Product Details
WHO Product ID
HA631
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
Micro Labs Limited
31 Race Course Road
Bangalore,
Karnataka
560 001
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, 100x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
Packaging Type
Blister, Alu/Alu
Configuration
10x3, 10x10
Shelf life (months)
36
Storage conditions
Do not store above 30°C
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
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 3, Plot No 18, Jawaharlal Nehru Pharma City, Parawada
Anakapalli,
Andhra Pradesh
531 021
India
Emtricitabine
Mangalam Drugs and Organics Limited
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
Emtricitabine, Tenofovir disoproxil fumarate
FPP Manufacturing Site(s)
Micro Labs Limited
Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate
Verna,
Goa
403 722
India