WHO Product ID
BT-ON014
Status
Prequalified
INN, dosage form and strength
Trastuzumab Powder for concentrate for solution for infusion 420mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Oncology
Type
Biotherapeutic Product
Dosage form
Powder for concentrate for solution for infusion
Applicant organization
Biocon Biologics Limited
16 Great Queen Street, Covent Garden
London,
WC2B 5AH
United Kingdom of Great Britain and Northern Ireland
Packaging details and storage conditions
Packaging Type
Vial, type I glass + Vial, type 1 glass
Configuration
420mg lyophilized powder (Trastuzumab) in 50mL vial + 20mL bacteriostatic water for injection in 20mL vial
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 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 Limited
Special Economic Zone, Plot Nos. 2, 3, 4 & 5 - Phase-IV, Bommasandra-Jigani Link Road, Bommasandra Post
Bangalore,
560 099
India