Product details
WHO Product ID
WHOAPI-423
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Reproductive health
Grade
Standard
INN
Carbetocin
Confirmation of WHO API prequalification document (version date)
Applicant organization
Piramal Pharma Limited
C-43 Off Thane Belapur Road MIDC, TTC Industrial Area Turbhe
Navi Mumbai, Thane,
Maharashtra
400703
India
APIMF Version Number
HPPL/AP/CB/06/18-01-2021
HPPL/AP/CB/06/18-01-2021/Amend-01/Nov-2022
HPPL/RP/CB/03/18-01-2021
HPPL/AP/CB/06/18-01-2021/Amend-01/Nov-2022
HPPL/RP/CB/03/18-01-2021
Product Grades
API specification number
CIC/QC/CB/01(01) Rev No. 03
Storage condition
Store in a refrigerator (2 °C to 8 °C), protect from moisture, protect from ligh
Storage period (months)
36
Duration type
Retest period
Packaging
Primary packaging: White HDPE containers equipped with inner cap and PP screw cap.
Secondary packaging: Aluminium bag with silica pouch.
Secondary packaging: Aluminium bag with silica pouch.
API Manufacturing Site(s)
Piramal Pharma Limited
C-43 Off Thane Belapur Road MIDC, TTC Industrial Area Turbhe
Navi Mumbai, Thane,
Maharashtra
400703
India