DMF FILING IN US, EUROPE AND CANADA

  • Pooja Agarwal
  • J. K. Badjatya

Abstract

A Drug Master File or DMF is a reference source that provides drug evaluator’s confidential information not available to drug product manufacturer about the specific process and components used in the manufacturing, processing and packaging of a drug meant for Human/Animal use. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, or amendments and supplements to any of these.

Keywords: DMF, ICH CTD, AP. RP, FDA, QOS, CMC.

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References

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How to Cite
Agarwal, P., and J. K. Badjatya. “DMF FILING IN US, EUROPE AND CANADA”. International Journal of Drug Regulatory Affairs, Vol. 3, no. 4, Feb. 2018, pp. 9-17, doi:10.22270/ijdra.v3i4.172.

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