Product details
WHO Product ID
WHOAPI-146
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Diarrhoea
Grade
Standard
INN
Zinc (sulfate)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Canton Laboratories Pvt Ltd
110 A & B GIDC, Makarpura
Vadodara,
Gujarat
390 010
India
APIMF Version Number
Canton/Zinc Sulfate MH USP/OP/04/Jul-2021
Canton/Zinc Sulfate MH USP/RP/04/Jul-2021
Canton/Zinc Sulfate MH USP/OP/04/Jul-2021/Amend 01 – Jan-2023
Canton/Zinc Sulfate MH USP/RP/04/Jul-2021/Amend 01 – Jan-2023
Canton/Zinc Sulfate MH USP/RP/04/Jul-2021
Canton/Zinc Sulfate MH USP/OP/04/Jul-2021/Amend 01 – Jan-2023
Canton/Zinc Sulfate MH USP/RP/04/Jul-2021/Amend 01 – Jan-2023
Product Grades
API specification number
QAS/CM/FPS/0076/PH version 003
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Retest period
Packaging
Double lined LDPE bags (a natural white transparent bag ) in a HDPE/Fiber/UN Drum and sealed.
API Manufacturing Site(s)
Canton Laboratories Pvt Ltd
Survey No. 350, Mujpur, Vadodara
Taluka: Padra,
Gujarat
391440
India