Chang Kuo Chou Pharmaceutical Co., Ltd.

Overview

Chang Kuo Chou Pharmaceutical Co., Ltd. is a Taiwanese pharmaceutical company specializing in the manufacture of drugs and medicines, particularly known for its product 'Stomachin' used to treat gastrointestinal issues. Established nearly a century ago, the company has become a household name in Taiwan for digestive health remedies.

Therapeutic areas

API / Drug Master Files

Chang Kuo Chou Pharmaceutical Co., Ltd. holds 3 active (5 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.

  • PROPAFENONE HYDROCHLORIDEActive2023-02-09
  • TETRACAINE HYDROCHLORIDEActive2008-12-31
  • TETRACAINEActive2008-12-31
  • FELODIPINEInactive2011-10-18
  • AMLODIPINE BESYLATE (NON-STERILE DRUG SUBSTANCE)Inactive2008-01-16

FDA compliance signals

1 FDA enforcement record linked to this company.

  • 4832017-09-08

    SOPs not followed / documented

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