Medicines/finished pharmaceutical products

Reference Number: 
HA306

Date of prequalification: 
23 May 2006
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 (Bottle HDPE), 24 (Blister)
Packaging: 
Bottle HDPE: 30x1; Blister Alu/PVC/PE/PVdC: 10x3
Applicant: 
Sun Pharmaceutical Industries Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himanchal Pradesh, 173 025, India
FPP Manufacturing Site: 

Sun Pharmaceutical Industries Limited, Village Ganguwala, Paonta Sahib, District Sirmour, Himanchal Pradesh, 173 025, India

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Efavirenz) Mylan Laboratories Ltd, Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District, Andhra Pradesh, 535 204, India
(Efavirenz) Laurus Labs Ltd, Plot No 21, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, India