Medicines/finished pharmaceutical products

Reference Number: 
HP005 (a)

Date of prequalification: 
28 November 2017
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Entecavir
Therapeutic area: 
Hepatitis
Dosage form & strength: 
Tablet, Film-coated 0.5mg
Storage condition: 
Do not store above 25°C
Shelf life (months): 
24
Packaging: 
Bottle, HDPE 30x1, 90x1
Applicant: 
Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India
FPP Manufacturing Site: 

Hetero Labs Ltd, Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District, Telangana, 509 301, India

API Manufacturing Site: 

(Entecavir) Hetero Drugs Ltd, Unit 1, Survey No 213, 214 & 255, Bonthapally Village, Jinnaram Mandal,Medak District, Telangana, India

API WHO Public Inspection Reports: