Product details
WHO Product ID
WHOAPI-447
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Conversion
Therapeutic area
Tuberculosis
Type
None
Grade
Standard
INN
Rifapentine
Confirmation of WHO API prequalification document (version date)
Applicant organization
Lupin Ltd.
Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East)
Mumbai,
Maharashtra
400 055
India
APIMF Version Number
LL/Rifapentine /AP/00/2021-09-30
LL/Rifapentine /RP/00/2021-09-30
Amendment 01 – April 2024
LL/Rifapentine /RP/00/2021-09-30
Amendment 01 – April 2024
Product Grades
API specification number
API 321932 TRP SRGD_004071 (5.0)
Storage condition
Store in a refrigerator (2°C to 8°C), protect from moisture, protect from light
Storage period (months)
24
Duration type
Retest period
Packaging
Primary: Nylon semi-transparent pouch.
Secondary: Black low-density polyethylene bag inserted in aluminium laminated bag.
Tertiary: HDPE container.
Secondary: Black low-density polyethylene bag inserted in aluminium laminated bag.
Tertiary: HDPE container.
API Manufacturing Site(s)
Lupin Ltd
T-142, M.I.D.C, Thane District
Tarapur, Via Boisar,
Maharashtra
401 506
India