Product details
WHO Product ID
WHOAPI-335
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Hepatitis B and C
Grade
Standard
INN
Daclatasvir (dihydrochloride)
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/Daclatasvir Dihydrochloride/OP/02/September-2021
LL/Daclatasvir Dihydrochloride/RP/02/September-2021
LL/Daclatasvir Dihydrochloride/RP/02/September-2021
Product Grades
API specification number
FS/ADCTR/02, Version no. 2.0
Storage condition
Do not store above 30°C, protect from moisture, protect from light
Storage period (months)
60
Duration type
Shelf life
Packaging
Transparent Low Density Poly Ethylene (LDPE) bag with strip seal followed by black Low Density Polyethylene bag with strip seal. Finally the LDPE is kept 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