Abstract

PROCESSING AND SUBMISSION OF DRUG MASTER FILE

S. Anusha*, N.V.N. Mounica, V. Sharmila, S. Sravika, M. V. Nagabhushanam, D. Nagarjuna Reddy

ABSTRACT

A Drug Master File is a confidential document used to provide detailed information about facilities, processes or articles used in the manufacturing process, packaging and storing of one or more human drug. The Drug Master File may be utilized either by the holder who establishes the file, or by one or more additional parties in support of their application. The Drug Master File filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosure of processing details. The review includes various types of Drug Master Files, the important aspects in filing and processing.

Keywords: Drug Master File, Holder, Intellectual property, Regulatory requirements.