Milestone Achieved: 4th FDA Acceptance Letter Granted for Epinephrine Base US-DMF 030997

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.