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.

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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 any drug master file filed with the FDA with respect to a Product, and any equivalent filing in other countries or regulatory jurisdictions.

Examples of Drug Master File in a sentence

• Corium shall provide such information (or right of reference thereto such as a right of reference to a Drug Master File) as required by law or as necessary to obtain regulatory approval for the manufacture of the Product to (i) Agile or (ii) the applicable regulatory agency, at Agile’s election.

• Furthermore, [ * ] will authorise the United States Food and Drug Administration ("FDA") and any other regulatory agency around the world to review the Drug Master File in support of the Product registration applications.

• If SGI has a Drug Master File (DMF) with the FDA or equivalent that contains information useful to support an IND or application for Regulatory Approval, SGI shall so notify Genmab and allow Genmab the right of reference to the contents of such DMF.

• Emisphere shall manufacture the Carrier in conformance with the Specifications and the Drug Master File and in a manner which fully complies with such statutes, ordinances, regulations and practices.

• Licensee agrees that the Drug Master File ("DMF") shall be owned by NovaDel, provided that Licensee shall have unlimited access to the DMF for purposes of any Regulatory Filings relating to each Licensed Product.

More Definitions of Drug Master File

Drug Master File means a voluntary submission to the FDA that may be used to provide confidential, detailed information about any aspect of the Manufacturing of any Licensed Compound or Licensed Product (including the facilities used therefor).

Drug Master File or “DMF’ means a submission to the FDA by ASL that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of the Active Ingredient.

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

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 or “DMF” as used in Section 4.3, means the drug master file (as such term is defined in 21 C.F.R. Part 314.420) that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of drug products intended for human use.

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