Product Details
WHO Product ID
HA740
Status
Prequalified
INN, dosage form and strength
Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Blister, Alu-OPA/Alu/PVC
Configuration
6x10
Shelf life (months)
60
Storage conditions
Do not store above 30°C, store in the original container
Packaging Type
Bottle, HDPE
Configuration
30x1
Shelf life (months)
60
Storage conditions
Do not store above 30°C, store in the original container
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
Hetero Labs Ltd
Unit 1, Survey No 10 IDA, Gaddapothoram Village, Jinnaram (M), Sangareddy District
Telangana
502319
India
Abacavir (sulfate), Lamivudine
FPP Manufacturing Site(s)
Macleods Pharmaceuticals Ltd
Block No. N2, Village Theda, P.O. Lodhi Majra, District Solan
Tehsil Baddi,
Himachal Pradesh
174 101
India