Product details
WHO Product ID
WHOAPI-491a
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Type
None
Grade
Non-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/003/04
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
60
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