WHO Product ID
HA790
Status
Prequalified
INN, dosage form and strength
Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60mg/5mg/30mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
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
30x1, 60x1, 90x1, 120x1, 180x1; with or without dosing cup
Shelf life (months)
24
API Manufacturing Site(s)
By Organization
By Active Ingredient
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India
Abacavir (sulfate)
Lupin Manufacturing Solutions Ltd.
Plot No. 130, Road No. 11, J.N. Pharma City, Parawada (M), Anakapalli District
Andhra Pradesh
531019
India
Dolutegravir (sodium)
Shanghai Desano Chemical Pharmaceutical Co., Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Lamivudine
FPP Manufacturing Site(s)
Lupin Limited
Unit 1, Plot No. 6A1, 6A2, Sector-17, Special Economic Zone, MIHAN
Nagpur,
Maharashtra
441 108
India