Medicines/finished pharmaceutical products

Reference Number: 
HA633

Date of prequalification: 
24 October 2017
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): 
36 Months (Bottle), 24 Months (Blister)
Packaging: 
Blister Alu-PVC/PVdC 10x3; Bottle,HDPE 30x1
Applicant: 
Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India
FPP Manufacturing Site: 

Micro Labs Ltd, Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate, Verna, Goa, 403 722, India

API Manufacturing Site: 

(Efavirenz) Hetero Drugs Limited, Unit 9, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Efavirenz) Zhejiang Jiangbei Pharmaceutical Co Ltd, Zhang’an Street, Dongdai Village, Taizhou, Jiaojiang, Zhejiang, 318 017, China (People's Republic of)