Viewing data from:

TRANEXAMIC ACID

ANDA

TRANEXAMIC ACID | A219123 | BIONPHARMA INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain9 active DMFs3 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

HUNAN DONGTING PHARMACEUTICAL CO LTDTRANEXAMIC ACID

DMF 141811999

ALP PHARM BEIJING CO LTDTRANEXAMIC ACID

DMF 222772008

ASAHI KASEI FINECHEM CO LTDTRANEXAMIC ACID USP

DMF 253312011

KYOWA PHARMA CHEMICAL CO LTDTRANEXAMIC ACID DRUG SUBSTANCE

DMF 261282012

SHILPA PHARMA LIFESCIENCES LTDTRANEXAMIC ACID USP

DMF 330862018

AMI LIFESCIENCES PRIVATE LTDTRANEXAMIC ACID USP

DMF 363362021

MALLADI DRUGS AND PHARMACEUTICALS LTDTRANEXAMIC ACID

DMF 371302022

KP MANISH GLOBAL INGREDIENTS PVT LTDTRANEXAMIC ACID USP

DMF 398252024

ZHEJIANG BAMBOO PHARMACEUTICALS CO LTDTRANEXAMIC ACID

DMF 414072025

DAIICHI SANKYO CO LTDInactiveTRANEXAMIC ACID

DMF 38641980

PHARMACIA AND UPJOHNInactiveTRANEXAMIC ACID

DMF 48561983

CMIC CMO CO LTDInactiveTRANEXAMIC ACID

DMF 94181991

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 650MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 19, 2025

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

BIONPHARMA's TRANEXAMIC ACID (tranexamic acid) NDA 219123 transitioned from prescription (RX) to discontinued (DISCN) status.

Old: RX

New: DISCN

MODIFIEDTE Code7/1/2026

BioPharma's tranexamic acid product (NDA 219123) therapeutic equivalence code changed from AB to an unspecified new value.

Old: AB