WHO Product ID
TB408
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
Mylan Laboratories Ltd.
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
10x10, 6x4
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Store in original container. Avoid excursions above 30°C
Packaging Type
Bottle, HDPE
Configuration
188x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C. Store in original container. Avoid excursions above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Matrix Pharmacorp Private Limited
Unit 8, Gaitula Chodavaram, Poosapatirega Mandal, Vizianagaram
Andhra Pradesh
535 204
India
Bedaquiline (fumarate)
FPP Manufacturing Site(s)
Mylan Laboratories Ltd
Plot No H-12 & H13 MIDC Waluj Industrial Area
Chhatrapati Sambhajinagar,
Maharashtra
431 136
India