Medicines/finished pharmaceutical products

Reference Number: 
HA562

Date of prequalification: 
17 November 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, protect from moisture, protect from light
Shelf life (months): 
24
Packaging: 
Bottle HDPE: 30x1; 90x1; 180x1
Applicant: 
Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India
FPP Manufacturing Site: 

Macleods Pharmaceuticals Ltd, Block No. N2, Village Theda, P.O. Lodhi Majra, Tehsil Baddi, District Solan, Himachal Pradesh, 174 101, India
Macleods Pharmaceuticals Ltd, Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, 396 210, India

API Manufacturing Site: 

(Efavirenz) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Efavirenz) Hetero Drugs Limited, Unit 9, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, 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) Acebright (India) Pharma Pvt Ltd, 77D & 116/117 KIADB Industrial Area, Jigani, Bangalore, Karnataka, 560 105, 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
(Tenofovir disoproxil fumarate) Mangalam Drugs and Organics Ltd, Unit 1, Plot No 187, 2nd Phase GIDC, Vapi, Gujarat, 396 195, India
(Tenofovir disoproxil fumarate) Laurus Labs Ltd, Plot No 21, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, India
(Emtricitabine) Hetero Labs Ltd, Unit 1, Survey No 10 IDA, Gaddapothoram Village, Kazipally, Jinnaram (M), Sangareddy District, Telangana, 502319, India
(Emtricitabine) Hetero Drugs Limited, Unit 9, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Emtricitabine) Shijiazhuang Lonzeal Pharmaceuticals Co Ltd, Workshop No.101 and 302, 16 West Ring Road, Shenze, Shijiazhuang, Hebei, 052560, China (People's Republic of)
(Emtricitabine) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Emtricitabine) Macleods Pharmaceuticals Ltd, Plot No 2209 GIDC Industrial Area, At and Post Sarigam, Taluka: Umbergaon, Valsad District, Gujarat, 396 155, India
(Tenofovir disoproxil fumarate) Macleods Pharmaceuticals Ltd, Plot No 2209 GIDC Industrial Area, At and Post Sarigam, Taluka: Umbergaon, Valsad District, Gujarat, 396 155, India
(Emtricitabine) Laurus Labs Ltd, Plot No 21, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, India
(Efavirenz) Laurus Labs Ltd, Plot No 21, Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam District, Andhra Pradesh, 531 021, India