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BEST QUALITY AND SERVICE

Pharmaceutical rubber components that contribute to build aw better world

Regulatory Support

  • FDA Drug Master File

    • Samsung Medical Rubber Co.,Ltd. has deposited a type III DMF c/o FDA in 2008 DMF No. 21539.
    • The DMF contains all relevant info for Drug Application in USA, it is regularly maintained to include all new developments.
  • Regulatory Support

    • We provide a wide range of Technical Documents, Certificates and Compliance Statement to assist our customers.
    • Our products are in compliance with all the major Worldwide Pharmacopoeias, namely : KP, EP, USP, JP
    • Our standard formulations are tested for extractables by Toxikon Europe.