Product details
WHO Product ID
WHOAPI-357
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Darunavir
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/Darunavir/OP/01/December-2019
LL/Darunavir/RP/01/December-2019
LL/Darunavir/RP/01/December-2019
Product Grades
API specification number
FS/ADVR/03 version 0.0
Storage condition
Store in a refrigerator (2 °C to 8 °C), protect from moisture
Storage period (months)
18
Duration type
Retest period
Packaging
The API is packed in transparent double polythene bags (LDPE), both nitrogen purged & tied with a strip seal. The second LDPE bag is containing dessicant silica gel.
API Manufacturing Site(s)
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India