Product details
WHO Product ID
WHOAPI-233
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Type
None
Grade
Standard
INN
Dihydroartemisinin
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/Artenimolum (Artenimol) Ph.Int./DK4/AP/03/2021-05-11
Ipca/Artenimolum (Artenimol) Ph.Int./DK4/RP/03/2021-05-11
Ipca/Artenimolum (Artenimol) Ph.Int./DK4/AP/03/2021-05-11-Amend 01-December 2023
Ipca/Artenimolum (Artenimol) Ph.Int./DK4/RP/03/2021-05-11-Amend 01-December 2023
Ipca/Artenimolum (Artenimol) Ph.Int./DK4/RP/03/2021-05-11
Ipca/Artenimolum (Artenimol) Ph.Int./DK4/AP/03/2021-05-11-Amend 01-December 2023
Ipca/Artenimolum (Artenimol) Ph.Int./DK4/RP/03/2021-05-11-Amend 01-December 2023
Product Grades
API specification number
TS/BPC/DK4/CS/DMF, Issue No. 01, Rev. No. 08
Storage condition
Store in a refrigerator (2 °C to 8 °C), protect from moisture, protect from ligh
Storage period (months)
36
Duration type
Retest period
Packaging
Inner: clear LDPE bag; Middle: black LDPE bag; and Outer: PET/Aluminium/PET bag
API Manufacturing Site(s)
Ipca Laboratories Ltd
Sejavta, Ratlam
Madhya Pradesh
457 002
India