X Pharma Plus, with its skilled Regulatory team, specializes in FDA Drug Master File (DMF) submissions, ensuring full compliance with GDUFA II and Industry Coordinating Agreement (ICA) requirements. Our expertise facilitates timely approvals, enabling manufacturers to efficiently provide access to multiple applications through Letters of Access (LoA).
Drug Master File (DMF) Submissions – Overview
Drug Master File (DMF) submission to the US FDA is not mandatory, as DMFs are neither formally approved nor disapproved. However, manufacturers and DMF holders often submit independent DMFs for drug substances, excipients, and packaging materials to maintain confidentiality and facilitate access to multiple applications.
To comply with the Generic Drug User Fee Act (GDUFA) II and Initial Completeness Assessment (ICA) requirements of the US FDA, DMF holders must ensure that their submissions meet FDA prerequisites. A compliant DMF enables the holder to provide Letters of Access (LoA) for applications such as INDs, NDAs, and ANDAs.
X Pharma Plus possesses a highly skilled and dedicated Regulatory team specializing in FDA DMF submissions. Our team has extensive expertise in preparing, submitting, and managing DMFs for drug substances, excipients, and packaging materials in full compliance with US FDA requirements.
Drug Master File (DMF) Submissions – Services
“Confidential submission to the FDA containing detailed information on the manufacturing, processing, packaging, and storage of drug substances or components to support regulatory applications.”
- Type II: Drug substance and drug substance intermediates
- Type III: Packaging materials
- Type IV: Excipients, colorants, flavors, essences, or materials used in their preparation