KYOWA PHARMA CHEMICAL CO LTD

Overview

KYOWA PHARMA CHEMICAL CO LTD is an active pharmaceutical ingredient (API) supplier with 6 active FDA Type II Drug Master Files, covering BIMATOPROST DRUG SUBSTANCE; DINOPROSTONE (IEDA) DRUG SUBSTANCE; DINOPROSTONE DRUG SUBSTANCE; LATANOPROST; OLOPATADINE HYDROCHLORIDE DRUG SUBSTANCE; TRANEXAMIC ACID DRUG SUBSTANCE.

API / Drug Master Files

KYOWA PHARMA CHEMICAL CO LTD holds 6 active (7 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• DINOPROSTONE (IEDA) DRUG SUBSTANCEActive2025-03-31
• LATANOPROSTActive2018-08-07
• OLOPATADINE HYDROCHLORIDE DRUG SUBSTANCEActive2014-06-16
• TRANEXAMIC ACID DRUG SUBSTANCEActive2012-06-05
• BIMATOPROST DRUG SUBSTANCEActive2008-06-10
• DINOPROSTONE DRUG SUBSTANCEActive1994-12-27
• GP531T DRUG SUBSTANCEInactive2009-05-29

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to KYOWA PHARMA CHEMICAL CO LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.