Product Details
WHO Product ID
HA439
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
Cipla Ltd
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel
Mumbai,
Maharashtra
400 013
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Cipla Ltd
Plot D-22 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District
Maharashtra
413 802
India
Emtricitabine, Tenofovir disoproxil fumarate
Cipla Ltd
Plot D-27 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District
Maharashtra
413 802
India
Emtricitabine, Tenofovir disoproxil fumarate
Cipla Ltd
Plot D-7 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District
Maharashtra
413 802
India
Emtricitabine, 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
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
Tenofovir disoproxil fumarate
FPP Manufacturing Site(s)
Cipla Ltd
Unit 3, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette
Goa
403 722
India
Cipla Ltd
Unit 4, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette
Goa
403 722
India
Cipla Ltd
Unit 7, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette
Goa
403 722
India