Product details
WHO Product ID
WHOAPI-442
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Type
None
Grade
Standard
INN
Bedaquiline fumarate
Confirmation of WHO API prequalification document (version date)
Applicant organization
Lupin Manufacturing Solutions Limited
3rd Floor, Kalpataru Inspire Off Western Express Highway, Santacruz (East)
Maharashtra
400055
India
APIMF Version Number
LUPIN LIMITED/ BEDAQUILINE FUMARATE/ AP/01/2021-11-30
LUPIN LIMITED/ BEDAQUILINE FUMARATE/ RP/01/2021-11-30
Amendment 01 – January 2024
LUPIN LIMITED/ BEDAQUILINE FUMARATE/ RP/01/2021-11-30
Amendment 01 – January 2024
Product Grades
API specification number
VZG_SRGD_005891 (2.0)
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
Transparent PE bag under nitrogen purging inserted into a black LDPE bag both these bags are put in an outer Aluminum foil laminated bag and placed in HM-HDPE drum.
API Manufacturing Site(s)
Lupin Manufacturing Solutions Ltd
Plot No. 130, Road No. 11, J.N. Pharma City, Parawada (M), Anakapalli
Andhra Pradesh
531019
India
Styrax Pharma Pvt Ltd
Plot No. 27B, Jawaharlal Nehru Pharma City, Parawada, Anakapalli
Andhra Pradesh
531021
India