Drug Master File

Drug Master File. Shall mean a drug master file, when filed by PN or medac, as required under the United States Food Drug & Cosmetic Act, and under the regulations promulgated thereunder, specifically 21 C.F.R. 314.420, et. seq., and any successor regulations thereto, and any other Regulatory Authority.

Drug Master File. Means a submission to the FDA as described in 21 C.F.R. Section 314.420, or successors thereto, providing detailed information about facilities, processes, and/or articles used in the manufacturing, processing, packaging, and/or storing of the Product.

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. Mean a reference file submitted by DSP to the FDA that is used in the review of investigational and marketing applications for human drugs and that, at a minimum, contains all information and know-how necessary to manufacture the Compound.

Drug Master File. Means the drug master file for Product in the U.S. (as such term is defined in 21 C.F.R. Part 314.420) or an equivalent filing in the Territory.

Drug Master File. A drug master file providing detailed information about the Facility, the equipment and the Manufacturing Processes relating to the Product and such other information as required by Applicable Laws, including 21 C.F.R. Section 314.420, and to the extent applicable of any equivalent requirement under Applicable Laws.