Daiichi Sankyo Co., Ltd.

Overview

Daiichi Sankyo Co., Ltd. is a leading global pharmaceutical company headquartered in Tokyo, Japan. It focuses on the research, development, and marketing of pharmaceutical products, particularly in the field of cardiovascular diseases, oncology, and vaccines.

Therapeutic areas

API / Drug Master Files

Daiichi Sankyo Co., Ltd. holds 3 active (32 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.

  • MAAA-1162A (COMMERCIAL)Active2019-07-31
  • MAAA-1162AActive2015-12-09
  • SUN11031 (HUMAN GHRELIN) DRUG SUBSTANCEActive2005-06-30
  • DS-1594B DRUG SUBSTANCEInactive2020-11-20
  • DS-1594B DRUG PRODUCTInactive2020-11-20
  • SUN13837 DRUG SUBSTANCEInactive2009-01-09
  • SUN13834 DRUG SUBSTANCEInactive2006-08-09
  • BENICAR HCTR (OLMESARTAN MEDOXOMIL HYDROCHLOROTHIAZIDE) TABLETSInactive2006-07-25
  • DZ-697B DRUG SUBSTANCEInactive2005-10-24
  • BENICAR(TM) TABLETS 5 MG, 20 MG AND 40 MGInactive2004-09-14
  • DW-908E DRUG SUBSTANCEInactive2004-07-06
  • CS-088 DRUG SUBSTANCEInactive2004-06-14
  • CS-023 DRUG SUBSTANCEInactive2004-03-12
  • DU-176B DRUG SUBSTANCEInactive2004-02-13
  • DX-619 DRUG SUBSTANCEInactive2003-07-28

Showing 15 of 32 Drug Master Files.

FDA compliance signals

4 FDA enforcement records linked to this company.

  • 4832025-08-01

    Failure to comply with REMS Implementation System

  • 4832025-08-01

    Failure to comply with REMS Elements to Assure Safe Use (ETASU) A

  • 4832023-12-22

    Absence of Written Procedures

  • 4832023-12-22

    Investigations of discrepancies, failures

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