Product details
WHO Product ID
WHOAPI-113b
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Grade
Compacted
INN
Rifampicin
Confirmation of WHO API prequalification document (version date)
Applicant organization
Olon S.p.A.
Strada Rivoltana, km 6/7
Rodano,
Milan
20090
Italy
APIMF Version Number
Sandoz Private Limited/Rifampicin/WHO/AP/08 May 2017
Sandoz Private Limited/Rifampicin/WHO/RP/08 May 2017
Sandoz Private Limited/Rifampicin/WHO/RP/09/Jan2019
Sandoz Private Limited/Rifampicin/WHO/AP/09/Jan2019
Amendment 10 – April 2019
Amendment 11 – August 2020
Version 1.4 – September 2019 edition with August 2021 update
Sandoz Private Limited/Rifampicin/WHO/RP/08 May 2017
Sandoz Private Limited/Rifampicin/WHO/RP/09/Jan2019
Sandoz Private Limited/Rifampicin/WHO/AP/09/Jan2019
Amendment 10 – April 2019
Amendment 11 – August 2020
Version 1.4 – September 2019 edition with August 2021 update
Product Grades
API specification number
Compacted - SRF/M/QC/321, v02
Storage condition
Do not store above 25°C, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
LDPE (Low Density Poly Ethylene) bag with a plastic strip seal in secondary LDPE bag tight with a plastic strip seal. 3 desiccant pouches and 3 oxygen absorbers are placed in between the two LDPE bags. The bags are then placed in aluminium-polyethylene bag with 3 desiccant pouches and 3 oxygen absorbers and heat sealed with nitrogen purging. This is further placed in sealed HMHDPE drum.
API Manufacturing Site(s)
Olon Active Pharmaceutical Ingredients India Private Limited
Plot No: L-1, L-21 to L-28 & L-44, Additional Phase MIDC, Raigad District
Mahad,
Maharashtra
402 301
India