Product Details
WHO Product ID
BT-ON014
Status
Prequalified
INN, dosage form and strength
Water for Injection Solvent for parenteral use + Trastuzumab Powder for concentrate for solution for infusion 20mL + 420mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Oncology
Type
Biotherapeutic Product
Dosage form
Solvent for parenteral use + Powder for concentrate for solution for infusion
Applicant organization
Biocon Biologics Limited
16 Great Queen Street, Covent Garden
London,
WC2B 5AH
United Kingdom
Packaging details and storage conditions
Packaging Type
50-mL type I glass vials - 20 mL type I glass vial
Configuration
1x1
Shelf life (months)
36
Storage conditions
Store in a refrigerator (2 °C to 8 °C)
API Manufacturing Site(s)
By Organization
By Active Ingredient
Biocon Biologics India Limited
Special Economic Zone, Plot Nos. 2, 3, 4 & 5 - Phase-IV, Bommasandra-Jigani Link Road, Bommasandra Post
Bangalore,
560 099
India
Trastuzumab
Charles River Laboratories, Inc. (Bulk harvest testing)
358 Technology Drive
Malvern,
19355
United States of America
Trastuzumab
FPP Manufacturing Site(s)
Biocon Biologics India Limited
Special Economic Zone, Plot Nos. 2, 3, 4 & 5 - Phase-IV, Bommasandra-Jigani Link Road, Bommasandra Post
Bangalore,
560 099
India