In:
International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 11, No. 3 ( 2023-09-19), p. 33-38
Abstract:
Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the applicable authority in the intended drug market. The document provides the non-supervisory authority with confidential, detailed information about installations, processes, or papers used in the manufacturing, processing, packaging, and storing of one or further mortal drugs. The DMF form allows an establishment to cover its intellectual property from its mate while complying with non-supervisory conditions for exposure of processing details. There is no non-supervisory demand to file a DMF. Drug Master Files (DMF) is a document containing complete information on an Active Pharmaceutical element (API) or finished drug capsule form. Though there are no non-supervisory conditions to file a DMF, the benefit of its use is inviting. A drug Master Files (DMF) is an voluntary non-supervisory submission and is submitted at the discretion of the DMF holder to help their guests. A DMF is NOT a cover for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. An Active Substance Master File (ASMF) is the presently honored term in Europe, formerly known as European drug Master file (eDMF) or a US- Drug Master File( US- DMF) in the United States.
Type of Medium:
Online Resource
ISSN:
2321-6794
,
2321-7162
DOI:
10.22270/ijdra.v11i3.613
Language:
Unknown
Publisher:
Society of Pharmaceutical Tecnocrats
Publication Date:
2023
detail.hit.zdb_id:
2738279-5
SSG:
15,3
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