NPD Plan

NUVISTA PHARMA LIMITED
PRODUCT DEVELOPMENT
48, TONGI I/A, GAZIPUR, BANGLADESH
NUVISTA ANALYTICAL DEVELOPMENT
MONTHLY REPORT & PLAN: JANUARY 2022

PRODUCT DEVELOPMENT
Monthly Report December 2021

Nuvista Analytical Development Department
Assay Method Development
Status Done By
SI. No. Activity Done Not Pending
Done
Pending 30.01.22
Mucopolysaccharide Polysulphate due to
01
(MPS) 0.2% + Salicylic Acid 2% Gel Supplier
method
TOTAL DONE : 0 TOTAL Running : 1
Dissolution Method Development
01 Ferric Maltol Capsule Running 30.01.22
TOTAL DONE : 0 TOTAL Running : 1
Assay Method Validation Protocol Preparation

01
Testerone Injection Done Shakhawat
02 Safiqul
Dequalinium Chloride Tablet Done
Islam
03
Deaca Duraboline injection Running 30.01.22
Total Done : 02 Total Running : 1
Assay Method Validation Work and Report Preparation
01 Obetacholic acid 5 & 15 mg Tablet Done Shakhawat
TOTAL DONE : 01 TOTAL PENDING : 0
STP Preparation & Approval

NAD Monthly Report: December 2021
PRODUCT DEVELOPMENT
NUVISTA PRODUCT DEVELOPMENT
01 Ferric Maltol Capsule Running 30.01.22
02 Ferric Derisomaltose injection Running 30.01.22
03 Calcium Folinate 5 & 15 mg tablet Running 30.01.22
04 Caprogen DS injection Running 30.01.22
05 Ulipristal acetate 30 mg tablet Running 30.01.22
06 Elagolix 200 mg tablet Running 30.01.22
Total done : 06 Total pending: 6
3 Month Stability Data Preparation
01 Ulipristal acetate 30 mg tablet Running 20.01.22

01 Dekalin VT Done
02 Folinic Acid 5 mg Tablet Running 20.01.22
03 Folinic Acid 5 mg Tablet Running 20.01.22
Stability Sample Analysis (Initial)

01 Cyproterone acetate 50 mg Tablet Done Rukhsana
Stability Sample Analysis (1M Stability Test)
01 Ferric Maltol 30 mg Iron Capsule Pending 30.01.22

PRODUCT DEVELOPMENT
01 Ulipristal acetate 30 mg Tablet Running 20.01.22
01 Folinic Acid 15 mg Tablet Done Rukhsana
02 Folinic Acid 5 mg Tablet Done Rukhsana
03 Roxadex 6 mg Tablet Done Rukhsana
Total Done : 03 Total Pending : 0
SOP Preparation & Approval:
Sop Name Done by
01 Water Purification system Under Preparation 30.01.22
02 Glassware management SOP Under Preparation 30.01.22
Preparation & recording of analytical

03 Done NDQ
lab note book
Preparation & review of analytical
04 method verification / validation Done NDQ
protocol
Total Done : 02 Total Pending: 02
New Product Technology Transfer
Product/material name: DONE BY:

PRODUCT DEVELOPMENT
01 N/A Done N/A
DTL Sample Submission
Product/Material Name: Done by:
DTL Test Obeticholic acid 5 & 10 mg tablet Safiqul Islam
Raw Materials Test

Source Material
Material Name Responsible Person
Test
Lactic Acid Done Safiqul Islam
Citric Acid Done Safiqul Islam
Potassium Biterterate Done Safiqul Islam
Calcium Folinate Done Safiqul Islam
Feric maltol Done Safiqul Islam
Total Test Done: 04 Materials
Raw Materials Received
Sorbitan Monooleate Received Safiqul Islam
White Soft Paraffin BP Received Safiqul Islam
Liquid Paraffin BP Received Safiqul Islam
Mirogabalin Besylate Received Safiqul Islam
Relugolix Received Safiqul Islam

PRODUCT DEVELOPMENT
Ozenoxacin Received Safiqul Islam
Lanoline Anhydrous EP Received Safiqul Islam
Eflornithine Hydrochloride Monohydrate Received Safiqul Islam
Macrogol 3350 Received Safiqul Islam
Ceto Steryl Alcohol Received Safiqul Islam
Estradiol USP Micronized Received Safiqul Islam
Total Material Received 11 Materials

PRODUCT DEVELOPMENT
Monthly Plan January 2022

Nuvista Analytical Development Department
Assay Method Development
Sr. No. Particulars Status Remarks
Mucopolysaccharide Polysulphate (MPS)

