Medicines/finished pharmaceutical products

Reference Number: 
HA679

Date of prequalification: 
12 December 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Tenofovir disoproxil fumarate
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 300mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Bottle,HDPE 30x1,500x1
Applicant: 
Laurus Labs Limited, 2nd Floor, Serene Chambers, Road 7, Banjara Hills, Hyderabad, Telangana, 500 034, India
FPP Manufacturing Site: 

Laurus Labs Ltd, (Unit-2), Plot No:19, 20 & 21, Western Sector, APSEZ, Atchutapuram Mandal,Visakhapatnam-District, Andhra Pradesh, 531011, India

API Manufacturing Site: 

(Tenofovir disoproxil fumarate) Laurus Labs Ltd, Plot No 21, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, India
(Tenofovir disoproxil fumarate) Laurus Labs Ltd, Plot No 18, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, India