Drug Master File definition

Drug Master File or “DMF” is described in 21 C.F.R. Part 314.420. A DMF is a submission to the 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.

Drug Master File means any drug master file filed with the FDA with respect to any Licensed Product or any intermediate thereof, and any equivalent filing in other countries or regulatory jurisdictions.

Drug Master File or “DMF” shall mean a drug master file filed with the FDA or the EMEA which includes information relating to the facilities, processes, or articles used in manufacturing, processing, packaging, and storing of the API, or any equivalent filing in any jurisdiction outside the United States or Europe.

Examples of Drug Master File in a sentence

• The main objective of the ASMF procedure, commonly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or ‘know-how’ of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the applicant or marketing authorisation holder (MAH) to take full responsibility for the medicinal product, the quality and quality control of the active substance.

• The R&D efforts streamlined by effective project management coupled with dedicated Pilot Plant facilities across Active Pharmaceutical Ingredients (APIs) and formulation plants have seen ramping up of the output from R&D resulting in an increased number of Drug Master File (DMF), Dossier and Abbreviated New Drug Applications (ANDAs) filings in regulated markets.

• In addition, include a retrospective review of the analytical data and batch records for all of the APIs distributed that remain within expiration, along with an evaluation of data that may have been generated to support a drug application, including any Drug Master File.

• Drug Master File: A drug master file (DMF) is a master file that provides a full set of data on an API.Excipient: Any component of a finished dosage form which has no therapeutic value.

More Definitions of Drug Master File

Drug Master File means a submission to the FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of a pharmaceutical product.

Drug Master File or “DMF” means a drug master file document containing detailed information about the manufacturing of the Product the active pharmaceutical ingredient of the Product packaging, and/or excipient, colorant, flavour, essence, or material including information describing the manufacturing site, the manufacturing facility, the operating procedures, the personnel, the manufacture, chemistry and control of the drug substance and the drug substance intermediates.

Drug Master File means a Drug Master File filed with the FDA as described in 21 C.F.R. §314.420.

Drug Master File means any (a) drug master files filed with the FDA with respect to the Product, (b) active substance master file (ASMF) filed with the EMA, and (c) equivalent filing in other countries in the Licensee Territory.

Drug Master File means a Drug Master File, as defined in the U.S. Federal Food, Drug, and Cosmetic Act, pursuant to 21 C.F.R. § 314.420 as amended, and the regulations promulgated thereunder (or the equivalent thereto as specified in any succeeding legislation), or any foreign equivalent thereto, with respect to the manufacture of any Subject Product or an Inspire Licensed Product.

Drug Master File or “DMF” means any drug master file filed with the FDA or the equivalent filed with any other Governmental Authority with respect to a Licensed Compound or Product or any component or intermediate thereof.

Drug Master File means a drug master file maintained by the PDA with respect to a prospective product for which Regulatory Approval is sought;