LS LTD PROPIONAT LIMITED.-UNIT SUSPENSION DOSE FOR Tablets
E III,VILLAGE S BOTTLE Capsules Oral
KISHANPURA, BADDI- Liquids
NALAGARH ROAD, Ointments,
TEHSIL NALAGARH, Creams &
DISTT. SOLAN, Lotions, Metered
276 NDA/MAL/H GLENMARK STAR ASCORIL-SF SALBUTAM 2MG+4MG GLENMARK INDIA ORAL LIQUID 1.0X100.0 7/1/2017 GMP EXPIRED NONE
DP/6489 PHARMACEUTIC PHARMACEUTICA OL+BROMH +100MG/1 PHARMACEUTICALS ORDINARY ML BOTTLE ON 20/12/2014
ALS LTD LS LTD EXINE 0ML LTD-VILLAGE, SYRUPS FOR Tablets
HYDROCHL KISHANPURA, BADDI, Capsules Oral
ORIDE+GUAI NALAGARH ROAD, Liquids
FENESIN INDIA Ointments,
Creams &
Lotions, Metered
277 NDA/MAL/H GLENMARK STAR MOMATE MOMETASO 50MCG/ GLENMARK INDIA NASAL 1.0X120.0 7/1/2017 GMP EXPIRED NONE
DP/8232 PHARMACEUTIC PHARMACEUTICA NE SPRAY PHARMACEUTICALS SYSTEMIC METERED ON 20/12/2014
ALS LTD LS LTD FUROATE LTD-VILLAGE: METERED- DOSE FOR Tablets
MONOHYDR KISHANPURA, BADDI DOSE BOTTLE Capsules Oral
ATE NALAGARH DISTRICT LIQUIDS Liquids
SOLAN - 174101, Ointments,
INDIA GLENMARK Creams &
PHARMACEUTICALS Lotions, Metered
278 NDA/MAL/H GLENMARK STAR GLEMONT L MONTELUK 10 MG + 5 GLENMARK INDIA ORAL SOLID 1.0X7.0 11/29/2017 GMP EXPIRED NONE
DP/8322 PHARMACEUTIC PHARMACEUTICA AST MG PHARMACEUTICALS ORDINARY TABLET ON 20/12/2014
ALS LTD LS LTD SODIUM+LE LIMITED-UNIT-I, FILM- BOTTLE FOR Tablets
VOCETIRIZI VILLAGE KISHANPURA, COATED Capsules Oral
NE BADDI, NALAGARH TABLETS Liquids
DIHYDROCH ROAD, TEHSIL Ointments,
LORIDE NALAGARH,HIMACHA Creams &
L PRADESH 174 101, Lotions, Metered
279 NDA/MAL/H I CARE PHARMA VITACARE LTD CHLORAMPH CHLORAMP 5MG/ML GRAND CHINA OPHTHALMI 1.0X1.0X10. 7/1/2013 FACILITY NO NONE
DP/0347 LIMITED ENICOL EYE HENICOL PHARMACEUTICAL(CH C DROPS 0 ML LONGER EXISTS
DROPS INA) CO.LTD-NO.5 BOTTLE
GUTIAN ROAD
QIAOKOU DISTRICT
WUHAN CITY HUBEI
PROVINCE
280 NDA/MAL/H I CARE PHARMA VITACARE LTD ATROPINE ATROPINE IMG/MLGRAND CHINA PARENTERAL 1.0X5.0X10. 7/1/2013 FAILED GMP ON NONE
DP/0361 LIMITED INJECTION PHARMACEUTICAL ORDINARY I 0 ML 14th,15th and
(CHINA) CO LIMITED- V AMPOULES AMPOULE 16th August
NO.11,LAKE ROAD , 2019 FOR NBL •
JINYINHU Tablets (Coated
ECOLOGICAL PARK, and Uncoated) •
DONGXIHU DISTRICT Hard Gelatin
,WUHAN, HUBEI Capsules • SVP
281 NDA/MAL/H I CARE PHARMA VITACARE LTD AMINOPHYL AMINOPHYL 250MG/10 WUHAN GRAND CHINA PARENTERAL 1.0X10.0X1 7/1/2013 FAILED GMP ON NONE
DP/0379 LIMITED LINE LINE ML PHARMACEUTICALS ORDINARY I 0.0 ML 14th,15th and
INJECTION GROUP CO.LTD-M/S V VIALS VIAL,1.0X1. 16th August
NO. 5 GUTIAN RD, 0X5.0X10.0 2019 FOR NBL •
WUHAN, HUBEI X10.0 ML Tablets (Coated
CHINA GRAND AMPOULE and Uncoated) •
PHARMACEUTICAL Hard Gelatin
(CHINA) CO LIMITED- Capsules • SVP
282 NDA/MAL/H I CARE PHARMA VITACARE LTD CALCIUM CALCIUM 1G/10ML GRAND CHINA PARENTERAL 1.0X10.0X1 7/1/2013 FAILED GMP ON NONE
DP/0452 LIMITED GLUCONATE GLUCONATE PHARMACEUTICAL ORDINARY 0.0 ML 14th,15th and
INJECTION INJECTION (CHINA) CO LIMITED- INFUSION AMPOULE,1 16th August
NO.11,LAKE ROAD , AMPOULES .0X1.0X5.0X 2019 FOR NBL •
JINYINHU 10.0X10.0 Tablets (Coated
ECOLOGICAL PARK, ML and Uncoated) •
DONGXIHU DISTRICT AMPOULE Hard Gelatin
,WUHAN, HUBEI Capsules • SVP
283 NDA/MAL/H I CARE PHARMA VITACARE LTD ADRENALINE ADRENALIN 1MG/1ML WUHAN GRAND CHINA PARENTERAL 1.0X1.0X10. 7/1/2013 FACILITY NO NONE
DP/0455 LIMITED INJECTION E PHARMACEUTICALS ORDINARY I 0X1.0 ML LONGER EXISTS
INJECTION GROUP CO.LTD-M/S V AMPOULES AMPOULE
NO. 5 GUTIAN RD,
WUHAN, HUBEI
CHINA

284 NDA/MAL/H I CARE PHARMA VITACARE LTD INDOX INDOMETH 25MG WUHAN GRAND CHINA ORAL SOLID 1.0X1000.0 7/1/2013 FACILITY NO NONE
DP/0955 LIMITED ACIN USP PHARMACEUTICAL ORDINARY CAPSULE LONGER EXISTS
GROUP.CO.LTD-NO.5 CAPSULES CONTAINER
GUTIAN ROAD ,1.0X10.0X1
WUHAN HUBEL PR OF 0.0
CHINA CAPSULE
BLISTER
285 NDA/MAL/H I CARE PHARMA VITACARE LTD GENTAMICIN GENTAMICI 80MG/2ML GRAND CHINA PARENTERAL 1.0X10.0X2. 7/1/2013 FAILED GMP ON NONE
DP/0956 LIMITED INJECTION N PHARMACEUTICAL(CH ORDINARY 0 ML 14th,15th and
BP INA) CO.LTD-NO.5 AMPOULES AMPOULE,1 16th August
GUTIAN ROAD .0X5.0X1.0X 2019 FOR NBL •
QIAOKOU DISTRICT 10.0X2.0 Tablets (Coated
WUHAN CITY HUBEI ML and Uncoated) •
PROVINCE GRAND AMPOULE Hard Gelatin
PHARMACEUTICAL Capsules • SVP
286 NDA/MAL/H I CARE PHARMA VITACARE LTD FUROSEMIDE FUROSEMID 10MG/2ML GRAND CHINA PARENTERAL 1.0X10.0X2. 7/1/2013 FAILED GMP ON NONE
DP/0958 LIMITED E PHARMACEUTICAL(CH ORDINARY 0 ML 14th,15th and
INA) CO.LTD-NO.5 AMPOULES AMPOULE 16th August
GUTIAN ROAD 2019 FOR NBL •
QIAOKOU DISTRICT Tablets (Coated
WUHAN CITY HUBEI and Uncoated) •
PROVINCE GRAND Hard Gelatin
PHARMACEUTICAL Capsules • SVP
287 NDA/MAL/H GULF OMASI MED TRIMOL DS SULFAMETH 800MG+16 GULF UNITED ORAL SOLID 1.0X1.0X10. 7/1/2013 GMP EXPIRED NONE
DP/0473 PHARMACEUTIC LIMITED OXAZOLE + 0MG PHERMACUTICALS ARAB ORDINARY 0 TABLET ON 30-08-19
ALS INDUSTRIES TRIMETHOP INDUSTRIES -AIR PORT EMIRATES TABLETS BLISTER FOR NBL; SVP
RIM ROAD DIGDAGA RAKA sol. & lyo.
powders for inj.,
Tabs, HGC, oral
susp powders,
Oral liquids
288 NDA/MAL/H JULPHAR GULF GAMA VANCOLON VANCOMYCI 0.5G/VIAL JULPHAR GULF UNITED PARENTERAL 1.0X1.0 7/1/2012 GMP EXPIRED NONE
DP/0949 PHARMACEUTIC PHARMACEUTICA N PHARMACEUTICAL ARAB ORDINARY I VIAL ON 30-08-19
AL INDUSTRIES LS (U) LIMITED INDUSTRIES-DIGDIGA EMIRATES V VIALS CARTON FOR NBL; SVP
AREA, AIR PORT ROAD sol. & lyo.
P.O BOX 977 RAS-AL powders for inj.,
KHAIMAH UAE Tabs, HGC, oral
susp powders,
Oral liquids
289 NDA/MAL/H JULPHAR GULF OMASI MED EPOTIN ERYTHROPO 4000I.U JULPHAR GULF UNITED PARENTERAL 1.0X10.0 7/1/2012 GMP EXPIRED NONE
DP/0950 PHARMACEUTIC LIMITED IETIN PHARMACEUTICAL ARAB ORDINARY PREFILLED ON 30-08-19
AL INDUSTRIES INDUSTRIES-DIGDIGA EMIRATES PRE-FILLED SYRINGE FOR NBL; SVP
AREA, AIR PORT ROAD SYRINGES CARTON sol. & lyo.
P.O BOX 977 RAS-AL powders for inj.,
KHAIMAH UAE Tabs, HGC, oral
susp powders,
Oral liquids
290 NDA/MAL/H GULF OMASI MED MEBO B- 0.25%W/W GULF UNITED TOPICAL 1.0X15.0 G 7/1/1999 GMP EXPIRED NONE
DP/1272 PHARMACEUTIC LIMITED HERBAL SITOSTEROL PHARMACEUTICAL ARAB EXTERNAL TUBE,1.0X3 ON 30-08-19
AL OINTMENT INDUSTRIES EMIRATES OINTMENTS 0.0 G TUBE FOR NBL; SVP
INDUSTRIES(JUL (JULPHAR)-AIRPORT sol. & lyo.
PHAR) ROAD, powders for inj.,
DIGDAGA, P.O.BOX: Tabs, HGC, oral
997, susp powders,
RAS AL KHAIMAH, Oral liquids
291 NDA/MAL/H JULPHAR GULF OMASI MED RECOCEF CEFACLOR 125MG/5M GULF UNITED ORAL LIQUID 1.0X75.0 7/1/2008 GMP EXPIRED NONE
DP/3539 PHARMACEUTIC LIMITED L PHARMACEUTICALS ARAB ORDINARY ML BOTTLE ON 30-08-19
AL INDUSTRIES INDUSTRIES - EMIRATES LIQUIDS FOR NBL; SVP
UNKNOWM sol. & lyo.
powders for inj.,
Tabs, HGC, oral
susp powders,
Oral liquids
292 NDA/MAL/H JULPHAR GULF OMASI MED ACECLOFAR ACECLOFEN 100MG GULF UNITED ORAL SOLID 1.0X10.0 7/1/2013 GMP EXPIRED NONE
DP/4036 PHARMACEUTIC LIMITED AC PHARMACEUTICAL ARAB ORDINARY TABLET ON 30-08-19
AL INDUSTRIES INDUSTRIES EMIRATES TABLETS BLISTER FOR NBL; SVP
(JULPHAR)-AIRPORT sol. & lyo.
ROAD, powders for inj.,
DIGDAGA, P.O.BOX: Tabs, HGC, oral
997, susp powders,
RAS AL KHAIMAH, Oral liquids
293 NDA/MAL/H JULPHAR GULF OMASI MED FULICRON FERROUS 150MG+50 GULF UNITED ORAL SOLID 1.0X3.0X10. 7/1/2013 GMP EXPIRED NONE
DP/4977 PHARMACEUTIC LIMITED SULPHATE+F 0MCG PHARMACEUTICAL ARAB ORDINARY 0 TABLET ON 30-08-19
AL INDUSTRIES OLIC ACID INDUSTRIES EMIRATES TABLETS BLISTER FOR NBL; SVP
(JULPHAR)-AIRPORT sol. & lyo.
ROAD, powders for inj.,
DIGDAGA, P.O.BOX: Tabs, HGC, oral
997, susp powders,
RAS AL KHAIMAH, Oral liquids
294 NDA/MAL/H GULF OMASI MED FEROMAX IRON 20MG/ML GULF UNITED PARENTERAL 1.0X5.0X5.0 7/1/2014 GMP EXPIRED NONE
DP/5639 PHARMACEUTIC LIMITED SUCROSE PHARMACEUTICAL ARAB ORDINARY ML ON 30-08-19
AL INDUSTRIES EMIRATES INFUSION AMPOULE FOR NBL; SVP
INDUSTRIES(JUL (JULPHAR)-AIRPORT AMPOULES sol. & lyo.
PHAR). ROAD, powders for inj.,
DIGDAGA, P.O.BOX: Tabs, HGC, oral
997, susp powders,
RAS AL KHAIMAH, Oral liquids
295 NDA/MAL/H GULF GOODMAN CLOFEN DICLOFENA 12.5MG GULF UNITED RECTAL 1.0X2.0X5.0 9/26/2018 GMP EXPIRED NONE
DP/6467 PHARMACEUTIC INTERNATIONAL C SODIUM PHARMACEUTICALS ARAB SYSTEMIC SUPPOSITO ON 30-08-19
AL LTD INDUSTRIES"JULPHAR EMIRATES SUPPOSITORI RY STRIP FOR NBL; SVP
INDUSTRIES(JUL "-P.O.BOX 997 ES sol. & lyo.
PHAR). AIRPORT powders for inj.,
ROAD,DIGDAGA Tabs, HGC, oral
STREET RAS AL susp powders,
KHAIMAH,U.A.E Oral liquids
296 NDA/MAL/H GULF OMASI MED JUSPRIN 81 ASPIRIN 81MG GULF UNITED ORAL SOLID 1.0X2.0X20. 7/1/2017 GMP EXPIRED NONE
DP/6469 PHARMACEUTIC LIMITED E/C TABLETS PHARMACEUTICAL ARAB ORDINARY 0 TABLET ON 30-08-19
AL INDUSTRIES EMIRATES ENTERIC- BLISTER FOR NBL; SVP
INDUSTRIES(JUL (JULPHAR)-AIRPORT COATED sol. & lyo.
PHAR). ROAD, TABLETS powders for inj.,
DIGDAGA STREET Tabs, HGC, oral
RAS AL KHAIMAH susp powders,
Oral liquids
297 NDA/MAL/H GULF GAMA CEFUZIME CEFUROXIM 500MG GULF UNITED ORAL SOLID 1.0X10.0 1/31/2018 GMP EXPIRED NONE
DP/6471 PHARMACEUTIC PHARMACEUTICA 500 E AXETIL PHARMACEUTICALS ARAB ORDINARY TABLET ON 30-08-19
AL LS (U) LIMITED INDUSTRIES"JULPHAR EMIRATES FILM- BLISTER FOR NBL; SVP
INDUSTRIES(JUL "-P.O.BOX 997 COATED sol. & lyo.
PHAR). AIRPORT TABLETS powders for inj.,
ROAD,DIGDAGA Tabs, HGC, oral
STREET RAS AL susp powders,
KHAIMAH,U.A.E Oral liquids
298 NDA/MAL/H GULF GAMA MOXAL ALUMINIUM 405 GULF UNITED ORAL LIQUID 1.0X200.0 7/1/2017 GMP EXPIRED NONE
DP/6475 PHARMACEUTIC PHARMACEUTICA SUSPENSION HYDROXIDE MG+100 PHARMACEUTICAL ARAB ORDINARY ML BOTTLE ON 30-08-19
AL LS (U) LIMITED +MAGNESIU MG/ 5ML INDUSTRIES EMIRATES SUSPENSION FOR NBL; SVP
INDUSTRIES(JUL M (JULPHAR)-AIRPORT S sol. & lyo.
PHAR). HYDROXIDE ROAD, powders for inj.,
DIGDAGA STREET Tabs, HGC, oral
RAS AL KHAIMAH susp powders,
Oral liquids
299 NDA/MAL/H GULF OMASI MED RANTAG RANITIDINE 50MG/2ML GULF UNITED PARENTERAL 1.0X1.0X5.0 7/25/2018 GMP EXPIRED NONE
DP/6478 PHARMACEUTIC LIMITED INJECTION HYDROCHL PHARMACEUTICAL ARAB ORDINARY X2.0 ML ON 30-08-19
AL ORIDE INDUSTRIES EMIRATES AMPOULES AMPOULE FOR NBL; SVP
INDUSTRIES(JUL (JULPHAR)-AIRPORT sol. & lyo.
PHAR). ROAD, powders for inj.,
DIGDAGA STREET Tabs, HGC, oral
RAS AL KHAIMAH susp powders,
Oral liquids
300 NDA/MAL/H GULF OMASI MED MOXAL PLUS DRIED 200MG+20 GULF UNITED ORAL SOLID 1.0X3.0X10. 7/1/2017 GMP EXPIRED NONE
DP/6481 PHARMACEUTIC LIMITED CHEWABLE ALUMINIUM 0MG+25M PHARMACEUTICAL ARAB ORDINARY 0 TABLET ON 30-08-19
AL TABLETS HYDROXIDE G INDUSTRIES EMIRATES CHEWABLE BLISTER FOR NBL; SVP
INDUSTRIES(JUL GEL+MAGN (JULPHAR)-AIRPORT TABLETS sol. & lyo.
PHAR). ESIUM ROAD, powders for inj.,
HYDROXIDE DIGDAGA STREET Tabs, HGC, oral
+SIMETHICO RAS AL KHAIMAH susp powders,
NE Oral liquids
301 NDA/MAL/H GULF GAMA MOXAL II ALUMINIUM 215MG+80 GULF UNITED ORAL LIQUID 1.0X100.0 7/1/2017 GMP EXPIRED NONE
DP/6483 PHARMACEUTIC PHARMACEUTICA SUSPENSION HYDROXIDE MG/5ML PHARMACEUTICAL ARAB ORDINARY ML BOTTLE ON 30-08-19
AL LS (U) LIMITED + INDUSTRIES EMIRATES SUSPENSION FOR NBL; SVP
INDUSTRIES(JUL MAGNESIU (JULPHAR)-AIRPORT S sol. & lyo.
