NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA ANALYTICAL DEVELOPMENT MONTHLY REPORT & PLAN: JANUARY 2022 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA ANALYTICAL DEVELOPMENT Monthly Report December 2021 Nuvista Analytical Development Department Assay Method Development SI. No. 01 Activity Mucopolysaccharide Polysulphate (MPS) 0.2% + Salicylic Acid 2% Gel TOTAL DONE : 0 Status Done Not Done Pending due to Supplier method Done By Pending 30.01.22 TOTAL Running : 1 Dissolution Method Development 01 Ferric Maltol Capsule TOTAL DONE : 0 Running 30.01.22 TOTAL Running : 1 Assay Method Validation Protocol Preparation 01 02 03 Testerone Injection Done Shakhawat Dequalinium Chloride Tablet Done Safiqul Islam 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 TOTAL DONE : 01 Done TOTAL PENDING : 0 Shakhawat NAD Monthly Report: December 2021 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT 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 TOTAL DONE : 1 Running 20.01.22 TOTAL PENDING : 0 6 Month Stability Data Preparation 01 Dekalin VT Done 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) 01 Cyproterone acetate 50 mg Tablet TOTAL DONE : 1 Done Rukhsana TOTAL PENDING : 0 NAD Monthly Report: December 2021 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT Stability Sample Analysis (1M Stability Test) 01 Pending Ferric Maltol 30 mg Iron Capsule TOTAL DONE : 0 30.01.22 TOTAL PENDING : 1 Stability Sample Analysis (3M Stability Test) 01 Ulipristal acetate 30 mg Tablet Running TOTAL DONE : 01 20.01.22 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 Done NDQ Done NDQ 03 04 Preparation & recording of analytical lab note book Preparation & review of analytical method verification / validation protocol Total Done : 02 Total Pending: 02 NAD Monthly Report: December 2021 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT New Product Technology Transfer DONE BY: Product/material name: 01 Done N/A N/A DTL Sample Submission Product/Material Name: DTL Test Done by: Obeticholic acid 5 & 10 mg tablet Safiqul Islam Raw Materials Test Material Name Source Material Test Responsible Person 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 NAD Monthly Report: December 2021 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT Mirogabalin Besylate Received Safiqul Islam Relugolix Received Safiqul Islam 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 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA ANALYTICAL DEVELOPMENT Monthly Plan January 2022 Nuvista Analytical Development Department Assay Method Development Sr. No. 01 Particulars Status Mucopolysaccharide Polysulphate (MPS) 0.2% + Salicylic Acid 2% Gel Running 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 03 Elagolix 200 mg tablet Running 04 Ulipristal acetate 30mg tablet STP Preparation & Approval 01 Ferric Maltol Capsule Running 02 Ferric Derisomaltose injection Running Remarks NAD Monthly Plan: January 2022 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT 03 Calcium Folinate 5 & 15 mg tablet Running 04 Caprogen DS injection Running 05 Ulipristal acetate 30 mg tablet Running 06 Elagolix 200 mg tablet Running 07 Deaca Duraboline injection Running Comparative Dissolution Analysis 01 Doxavit 10 DR Tablet Done 3 Month Stability Data Preparation Sr. No. Particulars Status 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 6 Month Stability Data Preparation 01 Elagolix 150 mg Tablet Running 02 Delanzo 30 Capsule Running Stability Sample Analysis (Initial) 01 Cyproterone acetate 50 mg tablet Running Remarks NAD Monthly Plan: January 2022 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT 02 Clascoterone INN 1% Cream Running 03 Abametapir INN 0.74% Lotion Running 04 Mucopolysaccharide Polysulphate (MPS) 0.2% + Salicylic Acid 2% Gel Running 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: 01 Water Purification system Running 02 Handling, washing and calibration of Glassware Running Due because of machine under installation NAD Monthly Plan: January 2022 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT 03 Operation, cleaning and calibration procedure for Micropipette Running 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 NAD Monthly Plan: January 2022 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA 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 NAD Monthly Plan: January 2022 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT List of Expired Standard[Next 3 Month] Impurity Sr. No. Name of Impurity Batch Number 01 Elagolix Sodium OTF-V Impurity/A044/11 19/155/376OTF-I/A044/12 19/155/388 02 Ethinyl Estradiol Related Compound B R068F0 Amount Expiry Date 20 mg 20 mg 20 mg 20 mg 20.08.22 20 mg 28-FEB-2022 RS/CRS Sr. No. Name of RS/CRS Batch No./ Lot No. Amount (mg) Expiry Date 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 06 Hydroxyprogesterone Caproate R058T0 200 31-MAY-2021 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 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA ANALYTICAL DEVELOPMENT Monthly Report December 2021 Nuvista Product Development Department Formulation Development Trial SI. No. Status Activity Done Not Done Pending Remarks/ Target Date 01 Nomegestrol acetate 2.5 mg plus Estradiol 1.5mg Tablet Running By 25th January 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 Done Under Stability & SSP done by 10th Jan Done Under Stability Done Yet to Start the stability 03 04 05 Mucopolysaccharide Polysulphate (MPS) 0.2% + Salicylic Acid 2% Gel Lactic acid USP 18mg, CA USP 10mg and PBT USP 4 mg Gel Ciproterone Acetate 50 mg Tablet TOTAL DONE: 04 Products TOTAL Running: 01 Product NPD Monthly Report: December 2021 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT Product Data Sheet Preparation 01 02 Mucopolysaccharide Polysulphate (MPS) 0.2% + Salicylic Acid 2% Gel Lactic acid USP 18mg, CA USP 10mg