Product Details
WHO Product ID
HP012
Status
Prequalified
INN, dosage form and strength
Daclatasvir (dihydrochloride) Tablet, Film-coated 60mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Hepatitis B and C
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Hetero Labs Ltd
Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Ranga Reddy District
Hyderabad,
Telangana
500 018
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
28x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from moisture, protect from light
Packaging Type
Blister, Alu/PVC/Aclar
Configuration
10x10
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from moisture, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Hetero Labs Ltd
Unit 1, Survey No 10 IDA, Gaddapothoram Village, Jinnaram (M), Sangareddy District
Telangana
502319
India
Daclatasvir (dihydrochloride)
FPP Manufacturing Site(s)
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