01 Running
0.2% + Salicylic Acid 2% Gel
Dissolution Method Development
01 Ferric Maltol Capsule Running
Assay Method Validation Protocol Preparation

01 Deaca Duraboline injection Running
02 Elagolix 200 mg tablet Running
03 Ulipristal acetate 30mg tablet Running
Assay Method Validation Work and Report Preparation

01 Dekalin VT tablet Running
02 Testanone injection Running
04 Ulipristal acetate 30mg tablet
STP Preparation & Approval

01 Ferric Maltol Capsule Running
02 Ferric Derisomaltose injection Running

NAD Monthly Plan: January 2022
PRODUCT DEVELOPMENT
03 Calcium Folinate 5 & 15 mg tablet Running
04 Caprogen DS injection Running
05 Ulipristal acetate 30 mg tablet Running
07 Deaca Duraboline injection Running
Comparative Dissolution Analysis
01 Doxavit 10 DR Tablet Done

Sr. No. Particulars Status Remarks
01 Thyronor 12.5 mcg tablet Running
02 Calcium Dobesilate 500 mg Capsule Running
03 Ferric maltose 30 mg iron Capsule Running
04 Ferric derisomaltose 100 mg/ml injection Running

01 Elagolix 150 mg Tablet Running
02 Delanzo 30 Capsule Running
Stability Sample Analysis (Initial)
01 Cyproterone acetate 50 mg tablet Running

PRODUCT DEVELOPMENT
02 Clascoterone INN 1% Cream Running
03 Abametapir INN 0.74% Lotion Running
Mucopolysaccharide Polysulphate (MPS)

04 Running
0.2% + Salicylic Acid 2% Gel
05 Thyronor 50 , 75 & 100 mcg tablet Running
Stability Sample Analysis (1 Month)
01 LA, CA & PBT Gel Running
02 (MPS) 0.2% + Salicylic Acid 2% Gel Running
Stability Sample Analysis (3 Month)
01 Thyronor 12.5 mcg tablet Running
02 Calcium Dobesilate 500 mg Capsule Running
03 Ferric maltose 30 mg iron Capsule Running
04 Ferric derisomaltose 100 mg/ml injection Running
Stability Sample Analysis (6 Months)
01 Delanzo 30 Capsule Running
02 Elagolix 150 mg Tablet Running
SOP Preparation & Approval:

Due because of machine
01 Water Purification system Running
under installation
Handling, washing and calibration of
02 Running
Glassware
PRODUCT DEVELOPMENT
Operation, cleaning and calibration

03 Running
procedure for Micropipette
Raw Materials Test

Product/Material Name Done by
QC Selected
1 Carbopol 980 NF Polymer Running
2 Glycerine BP Running
3 Lipoid SPE-3 Running
4 Hydroxy Propyl Betadex Running
5 Kolliphor HS 15 Running
6 Lansoprazole WS Running
7 Sorbitan Monooleate Running
8 White Soft Paraffin BP Running
9 Liquid Paraffin BP Running
10 Mirogabalin Besylate Running
11 Relugolix Running
12 Ozenoxacin Running
13 Lanoline Anhydrous EP Running
14 Eflornithine Hydrochloride Monohydrate Running

PRODUCT DEVELOPMENT
15 Macrogol 3350 Running
16 Ceto Steryl Alcohol Running
17 Estradiol USP Micronized Running
New Product Technology Transfer
N/A
DTL Sample Preparation
Product Name Done by
Elagolix 200 mg Tablet To be Submit at DTL by this month
Obeticholic Acid 5 & 10 mg tablet Done
List of Expired Standard[Next 3 Month]

PRODUCT DEVELOPMENT
Impurity
Sr.
Name of Impurity Batch Number Amount Expiry Date
No.
20 mg
OTF-V Impurity/A044/11
20 mg
01 Elagolix Sodium 19/155/376OTF-I/A044/12 20.08.22
20 mg
19/155/388
20 mg
Ethinyl Estradiol Related

02 R068F0 20 mg 28-FEB-2022
Compound B
RS/CRS
Sr.
Name of RS/CRS Batch No./ Lot No. Amount (mg) Expiry Date
No.
01 Cabergoline USP F0H240 125 Current
02 Estradiol USP R025F0 500 Current
03 Estrone R030H0 200 31-JAN-2022
04 Drospirenone R04250 200 31-JAN-2022
05 Progesterone I2J239 200 Current

