DMF contains factual and complete information of API w.r.t. its chemistry, stability, purity, etc., which essentially defines the quality of any pharmaceutical drug.
What is Drug Master File (DMF)?
Drug Master File (DMF) is an elective regulatory submission for assisting regulatory requirements and to support the approval process for supplying drugs to the United States and other regulated countries.
DMF is a confidential document, prepared by the drug products manufacturer or excipient which contains comprehensive, accurate, and precise information about the Active Pharmaceutical Ingredient (API) or Finished Product Dosage Form’s (FP), including its chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP (Current Good Manufacturing Practices) status, for submission to the targeted market's regulatory authority. The DMF is filed to support the regulatory requirements of a medicinal product to prove its quality, safety, and efficacy.
What is significance of DMF?
Ensures confidentiality of proprietary information;
Provides international quality standards to the customers, the drugs are manufactured in USFDA approved facilities;
Penetrates the high entry barrier by maintaining international quality standards.
How DMF product does assure quality of International Standards?
Since, DMF contains comprehensive, accurate, and precise information about the Active Pharmaceutical Ingredient (API) or Finished Product Dosage Form’s reviewed by USFDA as per USP (US pharmacopoeia) and ICH (International Council Of Harmonization) prescribed guidelines, and also to ensure consistent quality the manufacturing facilities are audited annually, this by default ensures better quality standards then the unregulated markets.