Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF. However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Typically, a drug master file is filed when two or more firms work in partnership on developing or manufacturing a drug product. The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details.
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. 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.
A DMF is NOT a substitute for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. Technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application.
This guideline does not impose mandatory requirements (21 CFR 10.90(b)). It does, however, offer guidance on acceptable approaches to meeting regulatory requirements. Different approaches may be followed, but the applicant is encouraged to discuss significant variations in advance with FDA reviewers to preclude spending time and effort in preparing a submission that FDA may later determine to be unacceptable.
Drug Master Files are provided for in 21 CFR 314.420. This guideline is intended to provide DMF holders with procedures acceptable to the agency for preparing and submitting a DMF. The guideline discusses types of DMF's, the information needed in each type, the format of submissions to a DMF, the administrative procedures governing review of DMF's, and the obligations of the DMF holder.
DMF's are generally created to allow a party other than the holder of the DMF to reference material without disclosing to that party the contents of the file. When an applicant references its own material, the applicant should reference the information contained in its own IND, NDA, or ANDA directly rather than establishing a new DMF.
CPPL is having great experiance in DMF Writting and is also authorised agend for US DMF submission and till now we have submitted more than 400 DMF to fidderent authorities of the world
Many Small scale Manufacturers are confused with Dossier compilation and dossier writting,writting dossier is a technical skill and it involves study and review of technical documents of Client and compilation is just a document formating skill which can be handled by any non techincal person.CPPL assures complete compliance of regulatory norms with its strong technical staff and knowledge gained throughout their industrial experiance
In your all kind of regulatory compilations,creation of documents and submission Cyclone Pharmaceuticals Pvt Ltd,the Pharmaceutical Consultants of India will help at every stage.Unlike other consultants we have team with QA,QC ,Production and Regulatory sector so review of documents ,compilation of dossiers and Query answering is ultimately easiest task for CPPL
Regulatory consultancy services of Cyclone Pharmaceuticals are proven services with highest Quality and Lowest cost.Our compiled documents many times are being accepted by regulatory authorities without single query. CPPL team is always alert for new updations in regulations provides perfect Drug Dossier,DMF,CTD,ACTD,KDMF,USDMF.eCTD,EUDMF,USDMF and other format compilation
Why to Choose CPPL as your Regulatory and Dossier Partner
Knowledge of Pharmaceutical Technologies
Knowledge about formulation and analytical techniques
Minimises time of registration with it's Perfect dossier service
Complete Support for Generating documents like PV,AMV,Stability
Comparativelly very Low Cost (Do not compaire with computor operators who provide Dossiers free of cost)
Honest servives ,we says yes if it is possible and no if having any difficulties
To serve Pharmaceutical Industry with best quality services and to bring a Quality culture in Documentation and regulatory services
Note : CPPL The best regulatory service providers of India do not compete with any other service providers because we know we are best