I/We Mr. Sajjad Hussain of ARRETA PHARMACEUTICALS (Pvt) Ltd.

Plot #
13,Street No: N-5, RCCI,Industrial Estate ,Rawalpindi. here by apply for the
registration of the drug, namely AREMAB 135mg TABLET
Detail of which are enclosed.

Date 20 TH September, 2019

Signed…………………
Place Islamabad
ENCLOSURE OF THE APPLICATION FOR REGISTRATION OF A DRUG FOR
LOCAL MAUFACTURE.
Dosage form TABLET

1-Name and address of the manufacturer (applicant)

M/S ARRETA PHARMACEUTICALS (Pvt) Ltd. Plot # 13,Street No:

N-5, RCCI,Industrial Estate ,Rawalpindi

2-Brand (proprietary) name of drug

AREMAB 135mg TABLET

3-The chemical name(s) and as appropriate and available the established

(generic) names and synonyms of the drug.

PubChem CID: 17683

Structure:

Find Similar Structures

 Molecular Formula: C25H36ClNO5

MEBEVERINE HYDROCHLORIDE
2753-45-9
Mebeverine HCl
Chemical Names:
Duspatalin
Duspatal

Molecular Weight: 466 g/mol

IUPAC Name
4-[ethyl-[1-(4-methoxyphenyl) propan-2-yl] amino] butyl 3,4-dimethoxybenzoate;
hydrochloride

InChI
InChI=1S/C25H35NO5.ClH/c1-6-26(19(2)17-20-9-12-22(28-3)13-10-20)15-7-8-16-31-
25(27)21-11-14-23(29-4)24(18-

4-Strength of active ingredient(s) per unit, e.g. each tablet or 5 ml, etc.
contains.
Each film-coated tablet contains:
Mebeverine Hydrochloride…….135mg.

5-Pharmacological group.
(Gastro-Intestinal Drugs)
Anti- Spasmodic
Acid peptic and motility disorders
6-Recommended clinical use

See Annexure A

7-Proposed route of administration.

By mouth (ORAL)
8-Proposed dosage.
 See Annexure A

9-Proposed shelf life of the drug.

Two Years
10-Proposed storage condition of finished product.
Store at cool and dry place.
Protect from light and keep away from the reach of children.

11-Unit price of the drug, e.g. per tablet, capsule, per 5 ml etc.

As per S.R.O

12-In case of international availability, provide the following information

namely:
a. Name of the drug
b. Country where sold/ registered and
c. Name of company selling the drug or having registration to
manufacture (include supporting documents/proof of international
registration)

COLOFAC 135 MG TABLETS

 Australia
 Ireland
 Malta
 New Zealand

 South Africa
 Thailand
 United Kingdom

Manufactured by Mylan Laboratories SAS, Route de Belleville, Lieu dit

Millard, 01400 Carillon-sur-Chalaronne, France.

Procured from within the EU by Product Licence Holder: MPT Pharma Ltd,
Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.

Repackaged by MPT Pharma Ltd.

13-Brand name(s) of the drug available in Pakistan.

Registration No Brand Name

024505 SPASLER NEO TAB
011166 Mevrin-135 Tablet

14- Name of company manufacturing in Pakistan.

AGP KARACHI
S.J&G. FAZUL ELLAHI KARACHI

15-Composition (active & excepients) including statement of the quantitative

composition, giving the weight or measure for each active substance used in
the manufacture of the dosage

See Annexure B

16-Outline of method of manufacture.

See Annexure C

17-Persons under whose direct supervision and control the drug is

manufactured with the following details, namely:
d. Total number of technical staff and
e. Name qualification and designation of the person directly
supervising the manufacture of the drug applied for registration and
any change shall be properly documented and record maintained
by the manufacturer.

See Annexure D

18-Name of equipment that will be used in the manufacturing of the drug.

CGMP compliance.
 MANUFACTURING EQUIPMENT:

1. GENERAL TABLET SECTION:

1.1 Mixing / Granulation / Drying:
Name of Equipment Quantity CGMP Complience
YES No
a. Z- Mixer 01
b. Double Cone Mixer 01
c. Oscillating Granulator 01
d. Wet Granulator 01
e. Tray Truck Dryer 01
1.2 Compression:
Name of Equipment Quantity
a. Zp-19 01
b. Vacuum Cleaner 01
c. Dehumidifier 01
d. Weighing Balance 01
e. RH Meter 01

1.3 Coating:
Name of Equipment Quantity
a. Coating Pan 01
b. Hot Air Blower 01
c. Coating Solution Container 01
d. Coating Gun 01
e. Pressure Tank 01

2. PSYCHOTROPIC TABLET SECTION:

2.1 Mixing / Granulation / Drying:

Name of Equipment Quantity
 a. Z- Mixer 01
b. Double Cone Mixer 01
c. Oscillating Granulator 01
d. Wet Granulator 01
e. Tray truck Dryer 01

2.2 Compression:
Name of Equipment Quantity
a. Zp-17 01
b. Vacuum Cleaner 01
c. Dehumidifier 01
d. Weighing Balance 01
e. RH Meter 01
f. Compressor 01

2.3 Coating:
Name of Equipment Quantity
a. Coating Pan 01
b. Hot Air Blower 01
c. Coating Solution Container 01
d. Coating Gun 01
e. Pressure Tank 01
f. Compressor 01

3. TABLET PACKING HALL

Name of Equipment Quantity
a. Blister machine 01
b. Convery Belt 01
c. Compressor 01
 4. WARE HOUSE:
Name of Equipment Quantity
a. Weighing Balance 02
b. Dehumidifier 01
c. Scoops 05
d. Fire Extinguisher 01

19-Full description of the specifications and analytical methods necessary

to assure the identity, strength, quality, purity and homogeneity through out
the shelf life of the drug product.

See Annexure E

20-Name, qualification and designation of the persons who will be responsible for
the quality control of the drug.

See Annexure F

21- Description of the equipment to be used for the quality control of the
active raw material and the finished products

22-Labeling and prescribing information (to be mentioned on the pack/leaflet)

specimen or draft shall be submitted for the following class as of drugs,
namely:
a. C.N.S stimulant
b. Drug affecting utrine motility
c. Drug inhibiting hormonal production.
 d. Hormonal and other steroidal preparation excluding preparations for
external and topical use.
e. Narcotic drugs as per single convention on narcotic drugs 1961 and
f. Psychotropic substances, 1971. (Specimen of label to be submitted as
soon as production starts)

NOT APPLICABLE

23- Facility of water processing with specifications.

See Annexure H

24-Environment control processing with details.

See Annexure I

25-Type of container and packaging.

See Annexure J

26- A copy of last Inspection Report conducted by the Ministry of Health

See Annexure K

UNDERTAKING

I / We hereby undertake that the above given information is true and correct to the
best of my / our knowledge and belief. Production Manager Quality Control
Manager
Production Manager Quality Control Manager”;