Medicines/finished pharmaceutical products

Reference Number: 
HA535 *

Date of prequalification: 
21 October 2013
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, protect from moisture
Shelf life (months): 
24
Packaging: 
Blister Alu/Alu: 10x1; Bottle HDPE: 30x1
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: 

(Tenofovir disoproxil fumarate) Acebright (India) Pharma Pvt Ltd, 77D & 116/117 KIADB Industrial Area, Jigani, Bangalore, Karnataka, 560 105, India
(Tenofovir disoproxil fumarate) Mylan Laboratories Ltd, Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District, Andhra Pradesh, 535 204, India
(Tenofovir disoproxil fumarate) Mylan Laboratories Ltd, Unit 1, Survey 10/42, Gaddapotharam, Kazipally Industrial Area, Sangareddy, Telangana, 502 319, India