Product Details
WHO Product ID
TB396
Status
Prequalified
INN, dosage form and strength
Bedaquiline fumarate Tablet 100mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Lupin Ltd.
Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East)
Mumbai,
Maharashtra
400 055
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
12x8, 12x11, 14x4
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Store in the original container or package in order to
Packaging Type
Strip, Alu/Alu
Configuration
10x10, 14x4
Shelf life (months)
30
Storage conditions
Do not store above 30°C. Store in the original container or package in order to
Packaging Type
Bottle, HDPE
Configuration
24x1, 188x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Store in the original container or package in order to
API Manufacturing Site(s)
By Organization
By Active Ingredient
Lupin Manufacturing Solutions Ltd
Plot No. 130, Road No. 11, J.N. Pharma City, Parawada (M), Anakapalli
Andhra Pradesh
531019
India
Bedaquiline fumarate
FPP Manufacturing Site(s)
Lupin Ltd
A-28/1 MIDC Industrial Area, Chikalthana
Aurangabad,
431 210
India