WHO Product ID
TB395
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
MSN Laboratories Private Limited
“MSN House”, Plot No: C – 24, Industrial Estate, Sanath Nagar,
Hyderabad,
Telangana
500 018
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Shelf life (months)
48
Storage conditions
Do not store above 30°C
Packaging Type
Bottle, HDPE
Shelf life (months)
48
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
MSN Life Sciences Private Limited
Unit II, Sy.No. Parts of 454, 455, 457, 458 & 459 Chandampet (Village), Shankarampet-R (Mandal), Medak District
Telangana
502 255
India
Bedaquiline fumarate
FPP Manufacturing Site(s)
MSN Laboratories Private Limited
Formulations Division, Unit-II, Survey Nos. 1277, 1319 to 1324, Nandigama (Village & Mandal), Rangareddy (District)
Telangana
509228
India
