US DMF: registering an API with the FDA

What is a US DMF?

A Drug Master File (DMF) is a submission to the US FDA containing confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drugs. For APIs, the relevant type is the Type II DMF (drug substance, intermediate, or material).

Why an API maker files a DMF

• It lets a US finished-product applicant reference the API's confidential data without the API maker disclosing it commercially.
• The DMF holder grants a Letter of Authorization (LOA) to specific applicants/products so the FDA can review the DMF in support of that application.
• A DMF number is a strong signal of a supplier's regulatory seriousness to US buyers.

DMF vs. CEP

• DMF — US mechanism, confidential, referenced via LOA.
• CEP — EU mechanism, certifies conformity to a public Ph. Eur. monograph.
• They are not interchangeable: US filings need a DMF; EU filings use CEP or EDMF/ASMF.

Keeping a DMF current

The holder must file annual reports and amendments to keep the DMF active. An out-of-date DMF cannot support a new application.

Our position

We hold US-DMF files for key products such as doxylamine succinate and norepinephrine bitartrate, and issue LOAs to qualified US partners. Ask us for the current DMF number and status for your product of interest.

DMF numbers and status should be confirmed with the FDA's public DMF index and directly with the holder.

Información exclusivamente general; no constituye asesoramiento jurídico ni regulatorio. Los requisitos cambian; confirme siempre con la autoridad competente.