Product details
WHO Product ID
WHOAPI-097a
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
Solara Active Pharma Sciences Limited
2nd Floor, Admin block 27 Vandaloor, Kelambakkram Road Keelakottaiyur Village, Melakottaiyur (Post)
Chennai,
Tamil Nadu
600 127
India
APIMF Version Number
Solara/APIMF/Artesunate/OP/001/March, 2020
Solara/APIMF/Artesunate/RP/001/March, 2020
Solara/APIMF/Artesunate/RP/001/March, 2020
Product Grades
API specification number
1400000050/FP/R4 (non-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