Hydroxyprogesterone
06 R058T0 200 31-MAY-2021
Caproate
07 Estradiol Valerate M0M467 100 30-JUN-2021
08 Desogestrel R04270 200 Current
09 Lansoprazole I0M366 150 31-AUG-2022
10 Citric Acid R062M0 400 Current
11 Eflornithine Hydrochloride R06840 150 30-SEP-2022

PRODUCT DEVELOPMENT
Monthly Report December 2021

Nuvista Product Development Department
Formulation Development Trial
SI. Status
No. Remarks/
Activity
Done Not Target Date
Pending
Done
Nomegestrol acetate 2.5 mg plus
01 Running By 25th January
Estradiol 1.5mg Tablet
02 Ferric Derisomaltose Injection 10 ml Running By 25th January
03 Crisaborole 2% Ointment Running By 15th January
04 Estriol 0.01% w/w Cream Running By 25th January
05 Eflrnithine HCl 11.5% Cream Running By 25th January
06 Magnesium Aspartate Dihydrate PFS Running By 25th January
07 Thyronor 50, 75 & 100 mcg Tablet Done
TOTAL DONE: 01 Products TOTAL Running: 06 Products
Stability Trial & Protocol Preparation

01 Clascoterone INN 1% Cream Done Under Stability
02 Abametapir INN 0.74% Lotion Running Waiting for PM

Mucopolysaccharide Polysulphate Under Stability &
03 Done
(MPS) 0.2% + Salicylic Acid 2% Gel SSP done by 10th Jan
Lactic acid USP 18mg, CA USP 10mg
04 Done Under Stability
and PBT USP 4 mg Gel
Yet to Start the
05 Ciproterone Acetate 50 mg Tablet Done
stability
TOTAL DONE: 04 Products TOTAL Running: 01 Product
NPD Monthly Report: December 2021
PRODUCT DEVELOPMENT
Product Data Sheet Preparation

Mucopolysaccharide Polysulphate
01 Done Draft Data Sheet
(MPS) 0.2% + Salicylic Acid 2% Gel
Lactic acid USP 18mg, CA USP 10mg
02 Done Draft Data Sheet
and PBT USP 4 mg Gel
03 Clascoterone INN 1% Cream Done Draft Data Sheet
04 Abametapir INN 0.74% Lotion Done Draft Data Sheet
05 Ciproterone Acetate 50 mg Tablet Done Draft Data Sheet
06 Femipil Tablet Done Final Data Sheet
07 Dekalin VT Done Final Data Sheet
TOTAL DONE : 07 Products TOTAL Running : 00 Product
Recipe Preparation
Waiting for
01 Water For Injection Done
Approval
Total Done : 01 Product TOTAL PENDING : 00 Products
Material Requisition(Resource)
MI/PI Preparation
01 Deflazacort Tablet Done
02 Adam 20 Tablet Done
TOTAL DONE : 00 Products TOTAL PENDING : 00 Products
PDR Preparation
01 Caprogen Injection Done
02 Roxadex Injection Done
03 Traxyl Capsule Running Done By 25th January
04 Carbeshot Injection Running Done By 25th January
05 Tibilon Tablet Running Done By 25th January
06 Norestin Tab. Running Done By 25th January

NPD Monthly Report: December 2021
PRODUCT DEVELOPMENT
07 Testanon Injection Running Done By 25th January
Total Done : 02 Products Total Pending : 05 Products
Sop Preparation
Total Done : 00 SOPs Total Pending : 00 Sops
BMR & BPR Preparation

01 Linaclotide Capsule Running Done By 25th January
02 Calcium Dobesilate Capsule Running Done By 25th January
03 Dekalin VT Done
04 Hipomax Tablet Done
05 Magnox Tablet Running Done By 15th January
Annexure Preparation/Amendment
Calcium Dobesilate 500 Capsule (Hemroid
For New Inclusion
Capsule )
TOTAL DONE : 01 Products Total Pending : 00 Products
Commercial Batch Manufacturing

Product Name/No of Batch Current Status
Elagox Tablet Third Batch Manufacturing Done

Monthly Plan January 2022
Nuvista Product Development Department
Formulation Development Trial
SI. Status
No.
Activity Done By/Remarks
Done Not Done Pending
Nomegestrol acetate 2.5 mg plus

01 Running Done By 25th January
Estradiol 1.5mg Tablet
Ferric Derisomaltose Injection 10
ml
03 Crisaborole 2% Ointment Running Done By 15th January
04 Estriol 0.01% w/w Cream Running Done By 25th January
05 Eflrnithine HCl 11.5% Cream Running Done By 25th January
Magnesium Aspartate Dihydrate

PFS
07 Ciclopirox Lotion New
Total Done: 00 Products Total Running: 00 Product
Stability Trial & Protocol Preparation

