Product details
WHO Product ID
WHOAPI-125
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Standard
INN
Artemether
Confirmation of WHO API prequalification document (version date)
Applicant organization
KPC Pharmaceuticals Inc
No 166 Keyi Road, High and New Technology Development Zone
Kunming,
Yunnan
650 106
China
APIMF Version Number
KPCAPIMF_ART_OP_08
KPCAPIMF_ART_RP_08
KPCAPIMF_ART_RP_08
Product Grades
API specification number
Q1-08003-07
Storage condition
Store in a refrigerator (2 °C to 8 °C)
Storage period (months)
36
Duration type
Retest period
Packaging
Twin polyethylene bags placed in steel drums
API Manufacturing Site(s)
KPC Pharmaceuticals Inc
Small Volume Injection Plant, Qigongli (W)
Kunming,
Yunnan
650 100
China