Medicines/finished pharmaceutical products

Reference Number: 
HA410 *

Date of prequalification: 
27 October 2009
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 light
Shelf life (months): 
36
Packaging: 
Bottle HDPE: 30x1, 100x1; Blister Alu/Alu: 10x2
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

API Manufacturing Site: 

(Tenofovir disoproxil fumarate) Mylan Laboratories Limited (Unit-10), Plot No. 86, Ramky Pharma City (India) Ltd, JN Pharma City, Parawada Mandal, Visakhapatnam, Andhra Pradesh, 531019, India
(Tenofovir disoproxil fumarate) Laurus Labs Ltd, Plot No 18, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, India
(Tenofovir disoproxil fumarate) Laurus Labs Ltd, Plot No 21, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, 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