List Of Antihepatitis Pharmaceutical Products (included to support Global Fund Policy for Co-Infections and Co-Morbidities)
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1 Edition: Version 11-19th of July 2018 List of A & B Products List Of Antihepatitis Pharmaceutical Products (included to support Global Fund Policy for Co-Infections and Co-Morbidities) 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 Ref. No International Nonproprietary name Strength/ Dose Dosage form Supplier/ Manufacturer(s) Global Fund QA Standard WHO Prequalificatio n/ SRA Manufacturing site Country Material Pack 18 Daclatasvir 30mg Tablet BMS Pharma UK A-B Yes, na Batch release:bms Italy Blister 28 (2x14's)
2 Daclatasvir (dihydrochloride) 30mg Tablet A-B HP007 Vernon, na, 47620, Manufacturing, Daclatasvir (dihydrochloride) 60mg Tablet A-B HP008 Vernon, na, 47620, Manufacturing, 19 Daclatasvir 60mg Tablet BMS Pharma UK A-B Yes, na Batch release:bms Italy Blister 28 (2x14's) Daclatasvir (dihydrochloride) 90mg Tablet B EMEA/H/C/ Vernon, na, 47620, Manufacturing, 1 Entecavir 0.5 mg Tablet Hetero labs Limited A-B HP005 ANDA HDPE Bottle ; Blister pack 30, 90 ; 10, 10*10
3 1 Entecavir 1.0 mg Tablet Hetero labs Limited A-B HP006 ANDA HDPE Bottle ; Blister pack 30, 90 ; 10, 10*8 Sofosbuvir 400 mg Tablet Ltd A HP001 F4 & F12 Malegaon MIDC, Sinnar, Nashik District, Maharashtra, , HDPE Bottle -White or Blue 28 Sofosbuvir 400 mg Tablet Cipla Ltd A HP004 Sofosbuvir 400 mg Tablet Hetero labs Limited A HP002 Cipla, Unit 2, Plot A- 42 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, , Blister, Alu- PVC/PE/PVdC Bottle,HDPE 14x2; 28x1;84x1 HDPE Bottle 28
4 Edition: Version 11-19th of July 2018 List Of Antihepatitis Pharmaceutical Products (included to support Global Fund Policy for Co-Infections and Co-Morbidities) List of ( Expert Review Panel) Products which are permitted for time limited procurement Ref. No International Nonproprietary name Strength/ Dose Dosage form Supplier/ Manufacturer(s) Global Fund QA Standard Period Validity for Review Manufacturing site Country Material Pack Sofosbuvir 400 mg Tablet European Egyptian Pharm. Ind Cairo Desert Road KM.25, El Manshia Alex, Amriya, Alexandria, Egypt Egypt HDPE Bottle 28 Sofosbuvir 400 mg Tablet Strides Shasun Ltd Strides Shasun ltd- 36/7, Suragajakkanahalli Indlavadi Cross, Anekal Taluk Bangalore HDPE Bottle 28 Daclatasvir 30 mg Tablet Limited F- 4 & F-12, MIDC, Malegaon, Sinnar, Nashik Maharashtra 28; 10x1 Daclatasvir 30 mg Tablet Cipla Ltd Plot No. A-42 (Unit II), MIDC, Patalganga, District - Raigad, Maharashtra, Pin code: ; 14x2 Edition: Version 11, 19th of July-2018 List of hepatitis drugs
5 Daclatasvir 30 mg Tablet Hetero Lab Ltd Unit- V, TSIIC Formulation SEZ, Sy No. 439, 440, 441 & 458, Polepally Village, Jadcherla Mandal, Mahaboobnagar District, Telangana HDPE Bottle 28 Daclatasvir 60 mg Tablet Limited F- 4 & F-12, MIDC, Malegaon, Sinnar, Nashik Maharashtra 28; 10x1 Daclatasvir 60 mg Tablet Cipla Ltd Plot No. A-42 (Unit II), MIDC, Patalganga, District - Raigad, Maharashtra, Pin code: ; 14x2 Daclatasvir 60 mg Tablet Hetero Lab Ltd Hetero Labs Limited Unit- V, TSIIC Formulation SEZ, Sy No. 439, 440, 441 & 458, Polepally Village, Jadcherla Mandal, Mahaboobnagar District, Telangana HDPE Bottle 28 Ledipasvir+ sofosbuvir 90 mg+ 400 mg Tablet FDC Cipla Ltd KRS Gardens Tablet Block 36/7, Suragajakkanahalli, Indlavadi cross, Anekal Taluk Bangalore HDPE Bottle 14 s, 15 s, 30 s or 28 s End of products list Edition: Version 11, 19th of July-2018 List of hepatitis drugs
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