Product details
WHO Product ID
WHOAPI-177
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Grade
Standard
INN
Cycloserine
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
CLN/WHO/AP-CTD/04/2020
CLN/WHO/RP-CTD/04/2020
CLN/WHO/AP-CTD/04/2020/Amend 01-Jan-2023
CLN/WHO/RP-CTD/04/2020/Amend 01-Jan-2023
CLN/WHO/RP-CTD/04/2020
CLN/WHO/AP-CTD/04/2020/Amend 01-Jan-2023
CLN/WHO/RP-CTD/04/2020/Amend 01-Jan-2023
Product Grades
API specification number
SPEC-A2-QC-018; Revision: R3
Storage condition
Store in a refrigerator (2 °C to 8 °C), protect from moisture, protect from ligh
Storage period (months)
24
Duration type
Shelf life
Packaging
Translucent polyethylene bag purged with nitrogen and closed with pilfer proof seal. The translucent polyethylene bag is covered with aluminium foil bag (triple laminated bag), a silica gel sachet is kept in between two bags, purged with nitrogen and heat sealed. The bags are placed in a metal drum, silica gel is placed in between metal drum and aluminium foil bag (triple laminated bag)
API Manufacturing Site(s)
Solara Active Pharma Sciences Limited
A-1/B, Sipcot Industrial Complex, Kudikadu Village, Tamil Nadu
Cuddalore,
607 005
India