and PBT USP 4 mg Gel Done Draft Data Sheet Done Draft Data Sheet 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 01 Water For Injection Total Done : 01 Product Done Waiting for Approval 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 NPD Monthly Report: December 2021 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT 06 Norestin Tab. Running Done By 25th January 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 Total Done : 02 Products Done By 15th January Total Pending : 03 Products 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 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA ANALYTICAL DEVELOPMENT Monthly Plan January 2022 Nuvista Product Development Department Formulation Development Trial SI. No. Activity Status Done Not Done Done By/Remarks Pending 01 Nomegestrol acetate 2.5 mg plus Estradiol 1.5mg Tablet Running Done By 25th January 02 Ferric Derisomaltose Injection 10 ml Running Done By 25th January 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 06 Magnesium Aspartate Dihydrate PFS Running Done By 25th January 07 Ciclopirox Lotion New Total Done: 00 Products Total Running: 00 Product Stability Trial & Protocol Preparation 01 Clascoterone INN 1% Cream Done Two More New trial required 02 Abametapir INN 0.74% Lotion Running Waiting for PM 03 Ciproterone Acetate 50 mg Tablet Running Yet to Start the stability 04 Thyronor 50, 75 & 100 mcg Tablet Running Yet to Start the stability Total Done: 00 Products Total Running: 02 Product NPD Monthly Plan: January 2022 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT Product Data Sheet Preparation 01 Thyronor 25 Tablet 02 Thyronor 75 Tablet 03 Thyronor 100 Tablet 04 Marvelon Tablet 05 Microlon Tablet 06 Elisa Tablet & 4 Placebo 07 Cleo 35 Tablet 08 Thyronor 50 Tablet 09 Ovostat Gold Tablet Total Done : 00 Products New New New New New New New New New Total Running: 00 Product Recipe Preparation Total Done : 00 Product Material Requisition(Resource) MI/PI Preparation Total Pending : 00 Products NPD Monthly Plan: January 2022 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT Total Done : 00 Products Total Pending : 00 Products PDR Preparation 01 Traxyl Capsule 02 Carbeshot Injection 03 Tibilon Tablet 04 Norestin Tab. 05 Testanon Injection Total Done : 00 Products Running Done By 25th Dec Running Done By 25th Dec Running Done By 25th Dec Running Done By 25th Dec Running Done By 25th Dec Total Pending : 00 Products 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 Total Done : 01 Products Total Pending : 04 Products NPD Monthly Plan: January 2022 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT 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 Commercial Batch Manufacturing Product Name/No of Batch Current Status NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA ANALYTICAL DEVELOPMENT Monthly Plan & Report January 2022 Nuvista Development Quality Department SOP Preparation & Distribution SI. No. 01 02 03 04 05 06 07 08 09 Status List of SOP on Preparation & Recording of Analytical Lab Note Book Preparation & Review of Analytical Method Verification / Validation Protocol Operation, temperature mapping & maintenance of Arctiko Refrigerator (model no.: pr1400) Waste Management of Product Development Department Setup, Operation, Cleaning & Calibration of Newtronic Stability Chamber (30°C ± 2°C & 65% ± 5% RH) Setup, Operation, Cleaning & Calibration Of Newtronic Stability Chamber (40°C ± 2°C & 75% ± 5% RH) Set Up, Operation, Cleaning And Calibration Of Thermolab Photostability Chamber Handling, washing and calibration of Glassware operation, cleaning and calibration procedure for micropipette Done Not Done Pending Remarks/ Target Date Done Done Under Review 10.01.22 Under Review 20.01.22 Under Review 25.01.22 Under Review 30.01.22 New SOP 30.01.22 New SOP 30.01.22 New SOP 30.01.22 NDQ Monthly Plan & Report: January 2022 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT Annexure Amendment Activities SI. No. List of Product Done 01 Anaroxyl Injection Done 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 Status Not Done Pending Remarks/ Target Date NDQ Monthly Plan & Report: January 2022 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT Pending calibration report status SI. No. 01 02 03 04 05 06 07 08 09 10 Status Name of the Instruments/Equipment’s No pending, all done on due date. Done Not Done Pending Remarks/ Target Date NDQ Monthly Plan & Report: January 2022 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT Calibration Schedule[Next 2 Month] SI. No. Status Name of the Instruments/Equipment’s Remarks Due date Responsibility 01 Hardness Tester 23-01-22 Khan & Deen External 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 NDQ Monthly Plan & Report: January 2022 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT NAD Logbook Status [Total Working Days: 23] SI. No. Status Name of the Instruments/Equipment’s Done Not Done Pending Total Used (Days) 01 HPLC- Prominence I plus [ID: PDT/E/028] OK -- -- 12 Days 02 HPLC- Prominence I plus [ID: PDT/E/029] OK -- -- 14 Days 03 HPLC- Prominence I [ID: PDT/E/014] OK -- -- 16 Days 04 05 06 07 08 09 10 NDQ Monthly Plan & Report: January 2022 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT Leave Status Employee Name Privilege Leave Sick Leave Last Month Provided Avail Provided Avail Privilege Leave Sick 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 Rahaman 20 3.5 14 0 0 0 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 NUVISTA PHARMA LIMITED PRODUCT DEVELOPMENT 48, TONGI I/A, GAZIPUR, BANGLADESH NUVISTA PRODUCT DEVELOPMENT Prepared By Department Designation NDQ, PDT Asst. Manager, NDQ Signature & Date Reviewed By Department Designation NAD, PDT Asst. Manager, NAD NPD, PDT Deputy Manager, NPD Signature & Date Approved By Department Designation R&D General Manager, R&D Signature & Date