Product details
WHO Product ID
WHOAPI-361
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Reproductive health
Type
None
Grade
Standard
INN
Oxytocin
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
OP-03-2021-09-29
RP-03-2021-09-29
OP-03-2021-09-29/Amend-01/July-2022
RP-03-2021-09-29/Amend-01/July-2022
OP-03-2021-09-29/Amend-02/Dec-2023
RP-03-2021-09-29/Amend-02/Dec-2023
RP-03-2021-09-29
OP-03-2021-09-29/Amend-01/July-2022
RP-03-2021-09-29/Amend-01/July-2022
OP-03-2021-09-29/Amend-02/Dec-2023
RP-03-2021-09-29/Amend-02/Dec-2023
Product Grades
API specification number
CIC/QC/O/01; Rev No. 2.0
Storage condition
Store in a refrigerator (2 °C to 8 °C), protect from moisture
Storage period (months)
36
Duration type
Shelf life
Packaging
Light resistant, high density polyethylene (HDPE) round bottle
API Manufacturing Site(s)
Piramal Pharma Limited
C-43 Off Thane Belapur Road MIDC, TTC Industrial Area Turbhe
Navi Mumbai, Thane,
Maharashtra
400703
India