Two FDA Drug Master Files submitted: helping U.S. radiopharmacies move faster with confidence

Sterile, time-sensitive, and highly regulated: radiopharmaceutical production leaves little margin for administrative delays. That is why regulatory readiness matters as much as operational performance.

Trasis has successfully submitted two Drug Master Files (DMFs) to the U.S. Food and Drug Administration (FDA), available for reference by our U.S. customers:

DMF 034758 — “The synthesis of [18F]FDG quad/dual+ on Trasis AllinOne synthesizer”
QC1 DMF (Type V) — DMF 039848

What a DMF changes for our customers

An FDA DMF is a confidential regulatory dossier that allows a third party to reference detailed information in their own submissions without having to receive the full proprietary file directly.
In practice, this can help radiopharmacies and industry sponsors reduce documentation burden, de-risk the quality narrative, and accelerate timelines when preparing U.S. regulatory submissions—via an authorized reference mechanism (Letter of Authorization).

Why this matters now?

As radiopharmaceutical pipelines expand, so do expectations on quality, consistency, and traceability. These DMF submissions support our role as a facilitator for nuclear medicine stakeholders—helping teams simplify, secure, and speed up the path from development to production and, ultimately, patient administration.

How to reference these DMFs

If you are a U.S. customer and would like to reference one of these DMFs in a regulatory filing, contact Trasis to request the appropriate authorization pathway and next steps.

Meet us at SNMMI Mid-Winter (Orlando, Jan 22–24, 2026)
Manu Bertrand will be on-site—reach out to schedule a meeting.