Product Details
WHO Product ID
HA737
Status
Prequalified
INN, dosage form and strength
Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Lupin Ltd.
Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East)
Mumbai,
Maharashtra
400 055
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
Bottle, HDPE 30x1 and 60x1 (with 2 molecular sieve sachets), 90x1 (with 3 molecular sieve sachets)
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Store in the original package in order to protect from
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
Lamivudine
Laurus Labs Limited
Unit-4, Plot No.25, 25A to 25K, APSEZ De-Notified Area, Lalamkoduru Village, Rambilli Mandal
Anakapalli,
Andhra Pradesh
531011
India
Lamivudine
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India
Dolutegravir (sodium), Tenofovir disoproxil fumarate
Laurus Labs Limited
Unit 3, Plot No 18, Jawaharlal Nehru Pharma City, Parawada
Anakapalli,
Andhra Pradesh
531 021
India
Lamivudine, Tenofovir disoproxil fumarate
Lupin Manufacturing Solutions Ltd
Plot No. 130, Road No. 11, J.N. Pharma City, Parawada (M), Anakapalli
Andhra Pradesh
531019
India
Dolutegravir (sodium)
FPP Manufacturing Site(s)
Lupin Limited
Unit 1, Plot No. 6A1, 6A2, Sector-17, Special Economic Zone, MIHAN
Nagpur,
Maharashtra
441 108
India
Lupin Ltd
EPIP, SIDCO Industrial Complex, Kartholi
Bari Brahmana,
Jammu and Kashmir
181 133
India