Medicines/finished pharmaceutical products

Reference Number: 
HA389 *

Date of prequalification: 
24 February 2009
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Efavirenz
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 200mg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
36
Packaging: 
Bottle HDPE: 90x1
Applicant: 
Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India
FPP Manufacturing Site: 

Strides Pharma Science Limited, Oral Solid Dosage Forms Division, KRS Gardens, 36/7, Suragajakkanahalli, Indlawadi Cross, Anekal Taluk, Bangalore, Karnataka, 562 106, India

API Manufacturing Site: 

(Efavirenz) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Efavirenz) Zhejiang Jiangbei Pharmaceutical Co Ltd, Zhang’an Street, Dongdai Village, Taizhou, Jiaojiang, Zhejiang, 318 017, China (People's Republic of)
(Efavirenz) Laurus Labs Ltd, Plot No 21, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, India
(Efavirenz) Mylan Laboratories Ltd, Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District, Andhra Pradesh, 535 204, India