Two More New trial
01 Clascoterone INN 1% Cream Done
required
02 Abametapir INN 0.74% Lotion Running Waiting for PM
Yet to Start the

03 Ciproterone Acetate 50 mg Tablet Running
stability
Yet to Start the
04 Thyronor 50, 75 & 100 mcg Tablet Running
stability
Total Done: 00 Products Total Running: 02 Product
Product Data Sheet Preparation
01 Thyronor 25 Tablet New
New
02 Thyronor 75 Tablet
New
NPD Monthly Plan: January 2022
PRODUCT DEVELOPMENT
New
04 Marvelon Tablet
New
05 Microlon Tablet
Elisa Tablet & New

06
4 Placebo
New
07 Cleo 35 Tablet
New
New
09 Ovostat Gold Tablet
Total Done : 00 Products Total Running: 00 Product
Recipe Preparation
Total Done : 00 Product Total Pending : 00 Products
Material Requisition(Resource)
MI/PI Preparation
PDR Preparation
Running
01 Traxyl Capsule Done By 25th Dec
Running Done By 25th Dec

02 Carbeshot Injection
PRODUCT DEVELOPMENT

03 Tibilon Tablet

04 Norestin Tab.

05 Testanon Injection
SOP Preparation
Total Done : 00 SOPs Total Pending : 00 SOPs
BMR & BPR Preparation
01 Osmifen Tablet New Sumon Kumar Datta
02 Linaclotide Capsule Running Done By 20th January
03 Calcium Dobesilate Capsule Running Done By 20th January
04 Dekalin VT Done Sumon Kumar Datta
05 Elagox Tablet New Sumon Kumar Datta
Annexure Preparation/Amendment
01 Calcium Folinate 5 mg Tablet Done Submitted
02 Calcium Folinate 15 mg Tablet Done Submitted
TOTAL DONE : 00 Products TOTAL PENDING: 00 Products

PRODUCT DEVELOPMENT
Commercial Batch Manufacturing
Product Name/No of Batch Current Status

Monthly Plan & Report January 2022
Nuvista Development Quality Department
SOP Preparation & Distribution

Status
SI. Remarks/
List of SOP on Not
No. Done Pending Target Date
Done
Preparation & Recording of Analytical
01 Done
Lab Note Book
Preparation & Review of Analytical
02 Method Verification / Validation Done
Protocol
Operation, temperature mapping &
Under
03 maintenance of Arctiko Refrigerator 10.01.22
Review
(model no.: pr1400)
Waste Management of Product Under
04 20.01.22
Development Department Review
Setup, Operation, Cleaning &
Under
05 Calibration of Newtronic Stability 25.01.22
Review
Chamber (30°C ± 2°C & 65% ± 5% RH)
Setup, Operation, Cleaning &
Under
06 Calibration Of Newtronic Stability 30.01.22
Review
Chamber (40°C ± 2°C & 75% ± 5% RH)
Set Up, Operation, Cleaning And
New
07 Calibration Of Thermolab Photostability 30.01.22
SOP
Chamber
Handling, washing and calibration of New
08 30.01.22
Glassware SOP
operation, cleaning and calibration New
09 30.01.22
procedure for micropipette SOP
Annexure Amendment Activities

Status Remarks/
SI.
List of Product Not Target
No. Done Pending
Done Date
01 Anaroxyl Injection Done
NDQ Monthly Plan & Report: January 2022
PRODUCT DEVELOPMENT
02 Carbeshot Injection Done
03 Deca -Durabolin Injection Done
04 Durabolin Injection Done
05 Ketoshot 30 Injection Done
06 Linda-S Ds Injection Done
07 Ofmit Tablet Done
08 Roxadex 5 Injection Done
09 Testanon Injection Done
10 Visceralgine Injection Done
Pending calibration report status

Status
SI. Remarks/
Name of the Instruments/Equipment’s Not
No. Done Pending Target Date
Done
01 No pending, all done on due date.

