Medicines/finished pharmaceutical products

Reference Number: 
HA538 *

Date of prequalification: 
19 February 2014
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 600mg/200mg/300mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Bottle HDPE: 30x1, 500x1, 28x1
Applicant: 
Hetero Labs Ltd, Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District, Telangana, 509 301, India
FPP Manufacturing Site: 

Hetero Labs Ltd, Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District, Telangana, 509 301, India

API Manufacturing Site: 

(Tenofovir disoproxil fumarate) Hetero Labs Ltd, Unit 9, Plot 2 Hetero Infrastructure Ltd - SEZ, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Efavirenz) Hetero Labs Ltd, Unit 9, Plot 2 Hetero Infrastructure Ltd - SEZ, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Efavirenz) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Emtricitabine) Hetero Labs Ltd, Unit 9, Plot 2 Hetero Infrastructure Ltd - SEZ, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Emtricitabine) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Tenofovir disoproxil fumarate) Acebright (India) Pharma Pvt Ltd, 77D & 116/117 KIADB Industrial Area, Jigani, Bangalore, Karnataka, 560 105, India
(Efavirenz) Hetero Labs Ltd, Unit 9, Plot 2 Hetero Infrastructure Ltd - SEZ, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Efavirenz) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Sangareddy District, Telangana, 502319, India
(Emtricitabine) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Sangareddy District, Telangana, 502319, India
(Tenofovir disoproxil fumarate) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Sangareddy District, Telangana, 502319, India

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