Medicines/finished pharmaceutical products

Reference Number: 
HA523

Date of prequalification: 
05 February 2013
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Lamivudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Solution, Oral 10mg/mL
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Bottle HDPE: 240ml Bottle HDPE: 100ml
Applicant: 
Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India
FPP Manufacturing Site: 

Macleods Pharmaceuticals Ltd, Block No. N2, Village Theda, P.O. Lodhi Majra, Tehsil Baddi, District Solan, Himachal Pradesh, 174 101, India

API Manufacturing Site: 

(Lamivudine) Laurus Labs Ltd, Plot No 18, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, India
(Lamivudine) Hetero Drugs Limited, Unit 9, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Lamivudine) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Sangareddy District, Telangana, 502319, India
(Lamivudine) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Lamivudine) Shijiazhuang Lonzeal Pharmaceuticals Co Ltd, Workshop No.101 and 302, 16 West Ring Road, Shenze, Shijiazhuang, Hebei, 052560, China (People's Republic of)