Product details
WHO Product ID
WHOAPI-081
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Type
None
Grade
Standard
INN
Artesunate
Confirmation of WHO API prequalification document (version date)
Applicant organization
Ipca Laboratories Ltd
48 Kandivli Industrial Estate, Kandivli (West)
Mumbai,
Maharashtra
400 067
India
APIMF Version Number
Ipca/Artesunate/AS6/DMF/AP/02/2021-01-28
Ipca/Artesunate/AS6/DMF/RP/02/2021-01-28
Ipca/Artesunate/AS6/DMF/AP/02/2021-01-28-Amend 01-October 2024
Ipca/Artesunate/AS6/DMF/RP/02/2021-01-28-Amend 01-October 2024
Ipca/Artesunate/AS6/DMF/RP/02/2021-01-28
Ipca/Artesunate/AS6/DMF/AP/02/2021-01-28-Amend 01-October 2024
Ipca/Artesunate/AS6/DMF/RP/02/2021-01-28-Amend 01-October 2024
Product Grades
API specification number
TS/API/AS6/DMF Rev No. 03
Storage condition
Do not store above 25°C
Storage period (months)
36
Duration type
Retest period
Packaging
Inner bag: clear LDPE with nitrogen purging; Middle: black LDPE bag with silica gel; Outer: Aluminium/Pet/Poly bagSecondary: fibre drums
API Manufacturing Site(s)
Ipca Laboratories Ltd
Sejavta, Ratlam
Madhya Pradesh
457 001
India