Sumitomo Dainippon Pharma Co., Ltd.

Osaka, Japan

Overview

Sumitomo Dainippon Pharma Co., Ltd. is a leading pharmaceutical company based in Japan, specializing in innovative research and development of treatments across various therapeutic areas. It operates as a public company with a global footprint, providing solutions to enhance human health and well-being.

Therapeutic areas

NeuroscienceOncologyInfectious DiseasesCardiovascularDiabetes

API / Drug Master Files

Sumitomo Dainippon Pharma Co., Ltd. holds 0 active (6 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.

  • RANIRESTAT (AS-3201)Inactive2008-03-19
  • DROXIDOPAInactive2007-05-23
  • SM-5887 (AMRUBICIN HYDROCHLORIDE)Inactive2005-11-30
  • SMP-986Inactive2005-04-13
  • MEROPENEM BULK BLENDInactive2005-02-16
  • MEROPENEMInactive1993-06-25

FDA compliance signals

4 FDA enforcement records linked to this company.

  • 4832025-07-11

    Procedures for sterile drug products

  • 4832025-07-11

    Computer control of master formula records

  • 4832025-07-11

    Validation lacking for sterile drug products

  • 4832025-07-11

    Cleaning System

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