Medicines/finished pharmaceutical products

Reference Number: 
HA323

Date of prequalification: 
07 March 2008
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Lamivudine/Nevirapine/Zidovudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 150mg/200mg/300mg
Storage condition: 
Do not store above 25°C, protect from moisture
Shelf life (months): 
36
Packaging: 
Bottle HDPE: 60x1; Blister Alu/PVC/PVdC: 10x6
Applicant: 
Sun Pharmaceutical Industries Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himanchal Pradesh, 173 025, India
FPP Manufacturing Site: 

Sun Pharmaceutical Industries Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himanchal Pradesh, 173 025, India

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Zidovudine) Mylan Laboratories Ltd, Unit 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Parawada (M), Visakhapatnam District, Andhra Pradesh, 531 021, India
(Zidovudine) Zhejiang Langhua Pharmaceutical Co Ltd, No 7, Donghai 3rd Avenue, Zhejiang Provincial Chemical & Medical Materials Base Linhai Zone, Linhai City, Zhejiang Province, 317 016, China (People's Republic of)
(Lamivudine) Hetero Drugs Limited, Unit 9, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Nevirapine) Zhejiang Huahai Pharmaceutical Co Ltd, Chuannan Site No.1 Branch Factory, Costal Industrial Zone, Duqiao, Linhai, Zhejiang, 317 016, China (People's Republic of)
(Lamivudine) Mylan Laboratories Ltd, Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District, Andhra Pradesh, 535 204, India
(Lamivudine) Mylan Laboratories Limited, Unit 2, Survey No. 10/42, Gaddapotharam, Kazipally Industrial Area, Medak District, Telangana, 502 319, India
(Lamivudine) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Nevirapine) Mylan Laboratories Ltd, Unit 1, Survey 10/42, Gaddapotharam, Kazipally Industrial Area, Sangareddy, Telangana, 502 319, India
(Nevirapine) Mylan Laboratories Limited, Unit 2, Survey No. 10/42, Gaddapotharam, Kazipally Industrial Area, Medak District, Telangana, 502 319, India
(Nevirapine) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Zidovudine) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Zidovudine) Mylan Laboratories Ltd, Unit 1, Survey 10/42, Gaddapotharam, Kazipally Industrial Area, Sangareddy, Telangana, 502 319, India