Drug Master File
A confidential document submitted to the FDA containing detailed manufacturing, processing, and quality information about a drug substance or component. Peptide manufacturers file DMFs to allow their customers (drug product applicants) to reference the manufacturing data without disclosing proprietary details.
Technical Context
DMF types: Type I (manufacturing site/facilities/operating procedures — discontinued since 2000), Type II (drug substance/drug substance intermediate/material used in their preparation — the most common type for peptide APIs), Type III (packaging materials), Type IV (excipients/agents/flavours/colours), Type V (FDA-accepted reference information). When a drug product applicant (NDA/ANDA sponsor) needs to reference a peptide manufacturer's proprietary information (synthesis route, purification methods, impurity profiles, specifications, stability data), the manufacturer files a Type II DMF with the FDA. The DMF holder issues a Letter of Authorization allowing the applicant to reference the DMF. This system enables peptide API manufacturers to protect trade secrets while allowing their customers to satisfy regulatory requirements. The FDA does not independently review or approve DMFs — they are reviewed only in the context of an associated application.