Product details
WHO Product ID
WHOAPI-097b
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Malaria
Type
None
Grade
Micronised
INN
Artesunate
Confirmation of WHO API prequalification document (version date)
Applicant organization
Solara Active Pharma Sciences Limited
6th floor, No.5, Ticel Bio Park Module No 601, 602 and 603 CSIR Road, Tharamani
Chennai,
Tamil Nadu
600 113
India
APIMF Version Number
Solara/APIMF/Artesunate/OP/001/March, 2020 Amendment-2, November 2025
Solara/APIMF/Artesunate/RP/001/March, 2020 Amendment-2, November 2025
Solara/APIMF/Artesunate/RP/001/March, 2020 Amendment-2, November 2025
Product Grades
API specification number
1400000037/FP/R6 (micronised)
Storage condition
Store in a refrigerator (2 °C to 8 °C)
Storage period (months)
48
Duration type
Retest period
Packaging
Food grade white HM HDPE bags followed by black HM HDPE bags in HDPE drums
API Manufacturing Site(s)
Solara Active Pharma Sciences Ltd
120 A & B, 36, 120P & 121 Industrial Area, Baikampady
New Mangalore,
Karnataka
575 011
India