PHAR). M ROAD, powders for inj.,
HYDROXIDE DIGDAGA STREET Tabs, HGC, oral
RAS AL KHAIMAH susp powders,
Oral liquids
302 NDA/MAL/H GULF OMASI MED CEFUZIME CEFUROXIM 750MG GULF UNITED PARENTERAL 1.0X750.0 1/31/2018 GMP EXPIRED NONE
DP/6485 PHARMACEUTIC LIMITED 750 E SODIUM PHARMACEUTICAL ARAB ORDINARY MG VIAL ON 30-08-19
AL INDUSTRIES EMIRATES DRY VIALS FOR NBL; SVP
INDUSTRIES(JUL (JULPHAR)-AIRPORT sol. & lyo.
PHAR). ROAD, powders for inj.,
DIGDAGA, P.O.BOX: Tabs, HGC, oral
997, susp powders,
RAS AL KHAIMAH, Oral liquids
303 NDA/MAL/H GULF GAMA VANCOLON VANCOMYCI 1G GULF UNITED PARENTERAL 1.0X1.0 G 3/28/2018 GMP EXPIRED NONE
DP/6540 PHARMACEUTIC PHARMACEUTICA N PHARMACEUTICALS ARAB ORDINARY VIAL ON 30-08-19
AL LS (U) LIMITED HYDROCHL INDUSTRIES"JULPHAR EMIRATES DRY VIALS FOR NBL; SVP
INDUSTRIES(JUL ORIDE "-P.O.BOX 997 sol. & lyo.
PHAR). AIRPORT powders for inj.,
ROAD,DIGDAGA Tabs, HGC, oral
STREET RAS AL susp powders,
KHAIMAH,U.A.E Oral liquids
304 NDA/MAL/H GULF GAMA DIALON METFORMI 1000MG GULF UNITED ORAL SOLID 1.0X3.0X10. 1/31/2018 GMP EXPIRED NONE
DP/6541 PHARMACEUTIC PHARMACEUTICA 1000 MG N PHARMACEUTICALS ARAB ORDINARY 0 TABLET ON 30-08-19
AL LS (U) LIMITED HYDROCHL INDUSTRIES"JULPHAR EMIRATES FILM- BLISTER FOR NBL; SVP
INDUSTRIES(JUL ORIDE "-P.O.BOX 997 COATED sol. & lyo.
PHAR). AIRPORT TABLETS powders for inj.,
ROAD,DIGDAGA Tabs, HGC, oral
STREET RAS AL susp powders,
KHAIMAH,U.A.E Oral liquids
305 NDA/MAL/H GULF OMASI MED ORAMAX FLUCONAZO 150MG GULF UNITED ORAL SOLID 1.0X1.0X1.0 3/28/2018 GMP EXPIRED NONE
DP/6544 PHARMACEUTIC LIMITED 150MG LE PHARMACEUTICALS ARAB ORDINARY CAPSULE ON 30-08-19
AL INDUSTRIES"JULPHAR EMIRATES CAPSULES BLISTER FOR NBL; SVP
INDUSTRIES(JUL "-P.O.BOX 997 sol. & lyo.
PHAR). AIRPORT powders for inj.,
ROAD,DIGDAGA Tabs, HGC, oral
STREET RAS AL susp powders,
KHAIMAH,U.A.E Oral liquids
306 NDA/MAL/H GULF OMASI MED AMYDRAMIN DIPHENHYD 7MG+28.5 GULF UNITED ORAL LIQUID 1.0X120.0 7/1/2017 GMP EXPIRED NONE
DP/6547 PHARMACEUTIC LIMITED E RAMINE MG+0.55 PHARMACEUTICAL ARAB ORDINARY ML BOTTLE ON 30-08-19
AL PAEDIATRIC HYDROCHL MG/5 ML INDUSTRIES EMIRATES SYRUPS FOR NBL; SVP
INDUSTRIES(JUL SYRUP ORIDE+SODI (JULPHAR)-AIRPORT sol. & lyo.
PHAR). UM ROAD, powders for inj.,
CITRATE+M DIGDAGA STREET Tabs, HGC, oral
ENTHOL RAS AL KHAIMAH susp powders,
Oral liquids
307 NDA/MAL/H GULF GOODMAN CEFUZIME CEFUROXIM 250MG GULF UNITED ORAL SOLID 1.0X2.0X5.0 9/26/2018 GMP EXPIRED NONE
DP/6560 PHARMACEUTIC INTERNATIONAL 250MG E AXETIL PHARMACEUTICALS ARAB ORDINARY TABLET ON 30-08-19
AL LTD INDUSTRIES"JULPHAR EMIRATES FILM- BLISTER FOR NBL; SVP
INDUSTRIES(JUL "-P.O.BOX 997 COATED sol. & lyo.
PHAR). AIRPORT TABLETS powders for inj.,
ROAD,DIGDAGA Tabs, HGC, oral
STREET RAS AL susp powders,
KHAIMAH,U.A.E Oral liquids
308 NDA/MAL/H GULF OMASI MED RISEK OMEPRAZO 20MG GULF UNITED ORAL SOLID 1.0X14.0 1/31/2018 GMP EXPIRED NONE
DP/6561 PHARMACEUTIC LIMITED LE PHARMACEUTICAL ARAB ORDINARY CAPSULE ON 30-08-19
AL INDUSTRIES EMIRATES CAPSULES BOTTLE FOR NBL; SVP
INDUSTRIES(JUL (JULPHAR)-AIRPORT sol. & lyo.
PHAR). ROAD, powders for inj.,
DIGDAGA STREET Tabs, HGC, oral
RAS AL KHAIMAH susp powders,
Oral liquids
309 NDA/MAL/H GULF GAMA ADOL EXTRA PARACETAM 500MG+65 GULF UNITED ORAL SOLID 1.0X2.0X12. 7/1/2017 GMP EXPIRED NONE
DP/7030 PHARMACEUTIC PHARMACEUTICA OL+CAFFEIN MG PHARMACEUTICAL ARAB ORDINARY 0 TABLET ON 30-08-19
AL LS (U) LIMITED E INDUSTRIES EMIRATES TABLETS BLISTER FOR NBL; SVP
INDUSTRIES(JUL (JULPHAR)-AIRPORT sol. & lyo.
PHAR). ROAD, powders for inj.,
DIGDAGA STREET Tabs, HGC, oral
RAS AL KHAIMAH susp powders,
Oral liquids
310 NDA/MAL/H GULF GAMA GLYPRIDE GLIMEPIRID 3MG GULF UNITED ORAL SOLID 1.0X3.0X10. 1/31/2018 GMP EXPIRED NONE
DP/7035 PHARMACEUTIC PHARMACEUTICA 3MG E PHARMACEUTICALS ARAB ORDINARY 0 TABLET ON 30-08-19
AL LS (U) LIMITED INDUSTRIES"JULPHAR EMIRATES TABLETS BLISTER FOR NBL; SVP
INDUSTRIES(JUL "-P.O.BOX 997 sol. & lyo.
PHAR). AIRPORT powders for inj.,
ROAD,DIGDAGA Tabs, HGC, oral
STREET RAS AL susp powders,
KHAIMAH,U.A.E Oral liquids
311 NDA/MAL/H GULF OMASI MED XEMADERM MOMETASO 0.1%W/W GULF UNITED TOPICAL 1.0X30.0 G 7/1/2017 GMP EXPIRED NONE
DP/7046 PHARMACEUTIC LIMITED 0.1% CREAM NE PHARMACEUTICAL ARAB EXTERNAL TUBE ON 30-08-19
AL FUROATE INDUSTRIES EMIRATES CREAMS FOR NBL; SVP
INDUSTRIES(JUL (JULPHAR)-AIRPORT sol. & lyo.
PHAR). ROAD, powders for inj.,
DIGDAGA STREET Tabs, HGC, oral
RAS AL KHAIMAH susp powders,
Oral liquids
312 NDA/MAL/H GULF OMASI MED XEMADERM0 MOMETASO 0.1%W/W GULF UNITED TOPICAL 1.0X30.0 G 7/1/2017 GMP EXPIRED NONE
DP/7047 PHARMACEUTIC LIMITED .1% NE PHARMACEUTICAL ARAB EXTERNAL TUBE ON 30-08-19
AL OINTMENT FUROATE INDUSTRIES EMIRATES OINTMENTS FOR NBL; SVP
INDUSTRIES(JUL (JULPHAR)-AIRPORT sol. & lyo.
PHAR). ROAD, powders for inj.,
DIGDAGA STREET Tabs, HGC, oral
RAS AL KHAIMAH susp powders,
Oral liquids
313 NDA/MAL/H GULF OMASI MED PANDERM NYSTATIN+ 10,000,000 GULF UNITED TOPICAL 1.0X15.0 G 7/1/2017 GMP EXPIRED NONE
DP/7050 PHARMACEUTIC LIMITED SKIN NEOMYCIN I.U+2.5MG PHARMACEUTICAL ARAB EXTERNAL TUBE ON 30-08-19
AL OINTMENT SULFATE+G +0.25MG+1 INDUSTRIES EMIRATES OINTMENTS FOR NBL; SVP
INDUSTRIES(JUL RAMICIDIN+ MG (JULPHAR)-AIRPORT sol. & lyo.
PHAR). TRIAMCINO ROAD, powders for inj.,
LONE DIGDAGA STREET Tabs, HGC, oral
RAS AL KHAIMAH susp powders,
Oral liquids
314 NDA/MAL/H GULF OMASI MED DEXIPAN DEXPANTHE 0.05%W/W GULF UNITED TOPICAL 1.0X20.0 G 7/1/2017 GMP EXPIRED NONE
DP/7051 PHARMACEUTIC LIMITED CREAM NOL PHARMACEUTICAL ARAB EXTERNAL TUBE ON 30-08-19
AL INDUSTRIES EMIRATES CREAMS FOR NBL; SVP
INDUSTRIES(JUL (JULPHAR)-AIRPORT sol. & lyo.
PHAR). ROAD, powders for inj.,
DIGDAGA STREET Tabs, HGC, oral
RAS AL KHAIMAH susp powders,
Oral liquids
315 NDA/MAL/H GULF OMASI MED BCOOL CETYLPYRIDI 1MG +1MG GULF UNITED ORAL SOLID 1.0X2.0X9.0 7/1/2017 GMP EXPIRED NONE
DP/8237 PHARMACEUTIC LIMITED NIUM PHARMACEUTICAL ARAB ORDINARY LOZENGE ON 30-08-19
AL CHLORIDE + INDUSTRIES EMIRATES LOZENGES BLISTER FOR NBL; SVP
INDUSTRIES(JUL LIDOCAINE (JULPHAR)-AIRPORT sol. & lyo.
PHAR). HYDROCHL ROAD, powders for inj.,
ORIDE DIGDAGA STREET Tabs, HGC, oral
RAS AL KHAIMAH susp powders,
Oral liquids
316 NDA/MAL/H GULF OMASI MED TRIAXONE CEFTRIAXO 0.5G GULF UNITED PARENTERAL 1.0X1.0 1/31/2018 GMP EXPIRED NONE
DP/8498 PHARMACEUTIC LIMITED 0.5G NE PHARMACEUTICALS ARAB ORDINARY VIAL ON 30-08-19
AL INDUSTRIES"JULPHAR EMIRATES DRY VIALS CARTON + FOR NBL; SVP
INDUSTRIES(JUL "-P.O.BOX 997 5 ML sol. & lyo.
PHAR) AIRPORT AMPOULE powders for inj.,
ROAD,DIGDAGA OF WATER Tabs, HGC, oral
STREET RAS AL FOR susp powders,
KHAIMAH,U.A.E INJECTION Oral liquids
317 NDA/MAL/H GULF OMASI MED JULMENTIN AMOXICILLI 600 MG / 5 GULF INDIA ORAL LIQUID 1.0X1.0X10 7/25/2018 GMP EXPIRED NONE
DP/8948 PHARMACEUTIC LIMITED ES N ML + 42.9 PHARMACEUTICAL ORDINARY 0.0 ML ON 30-08-19
AL TRIHYDRATE MG / 5 ML INDUSTRIES DRY BOTTLE FOR NBL; SVP
INDUSTRIES(JUL + (JULPHAR) -- SUSPENSION sol. & lyo.
PHAR). CLAVULANA DIGDAGA, AIRPORT S/SYRUPS/DR powders for inj.,
TE STREET OPS Tabs, HGC, oral
POTASSIUM RAS AL KHAIMAH susp powders,
UNITED ARAB Oral liquids
318 NDA/MAL/H ICPA HEALTH METRO HEXIDINE® CHLORHEXI 0.2 %W/V ICPA HEALTH INDIA TOPICAL 1.0X160.0 11/29/2017 GMP EXPIRED NONE
DP/7078 PRODUCTS LTD PHARMACEUTICA DINE PRODUCTS LIMITED- EXTERNAL ML BOTTLE ON 14/11/2019
LS LIMITED GLUCONATE 286/287, GIDC, LIQUIDS FOR Non Beta
ANKLESHWAR- Lactam lines; •
393002. Gels and
GUJARAT, INDIA. ointments. •
External
solutions.
319 NDA/MAL/H BEIJING HOLLEY SUPER PROCILIN FORTIFIED 4MU SHANDONG XIER CHINA PARENTERAL 1.0X10.0 7/1/2013 FAILED GMP ON Reyoung
DP/6682 COTEC PHARMA PHARMACEUTICA PROCAINE KANGTAI ORDINARY VIAL 2018-08-31 FOR Pharmaceutical
CHINA LS LIMITED BENZYLPENI PHARMACEUTICALS DRY VIALS CARTON,1.0 Non-Beta Co. Ltd-No. 6
CILLIN CO. LTD-PRIVATE X50.0 VIAL Lactam dosage Erlangshan
ECONOMY CARTON forms: • Small Road, Yiyuan,
GARDEN,XINYAN Volume Shandong
JINING Parenterals 256100
CITY,SHANDONG,CHI –Solutions in
320 NDA/MAL/H ABACUS ABACUS PHARMA CINAMET- CIMETIDINE 400MG JIANGSU PENGYAO CHINA ORAL SOLID 1.0X10.0X1 7/1/2015 FAILED GMP ON NONE
DP/0302 PHARMA LTD (AFRICA) LIMITED 400 PHARMACEUTICALS ORDINARY 0.0 TABLET 2018-08-28 FOR
CO. LTD -NO. 10 TABLETS BLISTER Non Beta
CHAQUAN ROAD Lactam: • SVP-
YIXING CITY JIANGSU Solutions in
PROVINCE Ampoules •
Tablets • Hard
Gelatin Capsules
321 NDA/MAL/H ABACUS ABACUS PHARMA FALCIMAX- QUININE 600MG/2M JIANGSU PENGYAO CHINA PARENTERAL 1.0X10.0X1 7/1/2014 FAILED GMP ON NONE
DP/0561 PHARMA (A) (AFRICA) LIMITED 600 DIHYDROCH L PHARMACEUTICALS ORDINARY 0.0X2.0 ML 2018-08-28 FOR
LTD. LORIDE CO. LTD-NO. 10 AMPOULES AMPOULE Non Beta
CHAQUAN Lactam: • SVP-
ROAD,YIXING CITY, Solutions in
CHINA Ampoules •
Tablets • Hard
Gelatin Capsules
322 NDA/MAL/H ROYAL GROUP HARLEYS QUININE QUININE 600MG/2M JIANGSU PENGYAO CHINA PARENTERAL 1.0X10.0X2. FAILED GMP ON NONE
DP/0998 UGANDA DIHYDROCHL DIHYDROCH L PHARMACEUTICALS ORDINARY 0 ML 2018-08-28 FOR
LIMITED ORIDE LORIDE CO. LTD-NO. 10 AMPOULES AMPOULE,1 Non Beta
INJECTION CHAQUAN .0X1.0X5.0X Lactam: • SVP-
ROAD,YIXING CITY, 10.0X2.0 Solutions in
CHINA GRAND ML Ampoules •
PHARMACEUTICAL AMPOULE Tablets • Hard
(CHINA) CO LIMITED- Gelatin Capsules
323 NDA/MAL/H ROYAL PHARMA ROYAL PHARMA AMINOPHYL AMINOPHYL 25 MG / SHANDONG XIER CHINA PARENTERAL 1.0X10.0X1 7/1/2016 FAILED GMP ON NONE
DP/8412 2011 LIMITED 2011 LIMITED LINE LINE ML KANGTAI ORDINARY 0.0 ML 2018-08-31 FOR
PHARMACEUTICAL AMPOULES AMPOULE,1 Non-Beta
CO. LTD-PRIVATE .0X50.0X10. Lactam dosage
ECONOMY 0 ML forms: • Small
ZONE,YANZHOU AMPOULE Volume
DISTRICT,SHANDONG, Parenterals
CHINA PR –Solutions in
324 NDA/MAL/H ABACUS ABACUS PHARMA CINAMET- CIMETIDINE 200MG JIANGSU PENGYAO CHINA ORAL SOLID 1.0X10.0X1 7/1/2013 FAILED GMP ON NONE
DP/1819 PHARMA (A) (AFRICA) LIMITED 200 PHARMACEUTICALS ORDINARY 0.0 TABLET 2018-08-28 FOR
LTD. CO. LTD -NO. 10 TABLETS BLISTER Non Beta
CHAQUAN ROAD Lactam: • SVP-
YIXING CITY JIANGSU Solutions in
PROVINCE Ampoules •
Tablets • Hard
Gelatin Capsules
325 NDA/MAL/H ROYAL PHARMA ROYAL PHARMA CHLORAMPH CHLORAMP 250MG SHANDONG XIER CHINA ORAL SOLID 1.0X1000.0 7/1/2001 FAILED GMP ON NONE
DP/8413 2011 LIMITED 2011 LIMITED ENICOL HENICOL KANGTAI ORDINARY CAPSULE 2018-08-31 FOR
CAPSULE BP PHARMACEUTICALS CAPSULES CONTAINER Non-Beta
CO. LTD PRIVATE- ,1.0X500.0 Lactam dosage
PRIVATE ECONOMY CAPSULE forms: • Small
ZONE,XINYAN TOWN, CONTAINER Volume
YANZHOU DISTRICT, ,1.0X10.0X1 Parenterals
JINING 0.0 –Solutions in
326 NDA/MAL/H ROYAL PHARMA ROYAL PHARMA TETRACYCLI TETRACYCLI 250MG SHANDONG XIER CHINA ORAL SOLID 1.0X1000.0 7/1/2011 FAILED GMP ON NONE
DP/8417 2011 LIMITED 2011 LIMITED NE CAPSULE NE KANGTAI ORDINARY CAPSULE 2018-08-31 FOR
BP HYDROCHL PHARMACEUTICALS CAPSULES CONTAINER Non-Beta
ORIDE CO. LTD PRIVATE- ,1.0X500.0 Lactam dosage
PRIVATE ECONOMY CAPSULE forms: • Small
ZONE,XINYAN TOWN, CONTAINER Volume
YANZHOU DISTRICT, Parenterals
JINING –Solutions in
327 NDA/MAL/H ABACUS ABACUS PHARMA DI - QUIN 40MG + JIANGSU PENGYAO CHINA ORAL SOLID 1.0X9.0 FAILED GMP ON NONE
DP/7687 PHARMA (AFRICA) LIMITED DIHYDROAR 320MG PHARMACEUTICALS ORDINARY TABLET 2018-08-28 FOR
(AFRICA) TEMISININ+ CO. LTD-NO. 10 TABLETS BLISTER Non Beta
LIMITED PIPERAQUIN CHAQUAN Lactam: • SVP-
E ROAD,YIXING CITY, Solutions in
PHOSPHATE CHINA Ampoules •
Tablets • Hard
Gelatin Capsules
328 NDA/MAL/H I CARE PHARMA VITACARE LTD VITAMIN B VITAMIN 20MG+2M GRAND CHINA PARENTERAL 1.0X10.0X2. 7/1/2013 FAILED GMP ON NONE
DP/0960 LIMITED COMPLEX B1+VITAMI G+27.4MG PHARMACEUTICAL ORDINARY 0 ML 14th,15th and
INJECTION N B6+ +1MG+30 (CHINA) CO LIMITED- AMPOULES AMPOULE,1 16th August
VITAMIN MG NO.11,LAKE ROAD , .0X1.0X5.0X 2019 FOR NBL •
B2+VITAMI JINYINHU 10.0X2.0 Tablets (Coated
N B5+ ECOLOGICAL PARK, ML and Uncoated) •
NICOTINAM DONGXIHU DISTRICT AMPOULE Hard Gelatin
IDE ,WUHAN, HUBEI Capsules • SVP
329 NDA/MAL/H ROYAL GROUP HARLEYS CHLORAMPH CHLORAMP 250MG JIANGSU PENGYAO CHINA ORAL SOLID 1.0X1000.0 7/1/2011 FAILED GMP ON NONE
DP/8098 UGANDA ENICOL HENICOL PHARMACEUTICAL CO ORDINARY CAPSULE 2018-08-28 FOR
LIMITED CAPSULES BP LTD .-NO. 10 CAPSULES CONTAINER Non Beta
CHAQUAN ROAD ,1.0X10.0X1 Lactam: • SVP-
YICHENG TOWN 0.0 Solutions in
YIXING CITY JIANGSU CAPSULE Ampoules •
PROVINCE BLISTER Tablets • Hard
Gelatin Capsules
330 NDA/MAL/H GULF GOODMAN CEFUZIME CEFUROXIM 125MG/5M GULF INDIA ORAL LIQUID 1.0X50.0 7/25/2018 GMP EXPIRED NONE
DP/8955 PHARMACEUTIC INTERNATIONAL E AXETIL L PHARMACEUTICAL ORDINARY ML BOTTLE ON 30-08-19
AL LTD INDUSTRIES DRY FOR NBL; SVP
INDUSTRIES(JUL (JULPHAR) -- SUSPENSION sol. & lyo.
