Product details
WHO Product ID
WHOAPI-491b
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Type
None
Grade
Micronized
INN
Bedaquiline fumarate
Confirmation of WHO API prequalification document (version date)
Applicant organization
Matrix Pharmacorp Private Limited
Plot No. 14, 99 and 100, IDA Pashamylaram Phase-II
Patancheru, Sangareddy District,
Telangana
502307
India
APIMF Version Number
MPPL/BEF/AP/001/01/Nov-2025
MPPL/BEF/RP/001/01/Nov-2025
MPPL/BEF/RP/001/01/Nov-2025
Product Grades
API specification number
STP/FPR/BEF/007/01
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
12
Duration type
Retest period
Packaging
White PE bag (twisted and tied with plastic fastener), then inserted in white PE bag (and heat-sealed). Both these bags are then put into the outer bag of triple laminated aluminium bag (and heat-sealed) and placed in HDPE drums.
API Manufacturing Site(s)
Matrix Pharmacorp Private Limited
Unit 8, Gaitula Chodavaram, Poosapatirega Mandal, Vizianagaram
Andhra Pradesh
535 204
India