Product details
WHO Product ID
WHOAPI-311
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Hepatitis B and C
Grade
Standard
INN
Sofosbuvir
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/WHO/Sofosbuvir/OP/001/December, 2019
Solara/WHO/Sofosbuvir/RP/001/December, 2019
Solara/WHO/Sofosbuvir/RP/001/December, 2019
Product Grades
API specification number
BAT/FP/R10
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
36
Duration type
Retest period
Packaging
Double HM-HDPE Bags (inner white, outer black) as primary packing material and HDPE containers as secondary packing material.
API Manufacturing Site(s)
Solara Active Pharma Sciences Ltd
120 A & B, 36, 120P & 121 Industrial Area, Baikampady
New Mangalore,
Karnataka
575 011
India