Product Details
WHO Product ID
HA551
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
Sun Pharmaceutical Industries Limited
Sun House, 201 B/1, Western Express Highway, Goregaon (East)
Mumbai,
400063
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
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
Emtricitabine, Tenofovir disoproxil fumarate
Sun Pharmaceutical Industries Limited
Village Toansa, P.O. Rail Majra, Dist. S.B.S. Nagar (Nawanshahar)
Punjab
144 533
India
Tenofovir disoproxil fumarate
FPP Manufacturing Site(s)
Sun Pharmaceutical Industries Limited
Village Ganguwala, District Sirmour
Paonta Sahib,
Himachal Pradesh
173 025
India