Medicines/finished pharmaceutical products

Reference Number: 
HA053 *

Date of prequalification: 
20 March 2002
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Lamivudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Solution, Oral 50mg/5mL
Storage condition: 
Do not store above 25°C, protect from light
Shelf life (months): 
24
Packaging: 
Bottle PET Brown: 100x1
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla Ltd, Unit I, Plot No 9, 10 & 15 Indore Special Economic Zone, Phase II, Pithampur, Dhar District, Madhya Pradesh, 454 775, India

API Manufacturing Site: 

(Lamivudine) Shijiazhuang Lonzeal Pharmaceuticals Co Ltd, Workshop No.101 and 302, 16 West Ring Road, Shenze, Shijiazhuang, Hebei, 052560, China (People's Republic of)
(Lamivudine) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Sangareddy District, Telangana, 502 319, India
(Lamivudine) Cipla Ltd, Plot D-22 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District, Maharashtra, 413 802, India
(Lamivudine) Hetero Labs Ltd, Unit 9, Plot 2 Hetero Infrastructure Ltd - SEZ, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Lamivudine) Cipla Ltd, Unit 1, Plot A-33 & A-2 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India
(Lamivudine) Cipla Ltd, Plot D-7 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District, Maharashtra, 413 802, India
(Lamivudine) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)