Rajkiran Kolakota1 & N. Sireesha2*
1-2Department of Pharmaceutical Regulatory Affairs, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, AP.
A B S T R A C T
Drug Master File (DMF) is a document containing complete information on drugs and its related compounds i.e, Active Pharmaceutical Ingredient (API) or finished drug dosage form such as drug product’s chemistry, manufacture, stability, purity, impurity profile, packaging of any human drug product, and it is prepared by the pharmaceutical manufacturer and it is submitted completely with its context to the respected regulatory authority to support a third party application without disclosing the information. Generally a DMF is filed when two or more persons work in partnership or manufacturing a drug product. The DMF filing allows a firm to protect its intellectual property from its partner contexting with regulatory requirements for revealing of processing details. The pharmaceutical industry is one of the highly regulated and exciting industries worldwide with many rules and regulations enacted by government to protect the public health and well being. So without regulatory approval by the team of medical researchers and other specialists; no drug is marketed. A drug master file comprises two parts: the Applicant’s Part (Open Part), which contains all the accessible information, related to administration that the DMF holder needs to assess the quality and submit an amendment application; and the Restricted Part (Closed Part), which contains confidential information about the manufacturing procedure that only needs to be disclosed to the authorities. In USFDA, refer as Drug Master File and in Canada, referred as Master File (MF) respectively. 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 a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), Biological License Application another DMF, or amendments and supplements to any of these.
Keywords: New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biological License Application, Drug Master File. etc.