Dossiers

CDSCO

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

USFDA

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, an Export Application, or amendments and supplements to any of these.

EDQM

 

FWQRC facilitates for the preparation of dossiers for the following types of DMF

WHO

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel

 

  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

ISO

  • Type III Packaging MaterialANVISA-logo-BE63621131-seeklogo.com

 

  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

TGA_logo

MHRA

  • Type V FDA Accepted Reference Information

HPRACOFEPRIS                            CFDA

FWQRC assists to file the DMF through eCTD

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