PHAR) DIGDAGA, AIRPORT S/SYRUPS/DR powders for inj.,
STREET OPS Tabs, HGC, oral
RAS AL KHAIMAH susp powders,
UNITED ARAB Oral liquids
331 NDA/MAL/H GULF GAMA MEBOSCAR MULTINGRE N/A GULF UNITED TOPICAL 1.0X30.0 G 10/24/2017 GMP EXPIRED NONE
HP/8385 PHARMACEUTIC PHARMACEUTICA OINTMENT DIENT PHARMACEUTICAL ARAB EXTERNAL TUBE ON 30-08-19
AL LS (U) LIMITED INDUSTRIES EMIRATES OINTMENTS FOR NBL; SVP
INDUSTRIES(JUL (JULPHAR)-AIRPORT sol. & lyo.
PHAR). ROAD, powders for inj.,
DIGDAGA STREET Tabs, HGC, oral
RAS AL KHAIMAH susp powders,
Oral liquids
332 NDA/MAL/H CADILA ABACUS PHARMA AZICIN-500 AZITHROMY 500MG MAXHEAL INDIA ORAL SOLID 1.0X1.0X3.0 7/1/2009 FAILED GMP ON NONE
DP/2698 HEALTHCARE (AFRICA) LIMITED CIN PHARMACEUTICALS ORDINARY TABLET 14-05-2019 FOR
LTD INDIA LTD-J-7 MIDC, FILM- BLISTER Non beta-
TARAPUR INDUSTRIAL COATED lactam: Tablets
AREA, BOISAR- TABLETS (Coated and
401506, DIST.THANE, Uncoated),
MARAHASHTRA, External
INDIA preparations
333 NDA/MAL/H ABACUS ABACUS PHARMA NAZOL-200 KETOCONAZ 200MG MAXHEAL INDIA ORAL SOLID 1.0X10.0X1 7/1/2009 FAILED GMP ON KESAR PHARMA
DP/3431 PHARMA (A) (AFRICA) LIMITED OLE PHARMACEUTICALS ORDINARY 0.0 TABLET 14-05-2019 FOR PVT LTD-PLOT
LTD. INDIA LTD-J-7 MIDC, TABLETS BLISTER Non beta- SURVEY NO. 50-
TARAPUR INDUSTRIAL lactam: Tablets P2. AT VILLAGE
AREA, BOISAR- (Coated and BILESHWARPUR
401506, DIST.THANE, Uncoated), A, PO.
MARAHASHTRA, External CHHATRAL, TA.
INDIA preparations KALOL, DIST.
334 NDA/MAL/H ABACUS ABACUS PHARMA LEVOZIN LEVOCETIRI 5MG MAXHEAL INDIA ORAL SOLID 1.0X10.0X1 7/1/2008 FAILED GMP ON NONE
DP/3533 PHARMA (A) (AFRICA) LIMITED ZINE PHARMACEUTICALS ORDINARY 0.0 TABLET 14-05-2019 FOR
LTD. INDIA LTD-J-7 MIDC, FILM- BLISTER Non beta-
TARAPUR INDUSTRIAL COATED lactam: Tablets
AREA, BOISAR- TABLETS (Coated and
401506, DIST.THANE, Uncoated),
MARAHASHTRA, External
INDIA preparations
335 NDA/MAL/H ABACUS ABACUS PHARMA AC-FENAC ACECLOFEN 100MG MAXHEAL INDIA ORAL SOLID 1.0X3.0X10. 7/1/2008 FAILED GMP ON NONE
DP/3604 PHARMA LTD (AFRICA) LIMITED AC PHARMACEUTICALS ORDINARY 0 TABLET 14-05-2019 FOR
INDIA LTD-J-7 MIDC, FILM- BLISTER Non beta-
TARAPUR INDUSTRIAL COATED lactam: Tablets
AREA, BOISAR- TABLETS (Coated and
401506, DIST.THANE, Uncoated),
MARAHASHTRA, External
INDIA preparations
336 NDA/MAL/H ABACUS ABACUS PHARMA IBUPAR PARACETAM 325/400M MAXHEAL INDIA ORAL SOLID 1.0X10.0X1. 7/1/2008 FAILED GMP ON KESAR PHARMA
DP/3960 PHARMA (A) (AFRICA) LIMITED OL/IBUPROF G PHARMACEUTICALS ORDINARY 0X10.0 14-05-2019 FOR PVT LTD-PLOT
LTD. EN INDIA LTD-J-7 MIDC, TABLETS TABLET Non beta- SURVEY NO. 50-
TARAPUR INDUSTRIAL BLISTER lactam: Tablets P2. AT VILLAGE
AREA, BOISAR- (Coated and BILESHWARPUR
401506, DIST.THANE, Uncoated), A, PO.
MARAHASHTRA, External CHHATRAL, TA.
INDIA preparations KALOL, DIST.
337 NDA/MAL/H ABACUS ABACUS PHARMA AB-TONE VITAMIN B1 MG PER MAXHEAL INDIA ORAL LIQUID 1.0X1.0X20 7/1/2008 FAILED GMP ON NONE
DP/3980 PHARMA (A) (AFRICA) LIMITED TONIC + VITAMIN 5ML: 5 + 1 PHARMACEUTICALS ORDINARY 0.0 ML 14-05-2019 FOR
LTD. B2 + + 1 + 5 + 50 INDIA LTD-J-7 MIDC, SYRUPS BOTTLE,1.0 Non beta-
VITMAIN B6 + 2 + 20 + TARAPUR INDUSTRIAL X90.0 ML lactam: Tablets
+ VITAMIN 10 + 10 + 3 AREA, BOISAR- BOTTLE (Coated and
B12 + FOLIC + 0.2 + 0.25 401506, DIST.THANE, Uncoated),
ACID + + 20 + 100 MARAHASHTRA, External
VITAMIN B5 + 100 INDIA preparations
338 NDA/MAL/H ABACUS ABACUS PHARMA EXTRADOL PARACETAM 500MG/65 MAXHEAL INDIA ORAL SOLID 1.0X10.0X1 7/1/2008 FAILED GMP ON KESAR PHARMA
DP/3983 PHARMA (A) (AFRICA) LIMITED OL/CAFFEIN MG PHARMACEUTICALS ORDINARY 0.0 TABLET 14-05-2019 FOR PVT LTD-PLOT
LTD. E TABLETS INDIA LTD-J-7 MIDC, TABLETS BLISTER,1.0 Non beta- SURVEY NO. 50-
TARAPUR INDUSTRIAL X50.0X2.0 lactam: Tablets P2. AT VILLAGE
AREA, BOISAR- TABLET (Coated and BILESHWARPUR
401506, DIST.THANE, BLISTER Uncoated), A, PO.
MARAHASHTRA, External CHHATRAL, TA.
INDIA preparations KALOL, DIST.
339 NDA/MAL/H ABACUS ABACUS PHARMA MEFINAL- MEFENAMI 500MG MAXHEAL INDIA ORAL SOLID 1.0X10.0X1 7/1/2009 FAILED GMP ON NONE
DP/4712 PHARMA LTD (AFRICA) LIMITED 500 C ACID PHARMACEUTICALS ORDINARY 0.0 TABLET 14-05-2019 FOR
INDIA LTD-J-7 MIDC, TABLETS BLISTER Non beta-
TARAPUR INDUSTRIAL lactam: Tablets
AREA, BOISAR- (Coated and
401506, DIST.THANE, Uncoated),
MARAHASHTRA, External
INDIA preparations
340 NDA/MAL/H ALLY PHARMA ABACUS PHARMA FLOXCIP CIPROFLOXA 500MG MAXHEAL INDIA ORAL SOLID 1.0X10.0X1 7/1/2016 FAILED GMP ON NONE
DP/6187 OPTIONS PVT (AFRICA) LIMITED CIN PHARMACEUTICALS ORDINARY 0.0 TABLET 14-05-2019 FOR
LTD HYDROCHL INDIA LTD-J-7 MIDC, FILM- BLISTER Non beta-
ORIDE TARAPUR INDUSTRIAL COATED lactam: Tablets
AREA, BOISAR- TABLETS (Coated and
401506, DIST.THANE, Uncoated),
MARAHASHTRA, External
INDIA preparations
341 NDA/MAL/H UNEED GLOBAL ABACUS PHARMA WORMEE-4 ALBENDAZO 400MG MAXHEAL INDIA ORAL SOLID 1.0X1.0 7/1/2016 FAILED GMP ON KESAR PHARMA
DP/6189 GROUP LIMITED (AFRICA) LIMITED LE PHARMACEUTICALS ORDINARY TABLET 14-05-2019 FOR PVT LTD-PLOT
INDIA LTD-J-7 MIDC, CHEWABLE BLISTER Non beta- SURVEY NO. 50-
TARAPUR INDUSTRIAL TABLETS lactam: Tablets P2. AT VILLAGE
AREA, BOISAR- (Coated and BILESHWARPUR
401506, DIST.THANE, Uncoated), A, PO.
MARAHASHTRA, External CHHATRAL, TA.
INDIA preparations KALOL, DIST.
342 NDA/MAL/H UNEED GLOBAL ABACUS PHARMA NYSTATIN NYSTATIN 100,000 IU MAXHEAL INDIA VAGINAL 1.0X14.0 7/1/2016 FAILED GMP ON NONE
DP/6197 GROUP LIMITED (AFRICA) LIMITED PHARMACEUTICALS TABLETS PESSARY 14-05-2019 FOR
INDIA LTD-J-7 MIDC, STRIP Non beta-
TARAPUR INDUSTRIAL lactam: Tablets
AREA, BOISAR- (Coated and
401506, DIST.THANE, Uncoated),
MARAHASHTRA, External
INDIA preparations
343 NDA/MAL/H ALLY PHARMA ABACUS PHARMA PINPAC 50 DICLOFENA 50MG MAXHEAL INDIA ORAL SOLID 1.0X10.0X1 7/1/2016 FAILED GMP ON NONE
DP/6615 OPTIONS PVT (AFRICA) LIMITED C SODIUM PHARMACEUTICALS ORDINARY 0.0 TABLET 14-05-2019 FOR
LTD INDIA LTD-J-7 MIDC, ENTERIC- BLISTER Non beta-
TARAPUR INDUSTRIAL COATED lactam: Tablets
AREA, BOISAR- TABLETS (Coated and
401506, DIST.THANE, Uncoated),
MARAHASHTRA, External
INDIA preparations
344 NDA/MAL/H ABACUS ABACUS PHARMA MULTIVITAM VITAMIN 1600IU+10 MAXHEAL INDIA ORAL SOLID 1.0X1.0 9/2/2019 FAILED GMP ON NONE
DP/6910 PHARMA (A) (AFRICA) LIMITED IN TABLETS A+VITAMIN 0IU+1MG+ PHARMACEUTICALS ORDINARY TABLET 14-05-2019 FOR
LTD. D3+VITAMI 1MG+15M INDIA LIMITED-J-7, COATED BLISTER Non beta-
N G MIDC, TERAPUR TABLETS lactam: Tablets
B1+VITAMI INDUSTRIAL AREA, (Coated and
N B2+ BOISAR 401506 Uncoated),
NIACINAMI MAHARASHTRA External
DE preparations
345 NDA/MAL/H ABACUS ABACUS PHARMA PREDNIMAX PREDNISOL 5MG MAXHEAL INDIA ORAL SOLID 1.0X10.0X1 9/2/2019 FAILED GMP ON NONE
DP/7006 PHARMA (A) (AFRICA) LIMITED ONE PHARMACEUTICALS ORDINARY 0.0 TABLET 14-05-2019 FOR
LTD. INDIA LIMITED-J-7, TABLETS BLISTER Non beta-
MIDC, TERAPUR lactam: Tablets
INDUSTRIAL AREA, (Coated and
BOISAR 401506 Uncoated),
MAHARASHTRA External
preparations
346 NDA/MAL/H ABACUS ABACUS PHARMA CALCAC 300 CALCIUM 300MG MAXHEAL INDIA ORAL SOLID 1.0X10.0X1 9/2/2019 FAILED GMP ON NONE
DP/7010 PHARMA (A) (AFRICA) LIMITED LACTATE PHARMACEUTICALS ORDINARY 0.0 TABLET 14-05-2019 FOR
LTD. INDIA LIMITED-J-7, TABLETS BLISTER Non beta-
MIDC, TERAPUR lactam: Tablets
INDUSTRIAL AREA, (Coated and
BOISAR 401506 Uncoated),
MAHARASHTRA External
preparations
347 NDA/MAL/H ABACUS ABACUS PHARMA PROMETHAZI PROMETHA 25MG MAXHEAL INDIA ORAL SOLID 1.0X10.0X1 9/2/2019 FAILED GMP ON NONE
DP/7031 PHARMA (A) (AFRICA) LIMITED NE ZINE PHARMACEUTICALS ORDINARY 0.0 TABLET 14-05-2019 FOR
LTD. HYDROCHLO HYDROCHL INDIA LIMITED-J-7, TABLETS BLISTER Non beta-
RIDE ORIDE MIDC, TERAPUR lactam: Tablets
INDUSTRIAL AREA, (Coated and
BOISAR 401506 Uncoated),
MAHARASHTRA External
preparations
348 NDA/MAL/H ABACUS ABACUS PHARMA DIAHEAL LOPERAMID 2MG MAXHEAL INDIA ORAL SOLID 1.0X10.0X1 9/2/2019 FAILED GMP ON NONE
DP/7076 PHARMA (A) (AFRICA) LIMITED E PHARMACEUTICALS ORDINARY 0.0 14-05-2019 FOR
LTD. HYDROCHL INDIA LIMITED-J-7, CAPSULES CAPSULE Non beta-
ORIDE MIDC, TERAPUR BLISTER lactam: Tablets
INDUSTRIAL AREA, (Coated and
BOISAR 401506 Uncoated),
MAHARASHTRA External
preparations
349 NDA/MAL/H ABACUS ABACUS PHARMA HIFEN -200 IBUPROFEN 200MG MAXHEAL INDIA ORAL SOLID 1.0X10.0X1 11/28/2019 FAILED GMP ON NONE
DP/7340 PHARMA (A) (AFRICA) LIMITED PHARMACEUTICALS ORDINARY 0.0 TABLET 14-05-2019 FOR
LTD. INDIA LIMITED-J-7, COATED BLISTER Non beta-
MIDC, TERAPUR TABLETS lactam: Tablets
INDUSTRIAL AREA, (Coated and
BOISAR 401506 Uncoated),
MAHARASHTRA External
preparations
350 NDA/MAL/H M/S.MAXHEAL ABACUS PHARMA ZITHROHEAL AZITHROMY 500MG MAXHEAL INDIA ORAL SOLID 1.0X1.0X3.0 11/28/2019 FAILED GMP ON NONE
DP/7341 PHARMACEUTIC (AFRICA) LIMITED 500 CIN PHARMACEUTICALS ORDINARY TABLET 14-05-2019 FOR
ALS(INDIA) INDIA LIMITED-J-7, TABLETS BLISTER Non beta-
MIDC, TERAPUR lactam: Tablets
INDUSTRIAL AREA, (Coated and
BOISAR 401506 Uncoated),
MAHARASHTRA External
preparations
351 NDA/MAL/H MAXHEAL ABACUS PHARMA BUSCOPRIN HYOSCINE 10MG MAXHEAL INDIA ORAL SOLID 1.0X10.0X1 11/26/2019 FAILED GMP ON NONE
DP/9144 PHARMACEUTIC (AFRICA) LIMITED BUTYL PHARMACEUTICALS ORDINARY 0.0 TABLET 14-05-2019 FOR
ALS INDIA BROMIDE INDIA LIMITED-J-7, TABLETS BLISTER Non beta-
LIMITED, MIDC, TERAPUR lactam: Tablets
INDUSTRIAL AREA, (Coated and
BOISAR 401506 Uncoated),
MAHARASHTRA External
preparations
352 NDA/MAL/V QUALITY QUALITY ECOTIK DIP AMITRAZ 12.5%W/V MONTAJAT SOUTH TOPICAL 1.0X250.0 7/1/2003 GMP EXPIRED CEVA ANIMAL
DP/6835 CHEMICALS LTD CHEMICALS LTD - AND SPRAY VETERINARY AFRICA EXTERNAL ML ON 23/08/2019 HEALTH S.A,
VET PHARMACEUTICAL EMULSIONS BOTTLE,1.0 FOR •• SVP (PTY) LTD-NO. 8
CO. LTD X1.0 L solutions. • Oral MIFA
(AGROCHEMICALS BOTTLE,1.0 powders. • Oral INDUSTRIAL
DIVISION)-STREET 20, X100.0 ML liquids.(MONTA PARK, 399
2ND INDUSTRIAL CITY BOTTLE,1.0 NAJ) GEORGE ROAD,
P.O BOX 4248 X200.0 ML RANDJESPARK,
353 NDA/MAL/V ELANCO ERAM UGANDA AVIPRO® ND LIVE, NOT LESS MONTAJAT Saudi Arabia OTHER 1.0X10.0X1 1/13/2020 GMP EXPIRED NONE
DP/9159 ANIMAL HEALTH LIMITED VISOTA NEWCASTLE THAN VETERINARY SYSTEMIC 000.0 DOSE ON 23/08/2019
CO. DISEASE 10^5.5 PHARMACEUTICAL SPECIAL VIAL FOR •• SVP
LTD,DIVISION VACCINE, EID50 / CO. LTD (ANIMAL SOLIDS solutions. • Oral
OF ELI LILLY(SA) B1 TYPE, DOSE HEALTH DIVISION)- powders. • Oral
PTY,LTD LASOTA STREET 70, 2ND liquids.(MONTA
STRAIN INDUSTRIAL CITY NAJ)
354 NDA/MAL/V ELANCO ERAM UGANDA AVIPRO® FOWL POX NOT LESS MONTAJAT Saudi Arabia PARENTERAL 1.0X10.0X2 1/13/2020 GMP EXPIRED NONE
DP/9160 ANIMAL HEALTH LIMITED POX CEO VACCINE, THAN VETERINARY ORDINARY 500.0 DOSE ON 23/08/2019
CO. LIVE VIRUS 10^2.0 PHARMACEUTICAL VIALS VIAL FOR •• SVP
LTD,DIVISION EID50 CO. LTD (ANIMAL solutions. • Oral
OF ELI LILLY(SA) HEALTH DIVISION)- powders. • Oral
PTY,LTD STREET 70, 2ND liquids.(MONTA
INDUSTRIAL CITY NAJ)
355 NDA/MAL/V ELANCO ERAM UGANDA AVIPRO® ND- NEWCASTLE NOT LESS MONTAJAT Saudi Arabia OTHER 1.0X10.0X2 1/13/2020 GMP EXPIRED NONE
