Medicines/finished pharmaceutical products

Reference Number: 
HA399 *

Date of prequalification: 
01 July 2009
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Efavirenz
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 600mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
30x1 bottle (36 months), 28x1 & 250x1 bottles (48 months)
Packaging: 
Bottle HDPE 30x1; Bottle HDPE 250x1; Bottle HDPE 28x1
Applicant: 
Hetero Labs Ltd, Unit III, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India
FPP Manufacturing Site: 

Hetero Labs Ltd, Unit III, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055, India
Hetero Labs Ltd, Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District, Telangana, 509 301, India

API Manufacturing Site: 

(Efavirenz) Zhejiang Jiangbei Pharmaceutical Co Ltd, Zhang’an Street, Dongdai Village, Taizhou, Jiaojiang, Zhejiang, 318 017, China (People's Republic of)
(Efavirenz) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Sangareddy District, Telangana, 502319, India