Kissei Pharmaceutical Co., Ltd.

Matsumoto, Japan

Overview

Kissei Pharmaceutical Co., Ltd. is a Japanese pharmaceutical company focused on the research, development, and commercialization of treatments for various diseases. The company is known for its strong pipeline in urology, nephrology, and diabetes care.

Therapeutic areas

UrologyNephrologyDiabetesGastroenterologyOncology

API / Drug Master Files

Kissei Pharmaceutical Co., Ltd. holds 2 active (4 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.

  • LINZAGOLIX CHOLINEActive2021-06-03
  • KMD-3213 (SILODOSIN) DRUG SUBSTANCEActive1998-06-18
  • KLH-2109 CHOLINE DRUG SUBSTANCEInactive2016-01-12
  • KAD-1229Inactive1998-01-30

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Kissei Pharmaceutical Co., Ltd. in our records. PharmaTek screens the full directory against live FDA enforcement data.

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