DP/9161 ANIMAL HEALTH LIMITED IB SOHOL DISEASE, B1 THAN VETERINARY SYSTEMIC 500.0 DOSE ON 23/08/2019
CO. TYPE, 10^5.5 PHARMACEUTICAL SPECIAL VIAL FOR •• SVP
LTD,DIVISION LASOTA EID50 + CO. LTD (ANIMAL SOLIDS solutions. • Oral
OF ELI LILLY(SA) STRAIN + NOT LESS HEALTH DIVISION)- powders. • Oral
PTY,LTD INFECTIOUS THAN STREET 70, 2ND liquids.(MONTA
BRONCHITIS 10^2.7 INDUSTRIAL CITY NAJ)
, MASS. EID50 /
356 NDA/MAL/H MSD (PTY) PHILLIPS AERIUS ORAL DESLORATA 0.5MG/ML MSD (PTY) LTD- BELGIUM ORAL LIQUID 1.0X1.0X60. 7/1/2007 GMP EXPIRED SCHERING-
DP/1853 LIMITED SA PHARMACEUTICA SOLUTION DINE LOCATED AT 117 16TH ORDINARY 0 ML ON THE PLOUGH LABO
LS (UGANDA) ROAD HALFWAY SYRUPS BOTTLE,1.0 22/08/2019 FOR N.V--INDUSTRIE
LIMITED HOUSE SOUTH AFRICA X150.0 ML NBL LINES; PARK 30, ZONE
BOTTLE Tablets Capsules A 2220 HEIST-OP-
Oral Liquids DEN-BERG
Powfers for Oral
suspension Oral
357 NDA/MAL/H MSD (PTY) PHILLIPS NASONEX MOMETASO 0.05%W/V MSD PTY LTD-117 BELGIUM NASAL 1.0X1.0X12 7/1/2009 GMP EXPIRED Schering Plough
DP/4173 LIMITED SA PHARMACEUTICA NE 16TH ROAD, SYSTEMIC 0.0 ON THE Labo N.V,-
LS (UGANDA) FUROATE HALFWAY HOUSE METERED- METERED 22/08/2019 FOR industry park 30,
LIMITED MONOHYDR 1685 DOSE DOSE NBL LINES; 2220 heist
ATE LIQUIDS CANNISTER Tablets Capsules opdenberg
Oral Liquids belgium
Powfers for Oral
suspension Oral
358 NDA/MAL/H MSD (PTY) PHILLIPS DIPROFOS BETAMETHA 2MG + MSD (PTY) LTD- BELGIUM PARENTERAL 1.0X2.0 ML 7/1/2001 43767 SCHERING-
DP/5256 LIMITED SA PHARMACEUTICA INJECTION SONE 5MG/ML LOCATED AT 117 16TH ORDINARY AMPOULE PLOUGH LABO
LS (UGANDA) DISODIUM ROAD HALFWAY AMPOULES N.V--INDUSTRIE
LIMITED PHOSPHATE HOUSE SOUTH AFRICA PARK 30, ZONE
+ A 2220 HEIST-OP-
BETAMETHA DEN-BERG
SONE
DIPROPION
359 NDA/MAL/H MSD (PTY) PHILLIPS ELOCOM MOMETASO 0.1%W/V MSD (PTY) LTD- CANADA TOPICAL 1.0X30.0 7/1/2000 GMP EXPIRED SCHERING
DP/5293 LIMITED SA PHARMACEUTICA LOTION NE LOCATED AT 117 16TH EXTERNAL ML BOTTLE ON THE PLOUGH
LS (UGANDA) FUROATE ROAD HALFWAY LOTIONS 22/08/2019 FOR CORPORATION-
LIMITED HOUSE SOUTH AFRICA NBL LINES; POINTE CLAIRE
Tablets Capsules QUEBEC
Oral Liquids
Powfers for Oral
suspension Oral
360 NDA/MAL/H MSD (PTY) PHILLIPS CELESTAMIN BETAMETHA 0.25MG + MSD (PTY) LTD- BELGIUM ORAL SOLID 1.0X30.0 7/1/2001 GMP EXPIRED SCHERING
DP/5349 LIMITED SA PHARMACEUTICA E TABLETS SONE + 2MG LOCATED AT 117 16TH ORDINARY TABLET ON THE PLOUGH LABO
LS (UGANDA) DEXCHLORP ROAD HALFWAY TABLETS BOTTLE 22/08/2019 FOR N.V,-INDUSTRY
LIMITED HENIRAMIN HOUSE SOUTH AFRICA NBL LINES; PARK 30, 2220
E Tablets Capsules HEIST
Oral Liquids OPDENBERG
Powfers for Oral BELGIAM
suspension Oral
361 NDA/MAL/H MSD (PTY) PHILLIPS AERIUS DESLORATID 5MG MSD (PTY) LTD- CANADA ORAL SOLID 1.0X2.0X15. 7/1/2001 GMP EXPIRED SCHERING
DP/5444 LIMITED SA PHARMACEUTICA TABLETS INE LOCATED AT 117 16TH ORDINARY 0 TABLET ON THE PLOUGH LABO
LS (UGANDA) ROAD HALFWAY TABLETS BLISTER 22/08/2019 FOR NV-INDUSTRIE
LIMITED HOUSE SOUTH AFRICA NBL LINES; PARK 30, ZONE
Tablets Capsules A, 2220, HEIST
Oral Liquids OP-DEN-BERG
Powfers for Oral
suspension Oral
362 NDA/MAL/H MSD (PTY) LTD PHILLIPS ISENTRESS RALTEGRAVI 25MG PATHEON UNITED ORAL SOLID 1.0X1.0X60. 3/28/2018 FOR MSD - GMP NONE
DP/7348 PHARMACEUTICA 25 MG R PHARMACEUTICALS STATES ORDINARY 0 TABLET EXPIRED ON THE
LS (UGANDA) POTASSIUM INC.-2110 E. CHEWABLE BOTTLE 22/08/2019 FOR
LIMITED GALBRAITH ROAD TABLETS NBL LINES;
CINCINNATI, OH Tablets Capsules
45237-1625, USA Oral Liquids
MERCK SHARP & Powfers for Oral
DOHME BV.- suspension Oral
363 NDA/MAL/H MSD (PTY) LTD PHILLIPS JANUVIA 25 SITAGLIPTIN 25MG MSD PTY LTD-117 SOUTH ORAL SOLID 1.0X2.0X14. 7/1/2017 GMP EXPIRED NONE
DP/7651 PHARMACEUTICA 16TH ROAD, AFRICA ORDINARY 0 TABLET ON THE
LS (UGANDA) HALFWAY HOUSE FILM- BLISTER 22/08/2019 FOR
LIMITED 1685 COATED NBL LINES;
TABLETS Tablets Capsules
Oral Liquids
Powfers for Oral
suspension Oral
364 NDA/MAL/H MSD (PTY) LTD PHILLIPS JANUVIA 100 SITAGLIPTIN 100MG MSD PTY LTD-117 SOUTH ORAL SOLID 1.0X2.0X14. 7/1/2017 GMP EXPIRED NONE
DP/7652 PHARMACEUTICA 16TH ROAD, AFRICA ORDINARY 0 TABLET ON THE
LS (UGANDA) HALFWAY HOUSE FILM- BLISTER 22/08/2019 FOR
LIMITED 1685 COATED NBL LINES;
TABLETS Tablets Capsules
Oral Liquids
Powfers for Oral
suspension Oral
365 NDA/MAL/H MSD (PTY) LTD PHILLIPS JANUVIA 50 SITAGLIPTIN 50MG MSD PTY LTD-117 SOUTH ORAL SOLID 1.0X2.0X14. 7/1/2017 GMP EXPIRED NONE
DP/7653 PHARMACEUTICA 16TH ROAD, AFRICA ORDINARY 0 TABLET ON THE
LS (UGANDA) HALFWAY HOUSE FILM- BLISTER 22/08/2019 FOR
LIMITED 1685 COATED NBL LINES;
TABLETS Tablets Capsules
Oral Liquids
Powfers for Oral
suspension Oral
366 NDA/MAL/H MSD (PTY) LTD PHILLIPS ISENTRESS RALTEGRAVI 100MG PATHEON UNITED ORAL SOLID 1.0X1.0X60. 3/28/2018 FOR MSD - GMP NONE
DP/8639 PHARMACEUTICA 100MG R PHARMACEUTICALS STATES ORDINARY 0 TABLET EXPIRED ON THE
LS (UGANDA) POTASSIUM INC.-2110 E. CHEWABLE BOTTLE 22/08/2019 FOR
LIMITED GALBRAITH ROAD TABLETS NBL LINES;
CINCINNATI, OH Tablets Capsules
45237-1625, USA Oral Liquids
MERCK SHARP & Powfers for Oral
DOHME BV.- suspension Oral
367 NDA/MAL/H MOONLINK MOONLINK NEOPROFAN IBUPROFEN 400 MG JIANGSU PENGYAO CHINA ORAL SOLID 1.0X10.0X1 1/31/2018 FAILED GMP ON NONE
DP/8323 PHARMACEUTIC PHARMACEUTICA E 400 PHARMACEUTICALS ORDINARY 0.0 TABLET 2018-08-28 FOR
ALS LTD LS LTD CO. LTD-NO. 10 FILM- BLISTER Non Beta
CHAQUAN COATED Lactam: • SVP-
ROAD,YIXING CITY, TABLETS Solutions in
CHINA Ampoules •
Tablets • Hard
Gelatin Capsules
368 NDA/MAL/H I CARE PHARMA VITACARE LTD GENTAMYCI GENTAMYCI 0.3%W/V GRAND CHINA OPHTHALMI 1.0X1.0X10. 7/1/2013 FACILITY NO NONE
DP/5009 LIMITED N N PHARMACEUTICAL(CH C DROPS 0 ML VIAL LONGER EXISTS
INA) CO.LTD-NO.5
GUTIAN ROAD
QIAOKOU DISTRICT
WUHAN CITY HUBEI
PROVINCE
369 NDA/MAL/H ASTRA PHARMA ASTRA PHARMA INDOMETACI INDOMETH 25MG ZHEJIANG RUIXIN CHINA ORAL SOLID 1000.0 7/1/2002 FAILED GMP ON NONE
DP/5328 (UK) LTD (U) LIMITED N 25MG ACIN PHARMACEUTICAL ORDINARY CAPSULE 8TH,9TH AND
CAPSULES BP CO. LTD-KAIFA ROAD, CAPSULES CONTAINER 12TH Aug 2019
LISHUI, ZHEJIANG P.R ,1.0X100.0X for
OF CHINA 10.0 NBL(Tablets,Cap
CAPSULE sules and SVP
BLISTER,1.0 liquids),Hormon
X10.0X10.0 es(SVPs),Cephal
370 NDA/MAL/H YURIA PHARM YURIA PHARM INFULGAN PARACETAM 10MG/ML YURIA-PHARM, LTD.- UKRAINE PARENTERAL 1.0X100.0 7/1/2013 GMP expired on NONE
DP/1938 EAST AFRICA EAST AFRICA OL 18030 ORDINARY ML 02-08-2019 FOR -
LIMITED LIMITED VERBOVETSKOGO STR. INFUSION BOTTLE,1.0 Small Volume
108 CHERKASSY, VIALS/BOTTL X20.0 ML Parenterals -
UKRAINE. ES BOTTLE Large Volume
Parenterals -
Oral Liquids
371 NDA/MAL/H YURIA PHARM YURIA PHARM AMINOL AMINO 200MG/ML YURIA-PHARM, LTD- UKRAINE PARENTERAL 1.0X200.0 7/1/2013 GMP expired on NONE
DP/0313 EAST AFRICA EAST AFRICA ACIDS 108, ORDINARY ML 02-08-2019 FOR -
LIMITED LIMITED VERBOVETSKOGO INFUSION VIAL,1.0X40 Small Volume
STREET CHERKASSY, BAGS 0.0 ML VIAL Parenterals -
18030, UKRAINE Large Volume
Parenterals -
Oral Liquids
372 NDA/MAL/H I CARE PHARMA VITACARE LTD QUININE QUININE 600MG/2M GRAND CHINA PARENTERAL 1.0X10.0X2. 7/1/2013 FAILED GMP ON NONE
DP/5477 LIMITED DIHYDROCHL DIHYDROCH L PHARMACEUTICAL ORDINARY 0 ML 14th,15th and
ORIDE LORIDE (CHINA) CO. LTD- AMPOULES AMPOULE 16th August
INJECTION CHINA 2019 FOR NBL •
Tablets (Coated
and Uncoated) •
Hard Gelatin
Capsules • SVP
373 NDA/MAL/H GLENMARK STAR ASCORIL LS LEVOSALBU 1 MG + 30 GLENMARK INDIA ORAL LIQUID 1.0X1.0X10 3/27/2019 GMP EXPIRED NONE
DP/6424 PHARMACEUTIC PHARMACEUTICA TAMOL MG + 100 PHARMACEUTICALS ORDINARY 0.0 ML ON 20/12/2014
ALS LTD LS LTD SULPHATE + MG LTD .-VILLAGE LIQUIDS BOTTLE FOR Tablets
AMBROXOL KISHANPURA, BADDI- Capsules Oral
HYDROCHL NALAGARH ROAD, Liquids
ORIDE + TEHSIL BADDI, Ointments,
GUAIFENESI DISTRICT SOLAN HP Creams &
N 173205 Lotions, Metered
374 NDA/MAL/H GLAXO SMITH UNITED DUODART DUTASTERI 0.5MG + Catalent Germany Germany Oral Solid 1.0x30.0 2015-07-01 GMP expired on NONE
DP/0576 KLINE LTD HEALTHCARE DE + 0.4MG Schondorf GmbH - Ordinary CAPSULE 2020-05-15 FOR -
DISTRIBUTORS TAMSULOSI Steinbeisstrasse 1-2, Capsules Container Hard Gelatin
LTD N 73614 Schorndorf, Capsules
Germany
375 NDA/MAL/H ZIFAM BOOTS KIT LANZ LANSOPRAZ 30MG + FREDUN INDIA ORAL SOLID 1.0X7.0X6.0 8/28/2019 FAILED GMP NONE
DP/6981 PINNACLE PTY. PHARMACEUTICA OLE + 250MG + PHARMACEUTICALS ORDINARY TABLET
LTD. LS LIMITED CLARITHRO 500MG LIMITED-14,15,16, OTHER BLISTER
MYCIN + ZORABIAN SPECIAL PACK HAS
TINIDAZOLE INDUSTRIAL FORMS BOTH
COMPLEX,VEOOR,PAL CAPSULES
GHAR (E), DIST: AND
PALGHAR-401 404 TABLETS
376 NDA/MAL/H PLANET PLANET FREMOL PARACETAM 500MG + FREDUN INDIA ORAL SOLID 1.0X10.0X1 11/27/2019 FAILED GMP NONE
DP/7095 PHARMACEUTIC PHARMACEUTICA EXTRA OL + 65MG PHARMACEUTICALS ORDINARY 0.0 TABLET
ALS UGANDA LS UGANDA LTD CAFFEINE LIMITED-14,15,16, TABLETS BLISTER
LTD ZORABIAN
INDUSTRIAL
COMPLEX,VEOOR,PAL
GHAR (E), DIST:
PALGHAR-401 404
377 NDA/MAL/H INFUGEN TATA UGANDA PAPILON AC ACECLOFEN 100MG FREDUN INDIA ORAL SOLID 1.0X10.0X1 2/4/2019 FAILED GMP NONE
DP/7160 PHARMA PVT. LIMITED AC PHARMACEUTICALS ORDINARY 0.0 TABLET
LTD. LIMITED-14,15,16, TABLETS BLISTER
ZORABIAN
INDUSTRIAL
COMPLEX,VEOOR,PAL
GHAR (E), DIST:
PALGHAR-401 404
378 NDA/MAL/H FREDUN PLANET FREMOL PARACETAM 500MG + FREDUN INDIA ORAL SOLID 1.0X50.0X1. 7/25/2018 FAILED GMP NONE
DP/8939 PHARMACEUTIC PHARMACEUTICA PLUS OL + 10MG + PHARMACEUTICALS ORDINARY 0X4.0
ALS LTD LS UGANDA LTD PHENYLEPH 2MG + LTD --14, 15, 16, TABLETS TABLET
RINE 30MMG ZORABIAN BLISTER
HYDROCHL INDUSTRIAL
ORIDE + COMPLEX,
CHLORPHEN VILLAGE, VEOOR,
IRAMINE PALGHAR (EAST)
379 NDA/MAL/H USV PRIVATE ABACUS PHARMA DUOTROL GLYBURIDE 5MG + FREDUN INDIA ORAL SOLID 1.0X10.0X1 7/1/2005 FAILED GMP NONE
DP/5307 LIMITED (AFRICA) LIMITED + 500MG PHARMACEUTICALS ORDINARY 0.0 TABLET
METFORMI LIMITED---14,15,16 TABLETS BLISTER
N ZORABIAN
HYDROCHL INDUSTRIAL COMPLEX
ORIDE PALAGHAR (EAST),
DIST THANE 401 404
INDIA
380 NDA/MAL/H FREDUN PLANET H-CURE LANSOPRAZ 30MG + FREDUN INDIA ORAL SOLID 1.0X7.0X6.0 7/1/2016 FAILED GMP NONE
DP/6232 PHARMACEUTIC PHARMACEUTICA OLE + 250MG + PHARMACEUTICALS ORDINARY TABLET
ALS LTD LS UGANDA LTD CLARITHRO 500MG LTD-VEOOR PALGHAR TABLETS BLISTER
MYCIN + ( E ) 401 404 (BLISTER
TINIDAZOLE CONTAINS
2CAPSULES
OF
LANSOPRAZ
381 NDA/MAL/H MOONLINK PLANET FREMOL PARACETAM 325 MG + FREDUN INDIA ORAL SOLID 1.0X40.0X2. 7/1/2016 FAILED GMP NONE
DP/6236 PHARMACEUTIC PHARMACEUTICA ADVANCE OL + 400 MG + PHARMACEUTICALS ORDINARY 0X10.0
ALS LTD LS UGANDA LTD IBUPROFEN 40 MG LTD-VEOOR PALGHAR CAPSULES CAPSULE
+ CAFFEINE ( E ) 401 404 BLISTER

382 NDA/MAL/H ZIFAM BOOTS AZIFAM DS AZITHROMY 200MG/5M FREDUN INDIA ORAL LIQUID 1.0X1.0X15. 3/28/2019 FAILED GMP NONE
DP/6387 PINNACLE PTY. PHARMACEUTICA CIN L PHARMACEUTICALS ORDINARY 0 ML
LTD. LS LIMITED LIMITED-14,15,16, DRY BOTTLE
ZORABIAN SUSPENSION
INDUSTRIAL S/SYRUPS/DR
COMPLEX,VEOOR,PAL OPS
GHAR (E), DIST:
PALGHAR-401 404
383 NDA/MAL/H ZIFAM BOOTS ZIFAM GRIS GRISEOFULV 500 MG FREDUN INDIA ORAL SOLID 1.0X10.0X1 3/27/2019 FAILED GMP NONE
DP/6486 PINNACLE PTY. PHARMACEUTICA 500 IN PHARMACEUTICALS ORDINARY 0.0 TABLET
