We are pleased to announce that we have once again received two acceptance letters from the U.S. FDA for our U.S. Drug Master File 030997 for Epinephrine/Adrenaline dated October and December 2025.
Following our initial DMF submission in 2018, we have successfully accumulated four U.S. FDA acceptance letters for our Drug Master File 030997.

An FDA acceptance letter for a DMF confirms that the submission has successfully passed the agency’s administrative review and has been accepted for reference in support of regulatory submissions, including Abbreviated New Drug Applications (ANDAs). This represents an important regulatory milestone and reflects the quality and completeness of the information provided in our DMF.

This milestone reflects our continued commitment to high-quality regulatory documentation and excellence in supporting our customers’ development and registration efforts.

We thank our team for their dedication and contribution to this achievement.

Enantiomeric purity in chiral molecules – such as Transo-Pharm’ s Epinephrine Base and Bitartrate – have been in the focus of the health authorities for some time now. Transo-Pharm is well prepared to fully satisfy the more stringent requirements with their state-of-the-art stereo-selective manufacturing process. Transo-Pharm is therefore in the position to achieve an Enantiomeric Excess (ee) of 99% in commercial production for several years now. This is a significant contribution to ensure patient safety.

Please find the full article below. Learn more about the science behind this topic.

No Nitrosamine risk with Epinephrine Base / Bitartrate from Transo-Pharm as our recently conducted risk evaluation report reveals.

The conclusion is now available on request.