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DMF quality for international markets and Bharat.
The Drug Master File (DMF) includes detailed and accurate information about Active Pharmaceutical Ingredients (API) or Finished Product Dosage Forms, reviewed by the USFDA under USP and ICH guidelines. This certification mandates annual audits of manufacturing facilities to maintain consistent quality. Mankind Pharma ensures that all drugs produced for India and international markets comply with these stringent quality standards.
What is the
significance of DMF?
significance of DMF?
Confidentiality
Ensures confidentiality of proprietary information
FDA Approved
Safeguards public health by ensuring the safety of drugs
Quality
Penetrates the high entry barrier by maintaining international quality standards.
How does DMF ensure international standard quality?
DMF's detailed information on API or Finished Product Dosage Form, reviewed by USFDA per USP and ICH guidelines, along with annual facility audits, ensures higher quality standards than unregulated markets.
