Product Details
WHO Product ID
HA459
Status
Prequalified
INN, dosage form and strength
Lamivudine/Zidovudine Tablet, Film-coated 150mg/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, PVC/PVdC/Alu
Configuration
10x6, 10x12
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from light
Packaging Type
Bottle, HDPE
Configuration
60x1
Shelf life (months)
48
Storage conditions
Do not store above 30°C, store in dry condition, protect from light
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, Zidovudine
Laurus Labs Limited
Unit 3, Plot No 18, Jawaharlal Nehru Pharma City, Parawada
Anakapalli,
Andhra Pradesh
531 021
India
Lamivudine
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Lamivudine, Zidovudine
Shijiazhuang Lonzeal Pharmaceuticals Co Ltd
Workshop No.303, 104, 101 and 102, No.16 West Ring Road, Shenze
Shijiazhuang,
Hebei
52560
China
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
Macleods Pharmaceuticals Ltd
Unit 2, Phase II, III and IV, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam
Daman,
396 210
India