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DMF

Meaning

In the pharmaceutical and regulatory context of hormonal health, DMF stands for Drug Master File, a confidential document submitted to a regulatory authority, such as the FDA, detailing the complete chemistry, manufacturing, and control (CMC) information for a specific active pharmaceutical ingredient (API) or drug substance. This file contains proprietary details about the facility, processes, and quality assurance measures used in the synthesis of a hormonal compound. The DMF allows a pharmaceutical company to reference the API data without disclosing the manufacturer’s confidential intellectual property to the drug product applicant.