List of Antihepatitis Pharmaceutical Products (Included to Support Global Fund Policy for Co-Infections and Co-Morbidities)

List Of Antihepatitis Pharmaceutical Products (included to support Global Fund Policy for Co-Infections and Co-Morbidities)

Edition: Version 22- 14 July 2021 List of A & B Products

As from the version 4, please note that we consider under

Supplier / Manufacturer : Marketing authorization/ product authorization or license holder

Manufacturing Site: The Site responsible for the release of the FPP

Global WHO International Non- Strength/ Dosage Supplier/ Ref. Fund QA Prequalificatio Manufacturing site Country Material Pack proprietary name Dose form Manufacturer(s) No Standard n/ SRA

Astra Zeneca, Indiana Daclatasvir(dihydrochloride) 18 30mg Tablet BMS Pharma UK A-B Yes Batch release:BMS Italy USA Blister 28 (2x14's)

F- 4 & F-12, MIDC, Malegaon, Mylan Laboratories Sinnar, Nashik - 422 113 HDPE bottle ; Alu- Daclatasvir(dihydrochloride) 30 mg Tablet A HP015 India 28; 10x1 Limited Maharashtra PVC/PVdC blister

Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Blister, Alu-PVC/Aclar ; Daclatasvir(dihydrochloride) 30 mg Tablet Hetero labs Limited A HP011 India 10x10; 28x1 Village, Jadcherla (M), Bottle, HDPE Mahaboob Nagar District, Telangana, 509 301

Plot No. A-42 (Unit II), MIDC, Patalganga, District - Raigad, HDPE bottle ; Alu- Daclatasvir(dihydrochloride) 30 mg Tablet Cipla Ltd A HP021 India 28; 14x2 Maharashtra, PVC/PE/PVDC blister Pin code: 410 220

Edition: Version 22, 14 July 2021 List of hepatitis drugs Laurus Labs Limited, Laurus Labs Ltd, (Unit-2), 2nd Floor, Serene Plot No:19, 20 & 21, Chambers, Road No. Western Sector, APSEZ, Daclatasvir(dihydrochloride) 30 mg Tablet 7, Banjara Hills, A HP027 Atchutapuram India Bottle, HDPE 28x1, 500x1 Hyderabad, Mandal,Visakhapatnam- Telangana, 500 034, District, Andhra Pradesh, India 531011, India Astra Zeneca Pharmaceuticals LP, 4601 Highway 62 East, Mount Bristol-Myers Squibb Daclatasvir (dihydrochloride) 60mg Tablet A-B HP008 Vernon, Indiana, 47620, USA Blister, Alu/PVC-ACLAR 14x2, 28x1 Company USA Bristol-Myers Squibb (BMS), Contrada Fontana

Astra Zeneca, Indiana Daclatasvir(dihydrochloride) USA Blister 28 (2x14's) 19 60mg Tablet BMS Pharma UK A-B Yes Batch release:BMS Italy

F- 4 & F-12, MIDC, Malegaon, Mylan Laboratories HDPE bottle ; Alu- Daclatasvir(dihydrochloride) 60 mg Tablet A HP016 Sinnar, Nashik - 422 113 India 28; 10x1 Limited PVC/PVdC blister Maharashtra

Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Blister, Alu-PVC/Aclar ; Daclatasvir(dihydrochloride) 60 mg Tablet Hetero labs Limited A HP012 India 10x10; 28x1 Village, Jadcherla (M), Bottle, HDPE Mahaboob Nagar District, Telangana, 509 301

Plot No. A-42 (Unit II), MIDC, Patalganga, District - Raigad, HDPE bottle ; Alu- Daclatasvir(dihydrochloride) 60 mg Tablet Cipla Ltd A HP022 India 28; 14x2 Maharashtra, PVC/PE/PVDC blister Pin code: 410 220

Laurus Labs Limited, Laurus Labs Ltd, (Unit-2), 2nd Floor, Serene Plot No:19, 20 & 21, Chambers, Road No. Western Sector, APSEZ, Daclatasvir(dihydrochloride) 60 mg Tablet 7, Banjara Hills, A HP028 Atchutapuram India Bottle, HDPE 28x1, 500x1 Hyderabad, Mandal,Visakhapatnam- Telangana, 500 034, District, Andhra Pradesh, India 531011, India

