Product details
WHO Product ID
WHOAPI-377
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Abacavir (sulfate)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Jiangsu Weiqida Pharmaceutical Co Ltd
No. 1 Linjiang Avenue, Linjiang Town, Haimen District
Nantong,
Jiangsu
226133
China
APIMF Version Number
Jiangsu Weiqida/Abacavir Sulfate/OP/V. 3.0/Date 2022-11-22 Jiangsu Weiqida/Abacavir Sulfate/RP/V. 3.0/Date 2022-11-22
Product Grades
API specification number
HM-STP-QA-001-02-08 version 01
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Primary pack: The API is packed into two layers of drug-using grade plastic bags of LDPE; each layer of the LDPE plastic bag is fastened tight with plastic ties. Secondary pack: The plastic package is put into a cardboard drum. And then, seal cardboard drum tightly and affix corresponding labels.
API Manufacturing Site(s)
Jiangsu Weiqida Pharmaceutical Co Ltd
No. 1 Linjiang Avenue, Linjiang Town, Haimen District
Nantong,
Jiangsu
226133
China