Product details
WHO Product ID
WHOAPI-319
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
Laurus Labs Limited
2nd Floor, Serene Chambers, Road No. 7, Banjara Hills
Hyderabad,
Telangana
500 034
India
APIMF Version Number
LL/Sofosbuvir/OP/01/October-2018
LL/Sofosbuvir/RP/01/October-2018
LL/Sofosbuvir/RP/01/October-2018
Product Grades
API specification number
FS/CSSV/01Version No: 2.0
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
36
Duration type
Retest period
Packaging
Double transparent Low Density Poly Ethylene (LDPE) bags (inner) and a triple laminated sunlight barrier (TLSB) (outer) in High Density Poly Ethylene (HDPE) container
API Manufacturing Site(s)
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India