Product Details
WHO Product ID
BT-ON017
Status
Prequalified
INN, dosage form and strength
Benzyl alcohol/Water for Injection Solvent for parenteral use+Trastuzumab Powder for concentrate for solution for infusion 1.1%/20mL+440mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Oncology
Type
Biotherapeutic Product
Dosage form
Powder for concentrate for solution for infusion + Solvent for parenteral use
Applicant organization
Biosimilar Collaborations Ireland Limited
Unit 35/36 Grange Parade, Baldoyle Industrial Estate
Dublin,
D13 R20R
Ireland
Packaging details and storage conditions
Packaging Type
Vial, clear glass type I
Configuration
one 20mL vial bacteriostatic water for injection
Shelf life (months)
48
Packaging Type
Vial, Clear glass type I
Configuration
One 50mL vial
Shelf life (months)
48
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
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
Charles River Laboratories, Inc. (Bulk harvest testing)
358 Technology Drive
Malvern,
19355
United States of America