Product details
WHO Product ID
WHOAPI-406
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Grade
Standard
INN
Flucytosine
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
Flucytosine/OP/00/Dec-2019
Flucytosine/OP/00/Dec-2019/Amend 01-April-2021
Flucytosine/OP/00/Dec-2019/Amend 02-Feb-2022
Flucytosine/RP/00/Dec-2019
Flucytosine/OP/00/Dec-2019/Amend 01-April-2021
Flucytosine/OP/00/Dec-2019/Amend 02-Feb-2022
Flucytosine/RP/00/Dec-2019
Product Grades
API specification number
SPEC-AM-QC-104, R2
Storage condition
Do not store above 25°C, protect from moisture, protect from light
Storage period (months)
48
Duration type
Retest period
Packaging
Primary packaging: Clear, transparent low density polythene bag tightly closed with pilfer proof tag kept in an aluminium bag (triple laminated).
Secondary packaging: HDPE drums.
Secondary packaging: HDPE drums.
API Manufacturing Site(s)
Solara Active Pharma Sciences Limited
Plot No. N39/N-39-1, Addl. MIDC, Anand Nagar,
Ambernath (East), District Thane,
Maharashtra
421 506
India