Product Details
WHO Product ID
HA561
Status
Prequalified
INN, dosage form and strength
Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/OPA/Alu/PVC
Configuration
10x10
Shelf life (months)
24
Storage conditions
Do not store above 25°C, store in dry condition, protect from light
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, store in dry condition, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Cdymax (India) Pharma Private Limited
77D & 116/117, KIADB Industrial Area, Jigani 2nd Phase, Bangalore
Bangalore,
Karnataka
560 105
India
Tenofovir disoproxil fumarate
Hetero Labs Limited
Unit IX, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Anakapalli District
Andhra Pradesh
531 081
India
Emtricitabine, Tenofovir disoproxil fumarate
Hetero Labs Ltd
Unit 1, Survey No 10 IDA, Gaddapothoram Village, Jinnaram (M), Sangareddy District
Telangana
502319
India
Tenofovir disoproxil fumarate
Laurus Labs Limited
Unit-4, Plot No.25, 25A to 25K, APSEZ De-Notified Area, Lalamkoduru Village, Rambilli Mandal
Anakapalli,
Andhra Pradesh
531011
India
Tenofovir disoproxil fumarate
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India
Emtricitabine, Tenofovir disoproxil fumarate
Laurus Labs Limited
Unit 3, Plot No 18, Jawaharlal Nehru Pharma City, Parawada
Anakapalli,
Andhra Pradesh
531 021
India
Emtricitabine
Macleods Pharmaceuticals Ltd
Plot No 2209 GIDC Industrial Estate At and Post Sarigam, Taluka: Umbergaon Dist: Valsad
Gujarat
396 155
India
Emtricitabine, Tenofovir disoproxil fumarate
Mangalam Drugs & Organics Ltd
Unit 1, Plot No 187, GIDC
Vapi,
Gujarat
396 195
India
Tenofovir disoproxil fumarate
Mangalam Drugs and Organics Limited
Unit-2, G.I.D.C, Plot no. 1203
Vapi,
Gujarat
396 195
India
Tenofovir disoproxil fumarate
Shanghai Desano Chemical Pharmaceutical Co. Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Emtricitabine
Shijiazhuang Lonzeal Pharmaceuticals Co Ltd
Workshop No.303, 104, 101 and 102, No.16 West Ring Road, Shenze
Shijiazhuang,
Hebei
52560
China
Emtricitabine
FPP Manufacturing Site(s)
Macleods Pharmaceuticals Ltd
Block No. N2, Village Theda, P.O. Lodhi Majra, District Solan
Tehsil Baddi,
Himachal Pradesh
174 101
India
Macleods Pharmaceuticals Ltd
Unit 2, Phase II, III and IV, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam
Daman,
396 210
India