Product details
WHO Product ID
WHOAPI-028
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Type
None
Grade
Standard
INN
Rifampicin
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/RIFAMPIN/AP/04/2007-05-28
LL/RIFAMPIN/RP/04/2007-05-28
Amendment 01 - June 2022
Amendment 01 - February 2023
Amendment 02 - July 2023
Amendment 01 – March 2024
LL/RIFAMPIN/RP/04/2007-05-28
Amendment 01 - June 2022
Amendment 01 - February 2023
Amendment 02 - July 2023
Amendment 01 – March 2024
Product Grades
API specification number
API 318304 (TRP_SRGD_002890 (3.0))
Storage condition
Do not store above 25°C, protect from moisture, protect from light
Storage period (months)
12
Duration type
Retest period
Packaging
Material is packed under nitrogen in inner transparent polythene bag (LDPE) tied and twisted with cable tie and inserted in another Nylon bag. O-buster oxygen absorber (Scavenger) bag and silica gel is inserted between inner polythene bag (LDPE) and outer Nylon bag, flush with Nitrogen followed by heat sealing. It is then further placed in the outer triple laminated aluminium (TLAB) bag. This pack is heat sealed and kept in HM HDPE containers.
API Manufacturing Site(s)
Lupin Ltd
T-142, M.I.D.C, Thane District
Tarapur, Via Boisar,
Maharashtra
401 506
India