LTD. LS LIMITED LIMITED-14,15,16, TABLETS BLISTER
ZORABIAN
INDUSTRIAL
COMPLEX,VEOOR,PAL
GHAR (E), DIST:
PALGHAR-401 404
384 NDA/MAL/H ZIFAM BOOTS AZIFAM 250 AZITHROMY 250MG FREDUN INDIA ORAL SOLID 1.0X10.0X6. 5/29/2019 FAILED GMP NONE
DP/6494 PINNACLE PTY. PHARMACEUTICA CIN PHARMACEUTICALS ORDINARY 0 CAPSULE
LTD. LS LIMITED LIMITED-14,15,16, CAPSULES BLISTER
ZORABIAN
INDUSTRIAL
COMPLEX,VEOOR,PAL
GHAR (E), DIST:
PALGHAR-401 404
385 NDA/MAL/H ZIFAM BOOTS AZIFAM 500 AZITHROMY 500 MG FREDUN INDIA ORAL SOLID 1.0X10.0X1 8/28/2019 FAILED GMP NONE
DP/6583 PINNACLE LTD PHARMACEUTICA CIN PHARMACEUTICALS ORDINARY 0.0
LS LIMITED LIMITED-14,15,16, CAPSULES CAPSULE
ZORABIAN BLISTER
INDUSTRIAL
COMPLEX,VEOOR,PAL
GHAR (E), DIST:
PALGHAR-401 404
386 NDA/MAL/H ZIFAM BOOTS ZIFLODIP 5 AMLODIPIN 5 MG FREDUN INDIA ORAL SOLID 1.0X10.0X1 8/28/2019 FAILED GMP NONE
DP/6584 PINNACLE LTD PHARMACEUTICA E BESYLATE PHARMACEUTICALS ORDINARY 0.0 TABLET
LS LIMITED LIMITED-14,15,16, TABLETS BLISTER
ZORABIAN
INDUSTRIAL
COMPLEX,VEOOR,PAL
GHAR (E), DIST:
PALGHAR-401 404
387 NDA/MAL/H ZIFAM BOOTS ZIFLODIP 10 AMLODIPIN 10 MG FREDUN INDIA ORAL SOLID 1.0X10.0X1 8/28/2019 FAILED GMP NONE
DP/6585 PINNACLE PTY. PHARMACEUTICA E BESYLATE PHARMACEUTICALS ORDINARY 0.0 TABLET
LTD. LS LIMITED LIMITED-14,15,16, TABLETS BLISTER
ZORABIAN
INDUSTRIAL
COMPLEX,VEOOR,PAL
GHAR (E), DIST:
PALGHAR-401 404
388 NDA/MAL/H FREDUN PLANET FREMOL PARACETAM 500MG FREDUN INDIA ORAL SOLID 1.0X10.0X1 7/1/1999 FAILED GMP NONE
DP/0776 PHARMACEUTIC PHARMACEUTICA TABLETS OL TABLETS PHARMACEUTICALS ORDINARY 0.0 TABLET
ALS LTD LS UGANDA LTD LTD-14,15,16 TABLETS BLISTER,1.0
ZORBIAN INDUSTRIAL X1000.0
COMPLEX VEOOR TABLET
PALGHAR EAST INDIA CONTAINER

389 NDA/MAL/H USV PRIVATE ABACUS PHARMA GLYCOMET METFORMI 850MG FREDUN INDIA ORAL SOLID 1.0X10.0X1 7/1/2000 FAILED GMP NONE
DP/2151 LIMITED (AFRICA) LIMITED 850 N PHARMACEUTICALS ORDINARY 0.0 TABLET
LIMITED---14,15,16 TABLETS BLISTER
ZORABIAN
INDUSTRIAL COMPLEX
PALAGHAR (EAST),
DIST THANE 401 404
INDIA
390 NDA/MAL/H ABACUS ABACUS PHARMA GLYNASE GLIPIZIDE 5MG FREDUN INDIA ORAL SOLID 1.0X10.0X1 7/1/2000 FAILED GMP NONE
DP/2154 PHARMA (AFRICA) LIMITED PHARMACEUTICALS ORDINARY 0.0 TABLET
(AFRICA) LIMITED---14,15,16 TABLETS BLISTER
LIMITED ZORABIAN
INDUSTRIAL COMPLEX
PALAGHAR (EAST),
DIST THANE 401 404
INDIA
391 NDA/MAL/H USV PRIVATE ABACUS PHARMA GLYCOMET METFORMI 500MG FREDUN INDIA ORAL SOLID 1.0X10.0X1 7/1/2000 FAILED GMP NONE
DP/2970 LIMITED (AFRICA) LIMITED 500 N PHARMACEUTICALS ORDINARY 0.0 TABLET
LIMITED---14,15,16 TABLETS BLISTER
ZORABIAN
INDUSTRIAL COMPLEX
PALAGHAR (EAST),
DIST THANE 401 404
INDIA
392 NDA/MAL/H NORVATIS LABOREX CILOXAN CIPROFLOXA 0.3%W/V ALCON -ALCON BELGIUM OPHTHALMI 1.0X5.0 ML 7/1/1997 GMP EXPIRED NONE
DP/4738 PHARMA AG- UGANDA CIN COUVREUR NV B-2870 C DROPS BOTTLE ON 2020-04-03
SWITZERLAND LIMITED PUURS BELGIUM FOR Aseptically
prepared semi
solids
(Ointments) Eye
drops
393 NDA/MAL/H NORVATIS LABOREX BETOPTIC BETAXOLOL O.5%W/V ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 ML 7/1/1997 GMP EXPIRED NONE
DP/3331 PHARMA AG- UGANDA RIJKSWEG 14, B-2870 C DROPS VIAL ON 2020-04-03
SWITZERLAND LIMITED PUURS BELGIUM FOR Aseptically
prepared semi
solids
(Ointments) Eye
drops
394 NDA/MAL/H NORVATIS LABOREX TOBRADEX TOBRAMYCI 0.3%W/V+ ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 ML 7/1/1997 GMP EXPIRED NONE
DP/4060 PHARMA AG- UGANDA N/DEXAMET 0.1%W/V RIJKSWEG 14, B-2870 C DROPS BOTTLE ON 2020-04-03
SWITZERLAND LIMITED HASONE PUURS BELGIUM FOR Aseptically
prepared semi
solids
(Ointments) Eye
drops
395 NDA/MAL/H NORVATIS LABOREX DUOTRAV TRAVOPROS 40MG/ML ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X1.0X2.5 7/1/2010 GMP EXPIRED NONE
DP/4650 PHARMA AG- UGANDA T+ + 5MG/ML RIJKSWEG 14, B-2870 C DROPS ML VIAL ON 2020-04-03
SWITZERLAND LIMITED TIMOLOL PUURS BELGIUM FOR Aseptically
MALEATE prepared semi
solids
(Ointments) Eye
drops
396 NDA/MAL/H NORVATIS LABOREX AZOPT BRINZOLAM 10MG/ML ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 ML 7/1/2009 GMP EXPIRED NONE
DP/4927 PHARMA AG- UGANDA IDE RIJKSWEG 14, B-2870 C BOTTLE ON 2020-04-03
SWITZERLAND LIMITED PUURS BELGIUM SUSPENSION FOR Aseptically
S prepared semi
solids
(Ointments) Eye
drops
397 NDA/MAL/H NORVATIS LABOREX MAXITROL DEXAMETH 0.1%W/W ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X3.5 G 7/1/1997 GMP EXPIRED NONE
DP/5041 PHARMA AG- UGANDA ASONE/NEO +0.1%W/W RIJKSWEG 14, B-2870 C TUBE ON 2020-04-03
SWITZERLAND LIMITED MYCIN/POL +6000 I.U PUURS BELGIUM OINTMENTS FOR Aseptically
YMYXIN B prepared semi
solids
(Ointments) Eye
drops
398 NDA/MAL/H NORVATIS LABOREX MAXITROL DEXAMETH 0.1%W/W+ ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 ML 7/1/1997 GMP EXPIRED NONE
DP/5043 PHARMA AG- UGANDA ASONE/NEO 3500I.U/M RIJKSWEG 14, B-2870 C DROPS BOTTLE ON 2020-04-03
SWITZERLAND LIMITED MYCIN/POL L+6000I.U/ PUURS BELGIUM FOR Aseptically
YMYXIN B ML prepared semi
solids
(Ointments) Eye
drops
399 NDA/MAL/H NORVATIS LABOREX MAXIDEX DEXAMETH 0.1%W/V ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 ML 7/1/1997 GMP EXPIRED NONE
DP/5050 PHARMA AG- UGANDA ASONE RIJKSWEG 14, B-2870 C DROPS BOTTLE ON 2020-04-03
SWITZERLAND LIMITED PUURS BELGIUM FOR Aseptically
prepared semi
solids
(Ointments) Eye
drops
400 NDA/MAL/H NORVATIS LABOREX AZARGA BRINZOLAM 10MG/ML ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 ML 7/1/2010 GMP EXPIRED NONE
DP/0572 PHARMA AG- UGANDA IDE + + 5MG/ML RIJKSWEG 14, B-2870 C DROPS VIAL ON 2020-04-03
SWITZERLAND LIMITED TIMOLOL PUURS BELGIUM FOR Aseptically
prepared semi
solids
(Ointments) Eye
drops
401 NDA/MAL/H ALCON KARURI TEARS NATURAL 15ML ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X15.0 7/1/1997 GMP EXPIRED NONE
DP/1738 PHARMACEUTIC PHARMACEUTICA NATURALE II TEARS RIJKSWEG 14, B-2870 C DROPS ML BOTTLE ON 2020-04-03
ALS LS LTD. PUURS BELGIUM FOR Aseptically
prepared semi
solids
(Ointments) Eye
drops
402 NDA/MAL/H NORVATIS LABOREX PATANOL OLOPATADI 0.1%W/V ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 ML 7/1/2009 GMP EXPIRED NONE
DP/1864 PHARMA AG- UGANDA NE RIJKSWEG 14, B-2870 C DROPS VIAL ON 2020-04-03
SWITZERLAND LIMITED HYDROCHL PUURS BELGIUM FOR Aseptically
ORIDE prepared semi
solids
(Ointments) Eye
drops
403 NDA/MAL/H NORVATIS LABOREX TOBREX TOBRAMYCI 0.3%W/V ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X5.0 ML 7/1/1997 GMP EXPIRED NONE
DP/2545 PHARMA AG- UGANDA N RIJKSWEG 14, B-2870 C DROPS BOTTLE ON 2020-04-03
SWITZERLAND LIMITED PUURS BELGIUM FOR Aseptically
prepared semi
solids
(Ointments) Eye
drops
404 NDA/MAL/H NORVATIS LABOREX TRAVATAN TRAVOPROS 4µG/ML ALCON COUVREUR NV- BELGIUM OPHTHALMI 1.0X2.5 ML 7/1/2009 GMP EXPIRED NONE
DP/2974 PHARMA AG- UGANDA T RIJKSWEG 14, B-2870 C DROPS VIAL ON 2020-04-03
SWITZERLAND LIMITED PUURS BELGIUM FOR Aseptically
prepared semi
solids
(Ointments) Eye
drops
405 NDA/MAL/H CIRON DRUGS & RENE PHARMACY CIROZEP DIAZEPAM 5MG/ML
CIRON DRUGS & INDIA PARENTERAL 1.0X10.0X1 7/1/2013 GMP EXPIRED NONE
DP/5380 PHARMACEUTIC LTD PHARMACEUTICALS ORDINARY 0.0X2.0 ML ON 2020-05-30
ALS PVT LTD PVT LTD .-N- AMPOULES AMPOULE FOR Non-beta
118,M.I.D.C, lactam • SVP
TARAPUR,BOISAR, injections
DIST.THANE-401506, (Ampoules,
MAHARASHTRA,INDIA Vials) • SVP
. (Lyophilized) •
406 NDA/MAL/H CIRON DRUGS RENE PHARMACY METOCLOPR METOCLOP 5MG/ML CIRON DRUGS & INDIA PARENTERAL 1.0X10.0X1 7/1/2010 GMP EXPIRED NONE
DP/1167 AND LTD AMIDE RAMIDE PHARMACEUTICALS ORDINARY 0.0X2.0 ML ON 2020-05-30
PHARMACEUTIC INJECTION PVT LTD .-N- AMPOULES AMPOULE FOR Non-beta
ALS PVT LTD 118,M.I.D.C, lactam • SVP
TARAPUR,BOISAR, injections
DIST.THANE-401506, (Ampoules,
MAHARASHTRA,INDIA Vials) • SVP
. (Lyophilized) •
407 NDA/MAL/H CIRON DRUGS RENE PHARMACY LIDOCAINE LIDOCAINE 20MG/ML CIRON DRUGS & INDIA PARENTERAL 1.0X20.0 7/1/2010 GMP EXPIRED NONE
DP/1172 AND LTD HYDROCHLO HYDROCHL PHARMACEUTICALS ORDINARY ML ON 2020-05-30
PHARMACEUTIC RIDE ORIDE PVT LTD .-N- VIALS VIAL,1.0X30 FOR Non-beta
ALS PVT LTD 118,M.I.D.C, .0 ML VIAL lactam • SVP
TARAPUR,BOISAR, injections
DIST.THANE-401506, (Ampoules,
MAHARASHTRA,INDIA Vials) • SVP
. (Lyophilized) •
408 NDA/MAL/H CIRON DRUGS ROYAL PHARMA CIROPAIN DICLOFENA 1%W/W CIRON DRUGS & INDIA TOPICAL 1.0X20.0 G 7/1/2017 GMP EXPIRED NONE
DP/6548 & 2011 LIMITED GEL C PHARMACEUTICALS EXTERNAL TUBE ON 2020-05-30
PHARMACEUTIC DIETHYLAMI PVT LTD--N-118, 119 GELS AND FOR Non-beta
AL PVT LTD NE BP MIDC TARAPUR SOLS lactam • SVP
BOISAR DIST THANE injections
4011 506 (Ampoules,
Vials) • SVP
(Lyophilized) •
409 NDA/MAL/H CIRON DRUGS RENE PHARMACY CENTROZINE CETIRIZINE 5MG/5ML CIRON DRUGS & INDIA ORAL LIQUID 1.0X60.0 7/1/2017 GMP EXPIRED NONE
DP/8201 AND LTD HYDROCHL PHARMACEUTICALS ORDINARY ML BOTTLE ON 2020-05-30
PHARMACEUTIC ORIDE PVT LTD--N-118, 119 SYRUPS FOR Non-beta
ALS PVT LTD MIDC TARAPUR lactam • SVP
BOISAR DIST THANE injections
4011 506 (Ampoules,
Vials) • SVP
(Lyophilized) •
410 NDA/MAL/H CIRON DRUGS & RENE PHARMACY HYDROCORTI HYDROCOR 100MG CIRON DRUGS & INDIA PARENTERAL 1.0X50.0X1 7/1/2007 GMP EXPIRED NONE
DP/8210 PHARMACEUTIC LTD SONE TISONE PHARMACEUTICALS ORDINARY 00.0 MG ON 2020-05-30
ALS PVT LTD SODIUM PVT LTD--N-118, 119 DRY VIALS VIAL FOR Non-beta
SUCCINATE MIDC TARAPUR lactam • SVP
FOR BOISAR DIST THANE injections
INJECTION 4011 506 (Ampoules,
BP Vials) • SVP
(Lyophilized) •
411 NDA/MAL/H CIRON DRUGS & RENE PHARMACY COLD PLUS PARACETAM 125MG + CIRON DRUGS & INDIA ORAL LIQUID 1.0X100.0 7/1/2014 GMP EXPIRED NONE
DP/2923 PHARMACEUTIC LTD SYRUP OL + 2.5MG + PHARMACEUTICALS ORDINARY ML BOTTLE ON 2020-05-30
ALS PVT LTD PHENYLEPH 2.5MG/ PVT LTD--N-118, 119 SYRUPS FOR Non-beta
RINE 5ML MIDC TARAPUR lactam • SVP
HYDROCHL BOISAR DIST THANE injections
ORIDE + 4011 506 (Ampoules,
CHLORPHEN Vials) • SVP
IRAMINE (Lyophilized) •
412 NDA/MAL/H CIRON DRUGS & RENE PHARMACY CIROGAN PROMETHA 25MG/ML CIRON DRUGS & INDIA PARENTERAL 1.0X10.0X1 7/1/2011 GMP EXPIRED NONE
DP/3635 PHARMACEUTIC LTD ZINE PHARMACEUTICALS ORDINARY 0.0X2.0 ML ON 2020-05-30
ALS PVT LTD HYDROCHL PVT LTD-N-118, N-119 AMPOULES AMPOULE FOR Non-beta
ORIDE MIDC TARAPUR lactam • SVP
BOISAR DIST THANE injections
401506 (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
413 NDA/MAL/H CIRON DRUGS & RENE PHARMACY CHLORPROM CHLORPRO 25MG/ML CIRON DRUGS & INDIA PARENTERAL 1.0X10.0X1 7/1/2011 GMP EXPIRED NONE
DP/3873 PHARMACEUTIC LTD AZINE MAZINE PHARMACEUTICALS ORDINARY 0.0X2.0 ML ON 2020-05-30
ALS PVT LTD INJECTION PVT LTD-N-118, N-119 AMPOULES AMPOULE FOR Non-beta
B.P MIDC TARAPUR lactam • SVP
BOISAR DIST THANE injections
401506 (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
414 NDA/MAL/H CIRON DRUGS & RENE PHARMACY ADRENALINE ADRENALIN 1MG/ML CIRON DRUGS & INDIA PARENTERAL 1.0X100.0X 7/1/2013 GMP EXPIRED NONE
DP/3938 PHARMACEUTIC LTD INJECTION E PHARMACEUTICALS ORDINARY 1.0 ML ON 2020-05-30
ALS PVT LTD PVT LTD-N-118, N-119 AMPOULES AMPOULE FOR Non-beta
MIDC TARAPUR lactam • SVP
BOISAR DIST THANE injections
