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 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).

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 or “DMF” shall mean the drug master file for a Product and the drug master file(s) for any excipients for that Product held by a Raw Materials manufacturer filed with the FDA (if any) as of the Effective Date in accordance with 21 CFR (chapter 314.420), and as subsequently supplemented from time to time.

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” means a Drug Master File maintained with the FDA under 21 C.F.R. § 314.420, or a filing with a Regulatory Authority outside the United States serving a purpose equivalent to that of a Drug Master File in the United States.

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 the Current Product or any 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.