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HA770

Product Details
WHO Product ID
HA770
Status
Prequalified
INN, dosage form and strength
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/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
Cipla Ltd
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel
Mumbai,
Maharashtra
400 013
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1, 90x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, avoid excursions 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
Efavirenz
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Lamivudine, Tenofovir disoproxil fumarate
FPP Manufacturing Site(s)
Cipla Quality Chemical Industries Ltd
PO Box 34871, Plot No 1-7 Ring Road, Luzira Industrial Park
Kampala,
Uganda
Cipla
Unit 2, Plot A-42 MIDC, Patalganga, Raigad District
Maharashtra
410 220
India

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