Edition: Version 22, 14 July 2021 List of hepatitis drugs Astra Zeneca Pharmaceuticals LP, 4601 Highway 62 East, Mount Vernon, Indiana, 47620, USA Bristol-Myers Squibb Bristol-Myers Squibb EMEA/H/C/0037 (BMS), Contrada Fontana Daclatasvir (dihydrochloride) 90mg Tablet B USA Blister, Alu/PVC-ACLAR 14x2, 28x1 Company 68 del Ceraso, Anagni- Frosinone, 3012, Italy Bristol-Myers Squibb Manufacturing Company, State Road #3, Km 77.5, Humacao, 00791, Puerto Rico Hetero labs Limited, Unit- HP005 V, Jadcherla, HDPE Bottle ; Blister 1 Entecavir 0.5 mg Tablet Hetero labs Limited A-B India 30, 90 ; 10, 10*10 ANDA 205740 Mahaboobnagar-509 301, pack Telangana State Hetero labs Limited, Unit- HP006 V, Jadcherla, HDPE Bottle ; Blister 1 Entecavir 1.0 mg Tablet Hetero labs Limited A-B India 30, 90 ; 10, 10*8 ANDA 205740 Mahaboobnagar-509 301, pack Telangana State F- 4 & F-12, MIDC, Tablet, Malegaon, Mylan Laboratories Ledipasvir+ sofosbuvir 90 mg+ 400 mg Film- A HP019 Sinnar, Nashik - 422 113 India HDPE Bottle 28 Limited coated Maharashtra

F- 4 & F-12, MIDC, Tablet, Malegaon, Mylan Laboratories Sofosbuvir/Velpatasvir 400mg+100mg Film- A HP026 Sinnar, Nashik - 422 113 India HDPE Bottle 28 Limited coated Maharashtra

IDA Business & Technology Park, Carrigtohill, County Tablet, Gilead Sciences Cork, Ireland Sofosbuvir/Velpatasvir 400mg+100mg Film- A HP024 Canada Bottle, HDPE 28x1 Ireland UC Patheon Inc, 2100 Syntex coated Court, Mississauga, Ontario, L5N 7K9

F4 & F12 Malegaon MIDC, Mylan Laboratories Sinnar, Nashik District, HDPE Bottle -White or Sofosbuvir 400 mg Tablet A HP001 India 28 Ltd Maharashtra, 422 113, Blue India Cipla, Unit 2, Plot A-42 MIDC Industrial Area, Blister, Alu- Sofosbuvir 400 mg Tablet Cipla Ltd A HP004 Patalganga, Raigad District, India PVC/PE/PVdC 14x2; 28x1;84x1 Maharashtra, 410 220, Bottle,HDPE India Hetero labs Limited, Unit- V, Jadcherla, Sofosbuvir 400 mg Tablet Hetero labs Limited A HP002 India HDPE Bottle 28 Mahaboobnagar-509 301, Telangana State

Edition: Version 22, 14 July 2021 List of hepatitis drugs Oral Solid Dosage Forms Division, KRS Gardens, Strides Pharma 36/7, Suragajakkanahalli, Sofosbuvir 400 mg Tablet A HP009 India HDPE Bottle 28 Science Limited Indlawadi Cross, Anekal Taluk, Bangalore, Karnataka, 562 106 Plot No. A-42 (Unit II), MIDC, Patalganga, District - Tablet Co- Daclatasvir+Sofosbuvir 60 mg+ 400 mg Cipla Ltd A HP023 Raigad, India Al/PVC/PE/PVDC blister 7' blister Maharashtra, Pin code: 410 220 F- 4 & F-12, MIDC, Tablet, Malegaon, Mylan Laboratories Daclatasvir+Sofosbuvir 60 mg+ 400 mg Film- A HP025 Sinnar, Nashik - 422 113 India HDPE Bottle 28 Limited coated Maharashtra

Edition: Version 22, 14 July 2021 List of hepatitis drugs List Of Antihepatitis Pharmaceutical Products (included to support Global Fund Policy for Co-Infections and Co-Morbidities)

Edition: Version 22 - 14 July 2021 List of ERP ( Expert Review Panel) Reviewed Products which are permitted for time limited procurement

Global International Non- Strength/ Dosage Supplier/ Period Validity Ref. Fund QA Manufacturing site Country Material Pack proprietary name Dose form Manufacturer(s) for ERP Review No Standard

End of ERP Reviewed products list

Edition: Version 22, 14 July 2021 List of hepatitis drugs