401506 (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
415 NDA/MAL/H CIRON DRUGS RENE PHARMACY CICOL DROPS DICYCLOMI 10MG + CIRON DRUGS & INDIA ORAL LIQUID 1.0X10.0 7/1/2014 GMP EXPIRED NONE
DP/4737 AND LTD NE 40MG/ PHARMACEUTICALS ORDINARY ML BOTTLE ON 2020-05-30
PHARMACEUTIC HYDROCHL 5ML PVT LTD-N-118, N-119 DROPS FOR Non-beta
ALS PVT LTD ORIDE + MIDC TARAPUR lactam • SVP
SIMETICONE BOISAR DIST THANE injections
401506 (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
416 NDA/MAL/H AJANTA ABACUS PHARMA BIMAT BIMATOPRO 0.03% W/V CIRON DRUGS & INDIA OPHTHALMI 1.0X1.0X3.0 5/30/2018 GMP EXPIRED NONE
DP/7147 PHARMA (AFRICA) LIMITED ST PHARMACEUTICALS C DROPS ML VIAL ON 2020-05-30
LIMITED PVT LTD-N-118, N-119 FOR Non-beta
MIDC TARAPUR lactam • SVP
BOISAR DIST THANE injections
401506 (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
417 NDA/MAL/H AJANTA ABACUS PHARMA OLOPAT OD OLOPATADI 0.2% W/V CIRON DRUGS & INDIA OPHTHALMI 1.0X1.0X3.0 5/30/2018 GMP EXPIRED NONE
DP/7149 PHARMA (AFRICA) LIMITED NE PHARMACEUTICALS C DROPS ML VIAL ON 2020-05-30
LIMITED HYDROCHL PVT LTD-N-118, N-119 FOR Non-beta
ORIDE MIDC TARAPUR lactam • SVP
BOISAR DIST THANE injections
401506 (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
418 NDA/MAL/H AJANTA ABACUS PHARMA APDROPS DX MOXIFLOXA 5MG+1MG CIRON DRUGS & INDIA OPHTHALMI 1.0X1.0X5.0 5/30/2018 GMP EXPIRED NONE
DP/7151 PHARMA (AFRICA) LIMITED CIN /ML PHARMACEUTICALS C DROPS ML VIAL ON 2020-05-30
LIMITED HYDROCHL PVT LTD-N-118, N-119 FOR Non-beta
ORIDE + MIDC TARAPUR lactam • SVP
DEXAMETH BOISAR DIST THANE injections
ASONE 401506 (Ampoules,
SODIUM MAHARASHTRA INDIA Vials) • SVP
PHOSPHATE (Lyophilized) •
419 NDA/MAL/H AJANTA ABACUS PHARMA LEVOTOP-PF LEVOFLOXA 1.5%W/V CIRON DRUGS & INDIA OPHTHALMI 1.0X1.0X5.0 5/30/2018 GMP EXPIRED NONE
DP/8818 PHARMA LTD (AFRICA) LIMITED CIN PHARMACEUTICALS C DROPS ML VIAL ON 2020-05-30
HEMIHYDRA PVT LTD-N-118, N-119 FOR Non-beta
TE MIDC TARAPUR lactam • SVP
BOISAR DIST THANE injections
401506 (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
420 NDA/MAL/H AJANTA ABACUS PHARMA NEPAFLAM NEPAFENAC 0.1% W/V CIRON DRUGS & INDIA OPHTHALMI 1.0X1.0X5.0 5/30/2018 GMP EXPIRED NONE
DP/8824 PHARMA LTD (AFRICA) LIMITED PHARMACEUTICALS C ML VIAL ON 2020-05-30
PVT LTD-N-118, N-119 SUSPENSION FOR Non-beta
MIDC TARAPUR S lactam • SVP
BOISAR DIST THANE injections
401506 (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
421 NDA/MAL/H CIRON DRUGS & RENE PHARMACY K-ONE PHYTOMEN 10MG/ML CIRON DRUGS & INDIA PARENTERAL 1.0X10.0X1 7/1/2014 GMP EXPIRED NONE
DP/1069 PHARMACEUTIC LTD INJECTION ADIONE PHARMACEUTICALS ORDINARY 0.0X1.0 ML ON 2020-05-30
ALS PVT LTD PVT LTD-N-118, N-119 AMPOULES AMPOULE FOR Non-beta
MIDC TARAPUR lactam • SVP
BOISAR DIST THANE injections
401506 (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
422 NDA/MAL/H CIRON DRUGS ROYAL PHARMA NYSTATIN NYSTATIN 100000 CIRON DRUGS & INDIA ORAL LIQUID 1.0X30.0 1/31/2018 GMP EXPIRED NONE
DP/6999 & 2011 LIMITED ORAL UNITS/5ML PHARMACEUTICALS ORDINARY ML BOTTLE ON 2020-05-30
PHARMACEUTIC SUSPENSION PVT LTD-N-118, N- DRY FOR Non-beta
AL PVT LTD 119, N-113 MIDC SUSPENSION lactam • SVP
TARAPUR BOISAR S/SYRUPS/DR injections
DIST. THANE 401506 OPS (Ampoules,
MAHARASHTRA Vials) • SVP
(Lyophilized) •
423 NDA/MAL/H CIRON DRUGS ROYAL PHARMA CIRAB RABEPRAZO 20 CIRON DRUGS & INDIA PARENTERAL 1.0X20.0 3/28/2019 GMP EXPIRED NONE
DP/7000 & 2011 LIMITED LE SODIUM MG/VIAL PHARMACEUTICALS ORDINARY MG VIAL ON 2020-05-30
PHARMACEUTIC PVT LTD-N-118, N- DRY VIALS FOR Non-beta
AL PVT LTD 119, N-113 MIDC lactam • SVP
TARAPUR BOISAR injections
DIST. THANE 401506 (Ampoules,
MAHARASHTRA Vials) • SVP
(Lyophilized) •
424 NDA/MAL/H CIRON DRUGS & RENE PHARMACY ERGOMETRI ERGOMETRI 0.5MG/ML CIRON DRUGS AND INDIA PARENTERAL 1.0X100.0X 7/1/2007 GMP EXPIRED NONE
DP/3485 PHARMACEUTIC LTD NE NE PHARMACEUTICALS ORDINARY 1.0 ML ON 2020-05-30
ALS PVT LTD MALEATE PRIVATE LTD-N-118 AMPOULES AMPOULE FOR Non-beta
MIDC TARAPUM lactam • SVP
BOISAR DIST THANE injections
401506 (Ampoules,
MAHARASHTRA, Vials) • SVP
INDIA (Lyophilized) •
425 NDA/MAL/H CIRON DRUGS & RENE PHARMACY STERILE QUININE 300MG/ML CIRON DRUGS AND INDIA PARENTERAL 1.0X100.0X 7/1/2007 GMP EXPIRED NONE
DP/3594 PHARMACEUTIC LTD QUININE DIHYDROCH PHARMACEUTICALS ORDINARY 2.0 ML ON 2020-05-30
ALS PVT LTD DIHYDROCHL LORIDE PVT LIMITED-N-118, AMPOULES AMPOULE FOR Non-beta
ORIDE N119, N113, MIDC lactam • SVP
TARAPUR BOISAR DIST injections
THANE 401506, INIDA (Ampoules,
Vials) • SVP
(Lyophilized) •
426 NDA/MAL/H CIRON DRUGS & RENE PHARMACY SUXAMETHO SUXAMETH 50MG/ML CIRON DRUGS AND INDIA PARENTERAL 1.0X10.0X1 7/1/2011 GMP EXPIRED NONE
DP/3680 PHARMACEUTIC LTD NIUM ONIUM PHARMACEUTICALS ORDINARY 0.0X2.0 ML ON 2020-05-30
ALS PVT LTD CHLORIDE CHLORIDE PVT LTD .-N-118, AMPOULES AMPOULE FOR Non-beta
INJECTION N119, N113, MIDC, lactam • SVP
B.P TARAPUR, BOISAR, injections
DIST. THANE 401506, (Ampoules,
INDIA Vials) • SVP
(Lyophilized) •
427 NDA/MAL/H AJANTA ABACUS PHARMA LEVOTOP LEVOFLOXA 0.5%W/V CIRON DRUGS AND INDIA OPHTHALMI 1.0X5.0 ML 3/28/2019 GMP EXPIRED NONE
DP/7145 PHARMA (AFRICA) LIMITED 0.5% CIN PHARMACEUTICALS C DROPS BOTTLE ON 2020-05-30
LIMITED PVT LTD .-N-118, FOR Non-beta
N119, N113, MIDC, lactam • SVP
TARAPUR, BOISAR, injections
DIST. THANE 401506, (Ampoules,
INDIA Vials) • SVP
(Lyophilized) •
428 NDA/MAL/H CIRON DRUGS & RENE PHARMACY CHLORAMPH CHLORAMP 0.5%W/V CIRON DRUGS AND INDIA OPHTHALMI 1.0X1.0X10. 7/1/2007 GMP EXPIRED NONE
DP/3584 PHARMACEUTIC LTD ENICOL EYE HENICOL PHARMACEUTICALS C DROPS 0 ML VIAL ON 2020-05-30
ALS PVT LTD DROPS PVT LTD-N-118 FOR Non-beta
M.I.D.C, lactam • SVP
TAAPUR,BOISAR,DIST. injections
THANE (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
429 NDA/MAL/H CIRON DRUGS RENE PHARMACY CIRATRO ATROPINE 1MG/ML CIRON DRUGS AND INDIA PARENTERAL 1.0X10.0X1 7/1/2008 GMP EXPIRED NONE
DP/4587 AND LTD PHARMACEUTICALS ORDINARY 0.0X1.0 ML ON 2020-05-30
PHARMACEUTIC PVT LTD-N-118 AMPOULES AMPOULE FOR Non-beta
ALS PVT LTD M.I.D.C, lactam • SVP
TAAPUR,BOISAR,DIST. injections
THANE (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
430 NDA/MAL/H CIRON DRUGS & RENE PHARMACY FUROSEMIDE FUROSEMID 10MG/ML CIRON DRUGS AND INDIA PARENTERAL 1.0X10.0X1 7/1/2010 GMP EXPIRED NONE
DP/4979 PHARMACEUTIC LTD E PHARMACEUTICALS ORDINARY 0.0X2.0 ML ON 2020-05-30
ALS PVT LTD PVT LTD-N-118 AMPOULES AMPOULE FOR Non-beta
M.I.D.C, lactam • SVP
TAAPUR,BOISAR,DIST. injections
THANE (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
431 NDA/MAL/H CIRON DRUGS & RENE PHARMACY GENTAMYCI GENTAMYCI 0.3%W/V CIRON DRUGS AND INDIA OPHTHALMI 1.0X10.0 7/1/2009 GMP EXPIRED NONE
DP/5013 PHARMACEUTIC LTD N EYE/EAR N PHARMACEUTICALS C DROPS ML VIAL ON 2020-05-30
ALS PVT LTD DROPS PVT LTD-N-118 FOR Non-beta
M.I.D.C, lactam • SVP
TAAPUR,BOISAR,DIST. injections
THANE (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
432 NDA/MAL/H CIRON DRUGS RENE PHARMACY CHLORAMPH CHLORAMP 1G CIRON DRUGS AND INDIA PARENTERAL 1.0X25.0X1. 7/1/2007 GMP EXPIRED NONE
DP/8208 & LTD ENICOL HENICOL PHARMACEUTICALS ORDINARY 0 G VIAL ON 2020-05-30
PHARMACEUTIC SODIUM SODIUM PVT LTD-N-118 DRY VIALS FOR Non-beta
AL PVT LTD SUCCINATE SUCCINATE M.I.D.C, lactam • SVP
TAAPUR,BOISAR,DIST. injections
THANE (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
433 NDA/MAL/H CIRON DRUGS & RENE PHARMACY TOOCHE MULTI- MULTI- CIRON DRUGS AND INDIA ORAL 1.0X10.0 7/1/2014 GMP EXPIRED NONE
HP/5597 PHARMACEUTIC LTD DROPS INGREDIENT INGREDIEN PHARMACEUTICALS TOPICAL ML BOTTLE ON 2020-05-30
ALS PVT LTD T PVT LTD-N-118 DROPS FOR Non-beta
M.I.D.C, lactam • SVP
TAAPUR,BOISAR,DIST. injections
THANE (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
434 NDA/MAL/H CIRON DRUGS & RENE PHARMACY CHLORAMPH CHLORAMP 5%W/V CIRON DRUGS AND INDIA OTIC DROPS 1.0X10.0 7/1/2007 GMP EXPIRED NONE
DP/1432 PHARMACEUTIC LTD ENICOL EAR HENICOL PHARMACEUTICALS ML VIAL ON 2020-05-30
ALS PVT LTD DROPS PVT LTD-N-118 FOR Non-beta
M.I.D.C, lactam • SVP
TAAPUR,BOISAR,DIST. injections
THANE (Ampoules,
MAHARASHTRA INDIA Vials) • SVP
(Lyophilized) •
435 NDA/MAL/H CIRON DRUGS & RENE PHARMACY LUTHER ARTEMETHE 80MG/ML CIRON DRUGS AND INDIA PARENTERAL 1.0X6.0X1.0 7/1/2016 GMP EXPIRED NONE
DP/6246 PHARMACEUTIC LTD R PHARMACEUTICALS ORDINARY I ML ON 2020-05-30
ALS PVT LTD PVT. LTD-N-118, M AMPOULE FOR Non-beta
N119, N113, MIDC, AMPOULES lactam • SVP
TARAPUR, BOISAR, injections
DIST. THANE 401506, (Ampoules,
INDIA Vials) • SVP
(Lyophilized) •
436 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA ELYCLOX AMPICILLIN 125MG/12 ELYS CHEMICAL KENYA ORAL LIQUID 1.0X100.0 7/1/2015 GMP EXPIRED NONE
DP/1017 INDUSTRIES LTD LIMITED /CLOXACILLI 5MG INDUSTRIES LIMITED- ORDINARY ML BOTTLE ON 2020-05-31
N ROAD B’, OFF DRY FOR 1. Tablets,
ENTERPRISE ROAD SUSPENSION coated and
PLOT NO. 209/8927 S/SYRUPS/DR uncoated 2. Oral
INDUSTRIAL AREA OPS liquids 3. Oral
Rehydration
Salts 4. Hard
437 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA ELYZOLE ALBENDAZO 200MG ELYS CHEMICAL KENYA ORAL SOLID 1.0X20.0X2. 7/1/2005 GMP EXPIRED NONE
DP/1537 INDUSTRIES LTD LIMITED LE INDUSTRIES LIMITED- ORDINARY 0 TABLET ON 2020-05-31
ROAD B’, OFF TABLETS BLISTER FOR 1. Tablets,
ENTERPRISE ROAD coated and
PLOT NO. 209/8927 uncoated 2. Oral
INDUSTRIAL AREA liquids 3. Oral
Rehydration
Salts 4. Hard
438 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA ELYZOLE ALBENDAZO 200MG ELYS CHEMICAL KENYA ORAL LIQUID 1.0X10.0 7/1/2003 GMP EXPIRED NONE
DP/1538 INDUSTRIES LTD LIMITED SUSPENSION LE INDUSTRIES LIMITED- ORDINARY ML BOTTLE ON 2020-05-31
ROAD B’, OFF SUSPENSION FOR 1. Tablets,
ENTERPRISE ROAD S coated and
PLOT NO. 209/8927 uncoated 2. Oral
INDUSTRIAL AREA liquids 3. Oral
Rehydration
Salts 4. Hard
439 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA CANDISTAT CLOTRIMAZ 1%W/W ELYS CHEMICAL KENYA ORAL 1.0X20.0 G 7/1/2001 GMP EXPIRED NONE
DP/1932 INDUSTRIES LTD LIMITED CREAM OLE INDUSTRIES LIMITED- TOPICAL TUBE ON 2020-05-31
ROAD B’, OFF CREAMS FOR 1. Tablets,
ENTERPRISE ROAD coated and
PLOT NO. 209/8927 uncoated 2. Oral
INDUSTRIAL AREA liquids 3. Oral
Rehydration
Salts 4. Hard
440 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA ALUGEL ALUMINIUM 120MG/25 ELYS CHEMICAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997 GMP EXPIRED NONE
DP/3390 INDUSTRIES LTD LIMITED HYDROXIDE 0MG INDUSTRIES LTD- ORDINARY ML ON 2020-05-31
L/ ROAD 'B' OFF SUSPENSION BOTTLE,1.0 FOR 1. Tablets,
MAGNESIU ENTERPRISE ROAD, S X5.0 ML coated and
M INDUSTRIAL AREA JERRYCAN uncoated 2. Oral
TRISLICATE NAIROBI liquids 3. Oral
Rehydration
Salts 4. Hard
441 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA AMPILIN AMPICILLIN 250MG ELYS CHEMICAL KENYA ORAL SOLID 1.0X10.0X1 7/1/1997 GMP EXPIRED NONE
DP/3585 INDUSTRIES LTD LIMITED INDUSTRIES LTD- ORDINARY 0.0 ON 2020-05-31
ROAD 'B' OFF CAPSULES CAPSULE FOR 1. Tablets,
ENTERPRISE ROAD, BLISTER,1.0 coated and
INDUSTRIAL AREA X1000.0 uncoated 2. Oral