PRODUCT DEVELOPMENT
02
03
04
05
06
07
08
09
10
Calibration Schedule[Next 2 Month]
Status
SI.
Name of the Instruments/Equipment’s Remarks
No.
Due date Responsibility
01 Hardness Tester 23-01-22 Khan & Deen External

PRODUCT DEVELOPMENT
02 Electrolab Dissolution Tester 11-02-22 SAKA Int’l Ltd. External
03 Electrolab Disintegration Tester 04-02-22 In House Internal
04
05
06
07
08
09
10
NAD Logbook Status [Total Working Days: 23]
Status
SI. Total Used
Name of the Instruments/Equipment’s
No. Not (Days)
Done Pending
Done
HPLC- Prominence I plus
01 OK -- -- 12 Days
[ID: PDT/E/028]
HPLC- Prominence I plus
02 OK -- -- 14 Days
[ID: PDT/E/029]
PRODUCT DEVELOPMENT
HPLC- Prominence I
03 OK -- -- 16 Days
[ID: PDT/E/014]
04
05
06
07
08
09
10
Leave Status
Privilege Leave Sick Leave Last Month

Employee Name
Privilege Sick
Provided Avail Provided Avail
Leave Leave
Sumon Kumar Datta 20 6.5 14 2 0.5 0
Rukhsana Nazneen 20 7 14 2 0 1
Md. Aslam Mia 20 2.5 14 0 0.5 0

Md. Shajadur 20 3.5 14 0 0 0
PRODUCT DEVELOPMENT
Rahaman
Shakawat Hossain 20 9 14 3 2 0
Roshidul Islam 20 N/A 14 N/A N/A N/A
Md. Safiqul Islam 20 4 14 8 0 1
Ramanath Kumar 20 8 14 3 0.5 0

PRODUCT DEVELOPMENT
Prepared By
Department Designation Signature & Date
NDQ, PDT Asst. Manager, NDQ
Reviewed By
NAD, PDT Asst. Manager, NAD
NPD, PDT Deputy Manager, NPD
Approved By
R&D General Manager, R&D

NPD Plan

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NUVISTA PHARMA LIMITED

MONTHLY REPORT & PLAN: JANUARY 2022

Monthly Report December 2021

TOTAL DONE : 0 TOTAL Running : 1

Dissolution Method Development

01 Ferric Maltol Capsule Running 30.01.22

TOTAL DONE : 0 TOTAL Running : 1

Assay Method Validation Protocol Preparation

Total Done : 02 Total Running : 1

Assay Method Validation Work and Report Preparation

01 Obetacholic acid 5 & 15 mg Tablet Done Shakhawat

TOTAL DONE : 01 TOTAL PENDING : 0

STP Preparation & Approval

01 Ferric Maltol Capsule Running 30.01.22

02 Ferric Derisomaltose injection Running 30.01.22

03 Calcium Folinate 5 & 15 mg tablet Running 30.01.22

04 Caprogen DS injection Running 30.01.22

05 Ulipristal acetate 30 mg tablet Running 30.01.22

06 Elagolix 200 mg tablet Running 30.01.22

Total done : 06 Total pending: 6

3 Month Stability Data Preparation

01 Ulipristal acetate 30 mg tablet Running 20.01.22

TOTAL DONE : 1 TOTAL PENDING : 0

6 Month Stability Data Preparation

02 Folinic Acid 5 mg Tablet Running 20.01.22

03 Folinic Acid 5 mg Tablet Running 20.01.22

TOTAL DONE : 1 TOTAL PENDING : 2

Stability Sample Analysis (Initial)

TOTAL DONE : 1 TOTAL PENDING : 0

Stability Sample Analysis (1M Stability Test)

01 Ferric Maltol 30 mg Iron Capsule Pending 30.01.22

TOTAL DONE : 0 TOTAL PENDING : 1

Stability Sample Analysis (3M Stability Test)

01 Ulipristal acetate 30 mg Tablet Running 20.01.22

TOTAL DONE : 01 TOTAL PENDING : 0

Stability Sample Analysis (6M Stability Test)

01 Folinic Acid 15 mg Tablet Done Rukhsana

02 Folinic Acid 5 mg Tablet Done Rukhsana

03 Roxadex 6 mg Tablet Done Rukhsana

Total Done : 03 Total Pending : 0

SOP Preparation & Approval:

Sop Name Done by

01 Water Purification system Under Preparation 30.01.22

02 Glassware management SOP Under Preparation 30.01.22

Preparation & recording of analytical

New Product Technology Transfer

Product/material name: DONE BY:

01 N/A Done N/A

DTL Sample Submission

Product/Material Name: Done by:

DTL Test Obeticholic acid 5 & 10 mg tablet Safiqul Islam

Raw Materials Test

Lactic Acid Done Safiqul Islam

Citric Acid Done Safiqul Islam

Potassium Biterterate Done Safiqul Islam

Calcium Folinate Done Safiqul Islam

Feric maltol Done Safiqul Islam

Total Test Done: 04 Materials

Raw Materials Received

Sorbitan Monooleate Received Safiqul Islam

White Soft Paraffin BP Received Safiqul Islam

Liquid Paraffin BP Received Safiqul Islam

Mirogabalin Besylate Received Safiqul Islam