Product details
WHO Product ID
WHOAPI-240
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Grade
Sterile
INN
Artesunate (sterile)
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 Ph. Int. (Sterile) /AT2 / AP / 03/ 2022-08-08-August 2022
Ipca /Artesunate Ph. Int. (Sterile) /AT2 / RP / 03/ 2022-08-08-August 2022
Ipca/Artesunate Ph. Int. (Sterile)/AT2/AP/03/2022-08-08- Amend 01- June 2023
Ipca/Artesunate Ph. Int. (Sterile)/AT2/RP/03/2022-08-08 Amend 01- June 2023
Ipca /Artesunate Ph. Int. (Sterile) /AT2 / RP / 03/ 2022-08-08-August 2022
Ipca/Artesunate Ph. Int. (Sterile)/AT2/AP/03/2022-08-08- Amend 01- June 2023
Ipca/Artesunate Ph. Int. (Sterile)/AT2/RP/03/2022-08-08 Amend 01- June 2023
Product Grades
API specification number
TS/BPC/AT2/CS/DMF, issue No. 01, revision 07 (micronised)
Storage condition
Do not store above 25°C, protect from moisture, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Artesunate (Sterile) is packed in Aluminium Container with a rubber plug and with an aluminium cap and equipped with rope seal on each container. and then kept in corrugated box.
API Manufacturing Site(s)
Ipca Laboratories Ltd
Sejavta, Ratlam
Madhya Pradesh
457 001
India