NAIROBI CAPSULE liquids 3. Oral
CONTAINER Rehydration
Salts 4. Hard
442 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA VUMTREX LEVAMISOL 40MG/5ML ELYS CHEMICAL KENYA ORAL LIQUID 1.0X30.0 7/1/2003 GMP EXPIRED NONE
DP/3603 INDUSTRIES LTD LIMITED SYRUP E INDUSTRIES LTD- ORDINARY ML BOTTLE ON 2020-05-31
ROAD 'B' OFF SYRUPS FOR 1. Tablets,
ENTERPRISE ROAD, coated and
INDUSTRIAL AREA uncoated 2. Oral
NAIROBI liquids 3. Oral
Rehydration
Salts 4. Hard
443 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA AMPILIN AMPICILLIN 125MG/5M ELYS CHEMICAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997 GMP EXPIRED NONE
DP/3621 INDUSTRIES LTD LIMITED L INDUSTRIES LTD- ORDINARY ML BOTTLE ON 2020-05-31
ROAD 'B' OFF DRY FOR 1. Tablets,
ENTERPRISE ROAD, SUSPENSION coated and
INDUSTRIAL AREA S/SYRUPS/DR uncoated 2. Oral
NAIROBI OPS liquids 3. Oral
Rehydration
Salts 4. Hard
444 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA BUKOL HYOSCINE N- 10MG ELYS CHEMICAL KENYA ORAL SOLID 1.0X10.0X1 7/1/1997 GMP EXPIRED NONE
DP/3766 INDUSTRIES LTD LIMITED TABLETS BUTYLBRO INDUSTRIES LTD- ORDINARY 0.0 TABLET ON 2020-05-31
MIDE ROAD 'B' OFF OTHER BLISTER,1.0 FOR 1. Tablets,
ENTERPRISE ROAD, COATED X1000.0 coated and
INDUSTRIAL AREA TABLETS TABLET uncoated 2. Oral
NAIROBI CONTAINER liquids 3. Oral
Rehydration
Salts 4. Hard
445 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA FUNGISTIN NYSTATIN 100000 ELYS CHEMICAL INDIA ORAL LIQUID 1.0X30.0 7/1/2002 GMP EXPIRED NONE
DP/3801 INDUSTRIES LTD LIMITED ORAL IU/ML INDUSTRIES LTD- ORDINARY ML BOTTLE ON 2020-05-31
SUSPENSION ROAD 'B' OFF SUSPENSION FOR 1. Tablets,
ENTERPRISE ROAD, S coated and
INDUSTRIAL AREA uncoated 2. Oral
NAIROBI liquids 3. Oral
Rehydration
Salts 4. Hard
446 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA MIFUPEN ACETYLSALI 350 MG + ELYS CHEMICAL KENYA ORAL SOLID 1.0X100.0 7/1/1997 GMP EXPIRED NONE
DP/3926 INDUSTRIES LTD LIMITED TABLETS CYLIC ACID 50 MG INDUSTRIES LTD- ORDINARY TABLET ON 2020-05-31
+ CAFFEINE ROAD 'B' OFF TABLETS STRIP FOR 1. Tablets,
ENTERPRISE ROAD, coated and
INDUSTRIAL AREA uncoated 2. Oral
NAIROBI liquids 3. Oral
Rehydration
Salts 4. Hard
447 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA ELYCORT HYDROCOR 1%W/W ELYS CHEMICAL KENYA TOPICAL 1.0X15.0 G 7/1/1997 GMP EXPIRED NONE
DP/4609 INDUSTRIES LTD LIMITED TISONE INDUSTRIES LTD- EXTERNAL TUBE ON 2020-05-31
ROAD 'B' OFF CREAMS FOR 1. Tablets,
ENTERPRISE ROAD, coated and
INDUSTRIAL AREA uncoated 2. Oral
NAIROBI liquids 3. Oral
Rehydration
Salts 4. Hard
448 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA ELYPEN PHENOXYM 250MG ELYS CHEMICAL KENYA ORAL SOLID 1.0X10.0X1 7/1/1997 GMP EXPIRED NONE
DP/4690 INDUSTRIES LTD LIMITED ETHYL INDUSTRIES LTD- ORDINARY 0.0 TABLET ON 2020-05-31
PENICILLIN ROAD 'B' OFF TABLETS BLISTER,1.0 FOR 1. Tablets,
ENTERPRISE ROAD, X1000.0 coated and
INDUSTRIAL AREA TABLET uncoated 2. Oral
NAIROBI CONTAINER liquids 3. Oral
Rehydration
Salts 4. Hard
449 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA ELYVATE BETAMETHA 1%W/W ELYS CHEMICAL KENYA TOPICAL 1.0X15.0 G 7/1/1997 GMP EXPIRED NONE
DP/4693 INDUSTRIES LTD LIMITED SONE INDUSTRIES LTD- EXTERNAL TUBE ON 2020-05-31
VALERATE ROAD 'B' OFF OINTMENTS FOR 1. Tablets,
ENTERPRISE ROAD, coated and
INDUSTRIAL AREA uncoated 2. Oral
NAIROBI liquids 3. Oral
Rehydration
Salts 4. Hard
450 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA ELYVATE BETAMETHA 0.1%W/W ELYS CHEMICAL KENYA TOPICAL 1.0X15.0 G 7/1/1997 GMP EXPIRED NONE
DP/0033 INDUSTRIES LTD LIMITED CREAM SONE INDUSTRIES LTD- EXTERNAL TUBE ON 2020-05-31
VALERATE ROAD 'B' OFF CREAMS FOR 1. Tablets,
ENTERPRISE ROAD, coated and
INDUSTRIAL AREA uncoated 2. Oral
NAIROBI liquids 3. Oral
Rehydration
Salts 4. Hard
451 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA WHITFIELD'S BENZOIC 6%W/W + ELYS CHEMICAL KENYA TOPICAL 1.0X20.0 G 7/1/2003 GMP EXPIRED NONE
DP/0698 INDUSTRIES LTD LIMITED OINTMENT ACID+SALIC 3%W/W INDUSTRIES LTD- EXTERNAL TUBE ON 2020-05-31
YLIC CID ROAD 'B' OFF OINTMENTS FOR 1. Tablets,
ENTERPRISE ROAD, coated and
INDUSTRIAL AREA uncoated 2. Oral
NAIROBI liquids 3. Oral
Rehydration
Salts 4. Hard
452 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA ELYMOL PARACETAM 120MG/5M ELYS CHEMICAL KENYA ORAL LIQUID 1.0X60.0 7/1/1997 GMP EXPIRED NONE
DP/2122 INDUSTRIES LTD LIMITED OL L INDUSTRIES LTD- ORDINARY ML ON 2020-05-31
ROAD 'B' OFF SUSPENSION BOTTLE,1.0 FOR 1. Tablets,
ENTERPRISE ROAD, S X100.0 ML coated and
INDUSTRIAL AREA BOTTLE uncoated 2. Oral
NAIROBI liquids 3. Oral
Rehydration
Salts 4. Hard
453 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA ELYMOX AMOXYCILLI 125MG/5M ELYS CHEMICAL KENYA ORAL LIQUID 1.0X100.0 7/1/1997 GMP EXPIRED NONE
DP/2124 INDUSTRIES LTD LIMITED N L INDUSTRIES LTD- ORDINARY ML BOTTLE ON 2020-05-31
ROAD 'B' OFF DRY FOR 1. Tablets,
ENTERPRISE ROAD, SUSPENSION coated and
INDUSTRIAL AREA S/SYRUPS/DR uncoated 2. Oral
NAIROBI OPS liquids 3. Oral
Rehydration
Salts 4. Hard
454 NDA/MAL/H ELYS CHEMICAL VELVET PHARMA ELYCORT HYDROCOR 1%W/W ELYS CHEMICAL KENYA TOPICAL 1.0X15.0 G 7/1/1997 GMP EXPIRED NONE
DP/2164 INDUSTRIES LTD LIMITED TISONE INDUSTRIES LTD- EXTERNAL TUBE ON 2020-05-31
ROAD 'B' OFF OINTMENTS FOR 1. Tablets,
ENTERPRISE ROAD, coated and
INDUSTRIAL AREA uncoated 2. Oral
NAIROBI liquids 3. Oral
Rehydration
Salts 4. Hard
455 NDA/MAL/V FATRO S.P.A GLOBAL VET (U) BIO–VAC HITCHNER HITCHNER FATRO S.P.A-FATRO ITALY ORAL LIQUID 1.0X1000.0 11/29/2017 GMP EXPIRED NONE
DP/8364 LIMITED ND–IB B1 STRAIN + B1 STRAIN - S.P.A VIA MOLINO ORDINARY DOSE VIAL ON 2020-05-16
MASSACHU ≥10⁶·⁵ EMILI, 225030 SOLUBLE
SETTS H-120 EID₅₀/DOSE MACLODIO (BS) ITALY POWDERS Volume
+ Parenterals -
MASSACHU Solutions and
SETTS H- Lyophilised
120 - powders (Live
456 NDA/MAL/V THE PAN GLOBAL VET (U) VAIOL-VAC LIVE ≥10⁴EID₅₀/ FATRO S.P.A-VIA ITALY ORAL LIQUID 1.0X10.0X1 1/31/2018 GMP EXPIRED NONE
DP/8360 AFRICAN LIMITED ATTENUATE DOSE MOLINO EMILI 2, ORDINARY 000.0 DOSE ON 2020-05-16
VETERINARY D AVIAN MACLODIO (BS, ITALY) DROPS VIAL
VACCINE FOWLPOX Volume
CENTRE OF VIRUS, HP-2 Parenterals -
AFRICAN UNION STRAIN-2 Solutions and
(AU/PANVAC) Lyophilised
powders (Live
457 NDA/MAL/V FATRO S.P.A GLOBAL VET (U) S.E.T-VAC INACTIVATE 1,000,000, FATRO S.P.A-VIA ITALY PARENTERAL 1.0X500.0 1/31/2018 GMP EXPIRED NONE
DP/8362 LIMITED D CULTURE 000CFU/D MOLINO EMILI 2, ORDINARY DOSE VIAL ON 2020-05-16
OF OSE + MACLODIO (BS, ITALY) VIALS (250ML),1.0
SALMONELL 1,000,000, X1000.0 Volume
A 000CFU/D DOSE VIAL Parenterals -
ENTERITIDIS OSE (500ML) Solutions and
+ Lyophilised
INACTIVATE powders (Live
458 NDA/MAL/V FATRO S.P.A GLOBAL VET (U) IBA-VAC LIVE ≥10³EID₅₀/ FATRO S.P.A-VIA ITALY ORAL LIQUID 1.0X1000.0 1/31/2018 GMP EXPIRED NONE
DP/8368 LIMITED ATTENUATE DOSE MOLINO EMILI 2, ORDINARY DOSE ON 2020-05-16
D VIRUS OR MACLODIO (BS, ITALY) SUSPENSION VIAL,1.0X25
GUMBORO S 00.0 DOSE Volume
DISEASE, VIAL,1.0X50 Parenterals -
1/65PV 00.0 DOSE Solutions and
STRAIN VIAL,1.0X10 Lyophilised
.0X1000.0 powders (Live
459 NDA/MAL/V FATRO S.P.A GLOBAL VET (U) BI-VAC 1º AVIAN ≥10⁴EID₅₀/ FATRO S.P.A-VIA ITALY ORAL LIQUID 1.0X10.0X1 1/31/2018 GMP EXPIRED NONE
DP/8370 LIMITED INFECTIOUS DOSE MOLINO EMILI 2, ORDINARY 000.0 DOSE ON 2020-05-16
BRONCHITIS MACLODIO (BS, ITALY) DRY VIAL,1.0X10
VIRUS, SUSPENSION .0X2500.0 Volume
MASSACHU S/SYRUPS/DR DOSE Parenterals -
SETTS H120 OPS VIAL,1.0X10 Solutions and
STRAIN .0X5000.0 Lyophilised
VACCINE(FR DOSE VIAL powders (Live
460 NDA/MAL/V FATRO S.P.A GLOBAL VET (U) BIO-VAC LA NEWCASTLE 10^6.5 FATRO S.P.A-VIA ITALY ORAL LIQUID1.0X1.0X10 1/31/2018 GMP EXPIRED NONE
DP/8371 LIMITED SOTA DISEASE EID50/DOS MOLINO EMILI 2, ORDINARY 00.0 DOSE ON 2020-05-16
VIRUS E MACLODIO (BS, ITALY) DRY VIAL,1.0X1.
(STRAIN LA SUSPENSION 0X2500.0 Volume
SOTA) S/SYRUPS/DRDOSE Parenterals -
OPS VIAL,1.0X1. Solutions and
0X500.0 Lyophilised
DOSE powders (Live
461 NDA/MAL/V FATRO S.P.A GLOBAL VET (U) BIO-MAREK FREEZE 1500 FATRO S.P.A-VIA ITALY PARENTERAL 1.0X1000.0 1/31/2018 GMP EXPIRED NONE
DP/8372 LIMITED HVT DRIED FC PLAQUE MOLINO EMILI 2, ORDINARY DOSE ON 2020-05-16
126 STRAIN FORMING MACLODIO (BS, ITALY) DRY VIALS VIAL,1.0X20
OF HERPES UNITS/ 00.0 DOSE Volume
VIRUS OF DOSE VIAL Parenterals -
TURKEY Solutions and
(HVT) Lyophilised
powders (Live
462 NDA/MAL/V FATRO S.P.A GLOBAL VET (U) BI-VAC 2º ATTENUATE ≥10⁴EID₅₀/ FATRO S.P.A-VIA ITALY ORAL LIQUID 1.0X10.0X1 1/31/2018 GMP EXPIRED NONE
DP/8387 LIMITED D AVIAN DOSE MOLINO EMILI 2, ORDINARY 000.0 DOSE ON 2020-05-16
INFECTIOUS MACLODIO (BS, ITALY) DRY VIAL,1.0X10
BRONCHITIS SUSPENSION .0X2500.0 Volume
VIRUS, S/SYRUPS/DR DOSE Parenterals -
MASSACHU OPS VIAL,1.0X10 Solutions and
SETTS H-52 .0X5000.0 Lyophilised
STRAIN DOSE VIAL powders (Live
463 NDA/MAL/V HEBEI HOPE JUBAILI AGROTEC ALBENOR ALBENDAZO 2500MG HEBEI HARMONY CHINA ORAL SOLID 1.0X20.0 7/1/2017 GMP EXPIRE ON NONE
DP/8256 HARMONY LIMITED 2500 LE PHARMACEUTICAL ORDINARY BOLUS 2020 -05-30 FOR
PHARMACEUTIC CO. LTD- INDUSTRIAL OTHER BLISTER - Tablets - Oral
AL CO., LTD ZOO YUANSHI TOWN TABLETS solutions -
SHIJIAZHUANG CITY Soluble powders -
HEBEI PROVINCE SVP solutions in
ampoules and
vials.
464 NDA/MAL/V HEBEI HOPE JUBAILI AGROTEC TETRANOR OXYTETRAC 10%W/V HEBEI HARMONY CHINA PARENTERAL 1.0X250.0 7/1/2017 GMP EXPIRE ON NONE
DP/8260 HARMONY LIMITED 10 YCLINE PHARMACEUTICAL ORDINARY ML 2020 -05-30 FOR
PHARMACEUTIC HYDROCHL CO. LTD- INDUSTRIAL VIALS VIAL,1.0X50 - Tablets - Oral
AL CO., LTD ORIDE ZOO YUANSHI TOWN 0.0 ML solutions -
SHIJIAZHUANG CITY VIAL,1.0X10 Soluble powders -
HEBEI PROVINCE 0.0 ML VIAL SVP solutions in
ampoules and
vials.
465 NDA/MAL/V HEBEI HOPE JUBAILI AGROTEC ALBENOR ALBENDAZO 2.5%W/V HEBEI HARMONY CHINA ORAL LIQUID1.0X500.0 7/1/2017 GMP EXPIRE ON NONE
DP/8269 HARMONY LIMITED 2.5% LE PHARMACEUTICAL ORDINARY ML 2020 -05-30 FOR
PHARMACEUTIC CO. LTD- INDUSTRIAL SUSPENSION CONTAINER - Tablets - Oral
AL CO., LTD ZOO YUANSHI TOWN S ,1.0X1000.0 solutions -
SHIJIAZHUANG CITY ML Soluble powders -
HEBEI PROVINCE CONTAINER SVP solutions in
,1.0X100.0 ampoules and
ML vials.
466 NDA/MAL/V HEBEI HOPE JUBAILI AGROTEC TETRANOR OXYTETRAC 20%W/V HEBEI HARMONY CHINA PARENTERAL 1.0X250.0 7/1/2017 GMP EXPIRE ON NONE
DP/8270 HARMONY LIMITED 20 L.A YCLINE PHARMACEUTICAL ORDINARY ML 2020 -05-30 FOR
PHARMACEUTIC DIHYDRATE CO. LTD- INDUSTRIAL VIALS VIAL,1.0X10 - Tablets - Oral
AL CO., LTD ZOO YUANSHI TOWN 0.0 ML solutions -
SHIJIAZHUANG CITY VIAL,1.0X50 Soluble powders -
HEBEI PROVINCE 0.0 ML VIAL SVP solutions in
ampoules and
vials.
467 NDA/MAL/V HEBEI HOPE JUBAILI AGROTEC TETRANOR OXYTETRAC 30%W/V HEBEI HARMONY CHINA PARENTERAL 1.0X100.0 7/1/2017 GMP EXPIRE ON NONE
DP/8271 HARMONY LIMITED 30 L.A YCLINE PHARMACEUTICAL ORDINARY ML 2020 -05-30 FOR
PHARMACEUTIC HYDROCHL CO. LTD- INDUSTRIAL VIALS VIAL,1.0X25 - Tablets - Oral
AL CO., LTD ORIDE ZOO YUANSHI TOWN 0.0 ML VIAL solutions -
SHIJIAZHUANG CITY Soluble powders -
HEBEI PROVINCE SVP solutions in
ampoules and
vials.
