WHO Product ID
BT-DX001
Status
Prequalified
INN, dosage form and strength
Mtb-specific antigen rCFP-10/Mtb-specific antigen rdESAT-6 Solution for injection 0.5 mcg per mL/0.5 mcg per mL
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
1st Invitation for Mycobacterium tuberculosis antigen-based skin tests (TBSTs)
Type
Biotherapeutic Product
Dosage form
Solution for injection
Applicant organization
Serum Institute of India Pvt. Ltd.
212/2 Off Soli Poonawala Road, Hadaspar
Pune,
Maharashtra
411 028
India
Packaging details and storage conditions
Packaging Type
Vial, type I glass
Configuration
1 mL vial x 1, 1 mL vial x 10
Shelf life (months)
24
API Manufacturing Site(s)
By Organization
By Active Ingredient
Serum Institute of India Pvt. Ltd.
212/2 Off Soli Poonawala Road, Hadaspar
Pune,
Maharashtra
411 028
India
Mtb-specific antigen rCFP-10, Mtb-specific antigen rdESAT-6
FPP Manufacturing Site(s)
Serum Institute of India Pvt. Ltd.
212/2 Off Soli Poonawala Road, Hadaspar
Pune,
Maharashtra
411 028
India