Drug Master File (DMF) Submission Expertise

Drug Master File (DMF) includes information about facilities and processes used in the manufacturing, processing, packaging and storing of one or more human drugs and it is submitted to support generic drug application and contains complete information of an Active Pharmaceutical Ingredient (API) or finished dosage form. It is referred to as US-Drug Master File (US-DMF) in the United States and Active Substance Master File (ASMF) in the EU. API manufacturers can also file Certification of Suitability (CEP) with the European Directorate for the Quality of Medicines and HealthCare (EDQM). Most of the emerging markets, in addition to Australia, Canada and all the European Union (EU) countries accept CEP instead of ASMF/DMF submissions.

Freyr has well defined processes for creating, publishing and dispatching the existing and new ASMF/DMFs in eCTD/NeeS/PDF format, as per the Health Authority requirements, along with providing pre-assigned application number for eCTD submissions. Our well-versed Regulatory team keeps track of region-specific DMF submission requirements and assists customers with effective DMF lifecycle management services including, amendments and annual report for quick submission turnaround times.

Latest Resources

  • Blogs

    API Guidance Notes – Decode NPRA Malaysia Guidance

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  • White Papers

    Control of Nitrosamines in Drug Products Regulatory Considerations

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  • Past Webinars

    Competitive Generic Therapies (CGT) - FDA Requirements

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