468 NDA/MAL/H MERCK SHARP & PHILLIPS STOCRIN EFAVIRENZ 600MG MERCK SHARP & CHINA ORAL SOLID 1.0X30.0 7/1/2004 GMP EXPIRED ZHEJIANG
DP/2394 DOHME BV PHARMACEUTICA DOHME B.V- ORDINARY TABLET ON 2020-04-25 HUAHAI
LS (UGANDA) WAARDENWEG TABLETS BOTTLE FOR Hard PHARMACEUTIC
LIMITED 392031 BN, HAARLEM Gelatin Capsules AL CO. LTD-
Oral liquids XUNQIAO,
Powders for oral LINHAI,
suspension Oral ZHEJIANG
granules PROVINCE
469 NDA/MAL/V MELO MELO HANEGG- OXYTETRAC 10 G + PHARMACEUTICAL VIETNAM ORAL LIQUID 1.0X1.0 KG 1/31/2018 GMP EXPIRED NONE
DP/8478 PHARMACEUTIC PHARMACEUTICA PLUS YCLINE 4MG + 750 AND VETERINARY ORDINARY SACHET ON 2020-05-09
ALS LIMITED LS LIMITED HCL+NEOM 000 IU + MATERIAL JSC SOLUBLE FOR - SVP
YCIN (AS 150 000 IU (HANVET)-PHO NOI A POWDERS solutions. - Oral
SULFATE)+VI + 250 MG INDUSTRIAL ZONE powders. - Oral
TAMIN + 100MG + HUNG,YEN PROVINCE, liquids. - Topical
A+VITAMIN 200MG + VIETNAM solutions
D3+VITAMI 200MG +
470 NDA/MAL/V MELO MELO TYLOSIN-200 TYLOSIN 200 PHARMACEUTICAL VIETNAM PARENTERAL 1.0X100.0 5/30/2018 GMP EXPIRED NONE
DP/8700 PHARMACEUTIC PHARMACEUTICA TARTRATE MG/ML AND VETERINARY ORDINARY ML VIAL ON 2020-05-09
ALS LIMITED LS LIMITED MATERIAL JSC VIALS FOR - SVP
(HANVET)-PHO NOI A solutions. - Oral
INDUSTRIAL ZONE powders. - Oral
HUNG,YEN PROVINCE, liquids. - Topical
VIETNAM solutions
471 NDA/MAL/H PFIZER LABOREX CYTOTEC MISOPROST 200MCG PIRAMAL UNITED ORAL SOLID 1.0X2.0X14. 7/1/2010 GMP EXPIRED NONE
DP/2756 LABORATORIES UGANDA OL HEALTHCARE LIMITED- KINGDOM ORDINARY 0 TABLET ON 2020-04-05
LTD LIMITED WALTON ROAD FILM- BLISTER FOR Tablets HGC
MORPETH COATED
NORTHUMBERLAND TABLETS
NE 613YA

472 NDA/MAL/H NORVATIS LABOREX VIGAMOX MOXIFLOXA 5MG/ML S.A.ALCON COUVREUR BELGIUM OPHTHALMI 1.0X5.0 ML 7/1/2013 GMP EXPIRED NONE
DP/1636 PHARMA AG- UGANDA CIN N.V-RIJKSWEG 14, B- C DROPS BOTTLE ON 2020-04-03
SWITZERLAND LIMITED 2870 PUURS BELGIUM FOR Aseptically
prepared semi
solids
(Ointments) Eye
drops
473 NDA/MAL/H SEARLE HEALTHCARE METODINE- METRONIDA 200MG/25 SEARLE PAKISTAN PAKISTAN ORAL LIQUID 1.0X60.0 7/1/2004 GMP EXPIRED NONE
DP/3299 PAKISTAN LTD. DF ZOLE/DILOX 0MG LIMITED-PLOT 35KM, ORDINARY ML BOTTLE ON 2020-05-12
LIMITED SUSPENSION ANIDE MULTAN ROAD, SUSPENSION FOR Non Beta-
FUROATE LAHORE - PAKISTAN S lactam Tablets
(Coated and
Uncoated) Hard
Gelatin Capsules
Oral liquids
474 NDA/MAL/H GUILIN PHILLIPS AMOXICILLIN AMOXICILLI 250MG SINOPHARM WEIQIDA CHINA ORAL SOLID 1.0X1000.0 1/31/2018 GMP EXPIRED NONE
DP/6300 PHARMACEUTIC PHARMACEUTICA N PHARMACEUTICAL ORDINARY CAPSULE ON 2020-05-23
AL (SHANGHAI) LS (UGANDA) CO., LTD-OSD CAPSULES CONTAINER
CO., LTD LIMITED WORKSHOP OF ,1.0X2.0X10 (coated and
ECONOMIC & .0 CAPSULE
TECHNOLOGICAL BLISTER Hard gelatin
DEVELOPMENT ZONE,
SECOND MEDICAL powders
475 NDA/MAL/H GUILIN STAR GAMOK AMOXICILLI 500MG + SINOPHARM WEIQIDA CHINA ORAL SOLID 1.0X1.0X10. 7/25/2018 GMP EXPIRED NONE
DP/8944 PHARMACEUTIC PHARMACEUTICA 625MG N 125MG PHARMACEUTICAL ORDINARY 0 TABLET ON 2020-05-23
ALS CO.LTD. LS LTD TRIHYDRATE CO., LTD-OSD FILM- BLISTER
+ WORKSHOP OF COATED (coated and
CLAVULANA ECONOMIC & TABLETS
TE TECHNOLOGICAL Hard gelatin
POTASSIUM DEVELOPMENT ZONE,
SECOND MEDICAL powders
476 NDA/MAL/H GUILIN STAR GAMOK 0.6G AMOXICILLI 500MG + SINOPHARM WEIQIDA CHINA PARENTERAL 1.0X10.0X0. 7/25/2018 GMP EXPIRED NONE
DP/8946 PHARMACEUTIC PHARMACEUTICA N SODIUM + 100MG PHARMACEUTICAL ORDINARY 6 G VIAL ON 2020-05-23
ALS CO.LTD. LS LTD CLAVULANA CO., LTD-OSD DRY VIALS
TE WORKSHOP OF (coated and
POTASSIUM ECONOMIC &
TECHNOLOGICAL Hard gelatin
DEVELOPMENT ZONE,
SECOND MEDICAL powders
477 NDA/MAL/H GUILIN STAR GAMOK 1.2G AMOXICILLI 1G + 0.2G SINOPHARM WEIQIDA CHINA PARENTERAL 1.0X10.0X1. 7/25/2018 GMP EXPIRED NONE
DP/8947 PHARMACEUTIC PHARMACEUTICA N SODIUM + PHARMACEUTICAL ORDINARY 2 G VIAL ON 2020-05-23
ALS CO.LTD. LS LTD CLAVULANA CO., LTD-OSD DRY VIALS
TE WORKSHOP OF (coated and
POTASSIUM ECONOMIC &
TECHNOLOGICAL Hard gelatin
DEVELOPMENT ZONE,
SECOND MEDICAL powders
478 NDA/MAL/H SEARLE HEALTHCARE HYDRYLLIN DIPHENHYD 5MG/6.25 THE SEARLE PAKISTAN ORAL LIQUID 1.0X120.0 7/1/1997 GMP EXPIRED NONE
DP/5340 PAKISTAN LTD. SYRUP RAMINE MG COMPANY-32-KM ORDINARY ML BOTTLE ON 2020-05-12
LIMITED HCL/DEXTR MULTAN ROAD, SYRUPS FOR Non Beta-
OMETHORP LAHORE lactam Tablets
HAN HBR (Coated and
Uncoated) Hard
Gelatin Capsules
Oral liquids
479 NDA/MAL/H SEARLE HEALTHCARE HYDRYLLIN AMINOPHYL 32MG THE SEARLE PAKISTAN ORAL LIQUID 1.0X120.0 7/1/1997 GMP EXPIRED NONE
DP/6714 PAKISTAN LTD. SYRUP LINE+ +300MG+8 COMPANY-32-KM ORDINARY ML BOTTLE ON 2020-05-12
LIMITED AMMONIU MG MULTAN ROAD, SYRUPS FOR Non Beta-
M HCL+ LAHORE lactam Tablets
DIPHENHYD (Coated and
RAMINE Uncoated) Hard
HCL Gelatin Capsules
Oral liquids
480 NDA/MAL/H SEARLE HEALTHCARE PEDITRAL ORAL N/A THE SEARLE PAKISTAN ORAL LIQUID 1.0X29.5 G 7/1/1997 GMP EXPIRED NONE
DP/3226 PAKISTAN LTD. REHYDRATI COMPANY-32-KM ORDINARY SACHET ON 2020-05-12
LIMITED ON SALT MULTAN ROAD, SOLUBLE FOR Non Beta-
LAHORE POWDERS lactam Tablets
(Coated and
Uncoated) Hard
Gelatin Capsules
Oral liquids
481 NDA/MAL/H SEARLE HEALTHCARE SPIROMIDE SPIRONOLA 50MG+20 THE SEARLE INDIA ORAL SOLID 1.0X2.0X10. 7/1/2005 GMP EXPIRED NONE
DP/1577 PAKISTAN LTD LTD. CTONE + MG COMPANY-32-KM ORDINARY 0 TABLET ON 2020-05-12
FRUSEMIDE MULTAN ROAD, TABLETS STRIP FOR Non Beta-
LAHORE lactam Tablets
(Coated and
Uncoated) Hard
Gelatin Capsules
Oral liquids
482 NDA/MAL/H SANOFI AVENTS SURGIPHARM (U) RHINATHIOL CARBOCISTE 20MG/ML UNITHER LIQUID FRANCE ORAL LIQUID 1.0X125.0 7/1/2001 GMP EXPIRED A.
DP/4550 FRANCE LIMITED 2% INE MANUFACTURING ORDINARY ML BOTTLE ON 2020-05-31 NATTERMANN &
INDUSTRIE - SYRUPS FOR Coated and CIE GMBH.-
COLOMIERS 1-3 ALLE uncoated tablets NATTERMANNA
DE LA NESTE L DEN Hard gelatin LLEE 1 ,50829
SIGAL 31770 capsules COLOGNE,
Powders for oral GERMANY
suspension
483 NDA/MAL/H SANOFI AVENTS SURGIPHARM (U) EPILIM SODIUM 200MG/5M UNITHER LIQUID FRANCE ORAL LIQUID 1.0X200.0 7/1/1998 GMP EXPIRED NONE
DP/4127 FRANCE LIMITED VALPROATE L MANUFACTURING ORDINARY ML ON 2020-05-31
INDUSTRIE - SYRUPS BOTTLE,1.0 FOR Coated and
COLOMIERS 1-3 ALLE X300.0 ML uncoated tablets
DE LA NESTE L DEN BOTTLE Hard gelatin
SIGAL 31770 capsules
Powders for oral
suspension
484 NDA/MAL/H VOGEN BUFFALO HEALTH DURAMOX AMOXICILLI 250MG/5M VOGEN CYPRUS ORAL LIQUID 1.0X100.0 7/1/2007 GMP EXPIRED NONE
DP/1034 LABORATORIES CARE LTD N L LABORATORIES LTD- ORDINARY ML BOTTLE ON 2020-04-03
LTD 70, M.HERACLEOUS DRY FOR Powders for
STR. AYIOS SUSPENSION oral suspension
ATHANASIOS S/SYRUPS/DR Hard Gelatin
INDUSTRIAL AREA, OPS Capsules
LIMASSOL, CYPRUS
485 NDA/MAL/H VOGEN BUFFALO HEALTH DURAMOX AMOXICILLI 125MG/5M VOGEN CYPRUS ORAL LIQUID 1.0X100.0 7/1/2007 GMP EXPIRED NONE
DP/1469 LABORATORIES CARE LTD 125 N L LABORATORIES LTD- ORDINARY ML BOTTLE ON 2020-04-03
LTD 70, M.HERACLEOUS DRY FOR Powders for
STR. AYIOS SUSPENSION oral suspension
ATHANASIOS S/SYRUPS/DR Hard Gelatin
INDUSTRIAL AREA, OPS Capsules
LIMASSOL, CYPRUS
486 NDA/MAL/H VOGEN BUFFALO HEALTH DURAMOX AMOXICILLI 500MG VOGEN CYPRUS ORAL SOLID 1.0X2.0X10. 7/1/2007 GMP EXPIRED NONE
DP/2224 LABORATORIES CARE LTD 500 N LABORATORIES LTD- ORDINARY 0 CAPSULE ON 2020-04-03
LTD 70, M.HERACLEOUS CAPSULES BLISTER,1.0 FOR Powders for
STR. AYIOS X10.0X10.0 oral suspension
ATHANASIOS CAPSULE Hard Gelatin
INDUSTRIAL AREA, BLISTER Capsules
LIMASSOL, CYPRUS
487 NDA/MAL/H WILSHIRE HEALTHCARE ZEECIN AZITHROMY 250MG WILSHIRE PAKISTAN ORAL SOLID 1.0X2.0X3.0 5/29/2019 GMP EXPIRED NONE
DP/6957 LABORATORIES LTD. CIN LABORATORIES (PVT) ORDINARY TABLET ON 2020-05-05
(PVT) LTD DIHYDRATE LTD-124/1 TABLETS BLISTER FOR Coated and
INDUSTRIAL AREA, uncoated tablets
KOT LAKHPAT Hard gelatin
LAHORE PAKISTAN capsules
Powders for oral
suspension
488 NDA/MAL/H WILSHIRE HEALTHCARE ZEECIN AZITHROMY 500MG WILSHIRE PAKISTAN ORAL SOLID 1.0X1.0X3.0 5/29/2019 GMP EXPIRED NONE
DP/6958 LABORATORIES LTD. CIN LABORATORIES (PVT) ORDINARY TABLET ON 2020-05-05
(PVT) LTD DIHYDRATE LTD-124/1 TABLETS BLISTER FOR Coated and
INDUSTRIAL AREA, uncoated tablets
KOT LAKHPAT Hard gelatin
LAHORE PAKISTAN capsules
Powders for oral
suspension
489 NDA/MAL/H WILSHIRE HEALTHCARE XAAR PREGABALI 100MG WILSHIRE PAKISTAN ORAL SOLID 1.0X4.0X5.0 5/29/2019 GMP EXPIRED NONE
DP/6959 LABORATORIES LTD. N LABORATORIES (PVT) ORDINARY CAPSULE ON 2020-05-05
(PVT) LTD LTD-124/1 CAPSULES BLISTER FOR Coated and
INDUSTRIAL AREA, uncoated tablets
KOT LAKHPAT Hard gelatin
LAHORE PAKISTAN capsules
Powders for oral
suspension
490 NDA/MAL/H WILSHIRE HEALTHCARE APPERIZE MULTI- MULTI- WILSHIRE PAKISTAN ORAL LIQUID 1.0X120.0 1/15/2019 GMP EXPIRED NONE
HP/7974 LABORATORIES LTD. SYRUP INGREDIENT INGREDIEN LABORATORIES (PVT) ORDINARY ML BOTTLE ON 2020-05-05
(PVT) LTD 120ML T LTD-124/1 SYRUPS FOR Coated and
INDUSTRIAL AREA, uncoated tablets
KOT LAKHPAT Hard gelatin
LAHORE PAKISTAN capsules
Powders for oral
suspension
491 NDA/MAL/H WILSHIRE HEALTHCARE X-TREME TRIBULUS 300MG + WILSHIRE PAKISTAN ORAL SOLID 1.0X3.0X10. 4/23/2019 GMP EXPIRED NONE
HP/9095 LABORATORIES LTD. TERRESTRIS 40MG + LABORATORIES (PVT) ORDINARY 0 TABLET ON 2020-05-05
(PVT) LTD EXTRACT+ 15MG + 30 LTD-124/1 TABLETS BLISTER FOR Coated and
GINGSENG I.U + 10MG INDUSTRIAL AREA, uncoated tablets
EXTRACT + + 33MCG KOT LAKHPAT Hard gelatin
ZINC + LAHORE PAKISTAN capsules
VITAMIN E + Powders for oral
GINKGO suspension
492 NDA/MAL/H WILSHIRE HEALTHCARE BENZIM MULTI- N/A WILSHIRE PAKISTAN ORAL LIQUID 1.0X120.0 12/3/2016 GMP EXPIRED NONE
HP/6850 LABORATORIES LTD. NATURAL INGREDIENT LABORATORIES ORDINARY ML BOTTLE ON 2020-05-05
(PVT) LTD SYRUP LIMITED-124/1- SYRUPS FOR Coated and
120ML INDUSTRIAL ESTATE, uncoated tablets
KOT LAKHPAT, Hard gelatin
LAHORE, PAKISTAN capsules
Powders for oral
suspension
493 NDA/MAL/H WILSHIRE HEALTHCARE DE-FLU MULTIINGR N/A WILSHIRE INDIA ORAL LIQUID 1.0X120.0 12/3/2016 GMP EXPIRED NONE
HP/6852 LABORATORIES LTD. SYRUP EDIENT LABORATORIES ORDINARY ML BOTTLE ON 2020-05-05
(PVT) LTD 120ML LIMITED-124/1- SYRUPS FOR Coated and
INDUSTRIAL ESTATE, uncoated tablets
KOT LAKHPAT, Hard gelatin
LAHORE, PAKISTAN capsules
Powders for oral
suspension
494 NDA/MAL/H WILSHIRE HEALTHCARE LIV-LONG MULTIINGR N/A WILSHIRE PAKISTAN ORAL SOLID 1.0X3.0X10. 7/1/2016 GMP EXPIRED NONE
HP/6853 LABORATORIES LTD. TABLET EDIENT LABORATORIES ORDINARY 0 TABLET ON 2020-05-05
(PVT) LTD LIMITED-124/1- TABLETS BLISTER FOR Coated and
INDUSTRIAL ESTATE, uncoated tablets
KOT LAKHPAT, Hard gelatin
LAHORE, PAKISTAN capsules
Powders for oral
suspension
495 NDA/MAL/H SEARLE HEALTHCARE SELANZ - SR LANSOPRAZ 30MG SEARLE PAKISTAN PAKISTAN ORAL SOLID 1.0X1.0X7.0 7/1/2005 GMP EXPIRED NONE
DP/2028 PAKISTAN LTD. OLE LIMITED-PLOT 35KM, ORDINARY CAPSULE ON 2020-05-12
LIMITED MULTAN ROAD, CAPSULES BLISTER FOR Non Beta-
LAHORE - PAKISTAN lactam Tablets
(Coated and
Uncoated) Hard
Gelatin Capsules
Oral liquids