Medicines/finished pharmaceutical products

Reference Number: 
HA553

Date of prequalification: 
12 December 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 25°C, protect from moisture
Shelf life (months): 
24
Packaging: 
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: 

(Emtricitabine) Mylan Laboratories Limited, Unit 2, Survey No. 10/42, Gaddapotharam, Kazipally Industrial Area, Medak District, Telangana, 502 319, India
(Efavirenz) 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
(Emtricitabine) 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 21, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, India
(Tenofovir disoproxil fumarate) Acebright (India) Pharma Pvt Ltd, 77D & 116/117 KIADB Industrial Area, Jigani, Bangalore, Karnataka, 560 105, India
(Efavirenz) Zhejiang Jiangbei Pharmaceutical Co Ltd, Zhang’an Street, Dongdai Village, Taizhou, Jiaojiang, Zhejiang, 318 017, China (People's Republic of)
(Emtricitabine) Mylan Laboratories Limited, Unit 2, Survey No. 10/42, Gaddapotharam, Kazipally Industrial Area, Medak District, Telangana, 502 319, India