Medicines/finished pharmaceutical products

Reference Number: 
HA403 *

Date of prequalification: 
25 July 2008
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
Packaging: 
Bottle HDPE: 30x1; Blister Alu/PVC/PVdC: 5x2
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India
FPP Manufacturing Site: 

Mylan Laboratories Ltd, Plot No H-12 & H13 MIDC Waluj Industrial Area, Aurangabad, Maharashtra, 431 136, India
Mylan Laboratories Ltd, Plot No 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase II, Sector III, Pithampur, District Dhar, Madya Pradesh, 454 775, India
Mylan Laboratories Ltd, F4 & F12 Malegaon MIDC, Sinnar, Nashik District, Maharashtra, 422 113, India
Questa Care Limited, Plot No. 209/7184, P.O Box 172-00623, Homabay Road Terminus, Gate No.19, Industrial Area, Kenya

API Manufacturing Site: 

(Efavirenz) Mylan Laboratories Limited (Unit-10), Plot No. 86, Ramky Pharma City (India) Ltd, JN Pharma City, Parawada Mandal, Visakhapatnam, Andhra Pradesh, 531019, India
(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