药品/药物成品

Reference Number: 
HA631

Date of prequalification: 
27 May 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Emtricitabine/Tenofovir disoproxil fumarate
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 200mg/300mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Blister Alu/Alu 10x1; Bottle HDPE 30x1, 100x1
Applicant: 
Micro Labs Ltd, 27 Race Course Road, Bangalore, Karnataka, 560 001, India
FPP Manufacturing Site: 

Micro Labs Ltd, Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate, Verna, Goa, 403 722, India

API Manufacturing Site: 

(Tenofovir disoproxil fumarate) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India
(Tenofovir disoproxil fumarate) Mangalam Drugs and Organics Limited, Unit-2, G.I.D.C, 3rd Phase, Plot no. 1203, Vapi, Valsad, Gujarat, 396 195, India
(Emtricitabine) Laurus Labs Ltd, Plot No 18, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, India
(Emtricitabine) Mangalam Drugs and Organics Limited, Unit-2, G.I.D.C, 3rd Phase, Plot no. 1203, Vapi, Valsad, Gujarat, 396 195, India
(Emtricitabine) Laurus Labs Ltd, Plot No 21, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, India
(Tenofovir disoproxil fumarate) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Sangareddy District, Telangana, 502319, India
(Tenofovir disoproxil fumarate) Hetero Drugs Limited, Unit 9, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India