Product details
WHO Product ID
WHOAPI-163
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
Ipca Laboratories Ltd
48 Kandivli Industrial Estate, Kandivli (West)
Mumbai,
Maharashtra
400 067
India
APIMF Version Number
Ipca/Artemether/AR14/DMF/AP/02/2021-04-19
Ipca/Artemether/AR14/DMF/RP/02/2021-04-19
Ipca/Artemether/AR14/DMF/AP/02/2021-04-19/Amend-01 January 2023
Ipca/Artemether/AR14/DMF/RP/02/2021-04-19/Amend-01 January 2023
Ipca/Artemether/AR14/DMF/RP/02/2021-04-19
Ipca/Artemether/AR14/DMF/AP/02/2021-04-19/Amend-01 January 2023
Ipca/Artemether/AR14/DMF/RP/02/2021-04-19/Amend-01 January 2023
Product Grades
API specification number
TS/API/AR11/DMF, Version Number 4.0
Storage condition
Do not store above 25°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Inner bag: Clear LDPE bag (Nitrogen purging); Middle bag: Black LDPE bag; desiccant placed between the inner and the middle bag; Outer bag: PET/Aluminium/Pet/Poly Bag in either Fibre Drums or HMHDPE drums
API Manufacturing Site(s)
Ipca Laboratories Ltd
Sejavta, Ratlam
Madhya Pradesh
457 001
India