Medicines/finished pharmaceutical products

Reference Number: 
HA352 *

Date of prequalification: 
16 December 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
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla Ltd, Unit 1, PO Bhud, Upper Malpur Village, Tehsil, Nalagarh, Solan District, Himanchal Pradesh, 173 205, India
Meditab Specialities Pvt Ltd, 352 Kundaim Industrial Estate, Kundaim, Goa, 403 115, India
Cipla Ltd, Unit 3, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette, Goa, 403 722, India
Cipla Ltd, Unit 4, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette, Goa, 403 722, India
Cipla Ltd, Unit 7, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette, Goa, 403 722, India
Cipla Quality Chemical Industries Ltd, PO Box 34871, Plot No 1-7 Ring Road, Luzira Industrial Park, Kampala, Uganda

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) Laurus Labs Ltd, Plot No 21, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, India