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 a Product, 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

• Without limiting the foregoing, each Party shall have the right to cross reference, file or incorporate by reference any regulatory submission or Drug Master File (and any data contained therein) for the Product, or any component thereof (including any Regulatory Approvals), in order to support regulatory submissions that such Party has the right to make.

• Drug Master File DMF A Drug Master File is a document containing confidential information related to the manufacturing processes of the API.

• 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.

• Further, a TVS Product shall not be deemed to be the [*], or the [*], in each case, without the [*], even if such [*] is the subject of a separate regulatory filing, such as a Drug Master File.

• Notwithstanding the foregoing, it shall be the responsibility of (i) DANCE to obtain and maintain all such permits, approvals and licenses which are specific to the Active Ingredient or the Product, and (ii) JULPHAR to obtain and maintain all such permits, approvals and licenses which are generally required for the Production Site and to maintain the Drug Master File in respect of the Active Ingredient.

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 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 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 or “DMF” means a submission to EMA or other regulatory authority by JULPHAR 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 or “DMF” means a drug master file providing detailed information about the facility, the equipment and manufacturing processes relating to the API and Product and such other information as required by Applicable Laws, including 21 C.F.R. Section 314.420 and to the extent applicable any equivalent requirement in under Applicable Laws including as required by the Committee for Proprietary Medicinal Products Note for Guidance on the European Drug Master File Procedure for Active Ingredients.