Product details
WHO Product ID
WHOAPI-443
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Reproductive health
Type
None
Grade
Standard
INN
Tranexamic acid
Confirmation of WHO API prequalification document (version date)
Applicant organization
Ami Lifesciences Private Limited
701 to 710, Lilleria 1038, Commercial Hub, Gotri Sevasi, 30Mtr Road, Next to Zydex Office,
Vadodara,
Gujarat
390021
India
APIMF Version Number
Tranexamic acid/OP/04/April-2024
Tranexamic acid/RP/04/April-2024
Tranexamic acid/RP/04/April-2024
Product Grades
API specification number
FPS/TAE/10/00, Rev.00
Storage condition
Do not store above 30°C
Storage period (months)
36
Duration type
Retest period
Packaging
Primary packaging: single white transparent LDPE bag.
Secondary packaging: black LDPE bag in HDPE drums.
Secondary packaging: black LDPE bag in HDPE drums.
API Manufacturing Site(s)
Ami Lifesciences Private Limited
Block No. 82/B ECP Road At & post-Karakhadi Karakhadi
Vadodara,
Gujarat
391450
India