Medicines/finished pharmaceutical products

Reference Number: 
HA630

Date of prequalification: 
15 August 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Valganciclovir (hydrochloride)
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 450mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Blister, Alu/Alu 10x1; Bottle HDPE 60x1
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: 

(Valganciclovir (hydrochloride)) Hetero Drugs Limited, Unit 9, Plot 1, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India

API WHO Public Inspection Reports: