Drug Master File (DMF)

A confidential submission to the FDA containing detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storage of a drug. Filed by API manufacturers, excipient suppliers, or packaging companies to support third-party drug applications without disclosing proprietary information directly to the applicant. There are five types (I-V), with Type II (Drug Substance/API) being the most common.

ตัวอย่าง

• Type II DMF for generic API sourcing
• Type III DMF for packaging materials
• Indian API manufacturers filing DMFs with FDA