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“From Source” on the front, “To Finish” on the back—the motto for our relay race couldn’t have been more fitting. Together with our colleagues, we headed to "Stadtpark" in Hamburg, and from there, the runners made their way to the starting line. The focus wasn’t just on athletic performance, but above all on team spirit. Together, we turned many individual runs into a fantastic event with a strong sense of community. Of course, the typical Hamburg weather made an appearance as well. But the rain and gray skies couldn’t dampen the good mood. With plenty of motivation, team spirit, and mutual support, our team took to the starting line and gave it their all—all the way to the finish line. And one thing is certain: From Source to Finish—we simply perform better together!
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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. We are delighted to announce another significant achievement in the Estriol capacity expansion project – a joint initiative between Hapila GmbH and Transo-Pharm Handels-GmbH.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has approved the extension of the Certificate of Suitability (CEP) for micronized Estriol. The CEP now covers not only our existing manufacturing facility (GMP Plant I), but also the newly commissioned GMP Plant III. This approval significantly strengthens the robustness of our supply chain, effectively doubles our production capacity, and further enhances supply security for our partners worldwide. By combining Hapila’s manufacturing and regulatory capabilities with Transo-Pharm’s commercial expertise, we continue to invest in a reliable, future-proof supply chain for Estriol and other high-quality pharmaceutical active ingredients. Together, we are building a stronger, more resilient future for Estriol supply – driven by collaboration, quality, and long-term commitment. The upcoming CPHI China in Shanghai is just around the corner, taking place from June 16 to 18, 2026 – and Transo-Pharm will be there!
Take the opportunity to meet our team members, Jessica Ha and Xiding Geng, live at the event. To ensure we have dedicated time for your inquiries, please contact Jessica Ha to schedule an appointment in advance. See you in Shanghai!
For us at Transo-Pharm, supply continuity has always been part of our DNA and for our life saving Epinephrine it is truly a matter of the heart. In order to ensure a resilient supply chain for this API, we have already established a 2-year safety stock initiative in order to ensure availability of Epinephrine and to avoid shortages. We are proud to say, that we did not experience any supply problems during the last pandemic.
We are now taking the next step toward strengthening our security supply by establishing hameln rds s.r.o. in Modra, Slovakia, as a second manufacturing location. Transo-Pharm has qualified the site and the new CEPs for Epinephrine Base and Bitartrate have already been granted by EDQM (Adrenaline & Adrenaline tartrate) end of 2025. Important: We will submit an amendment to our US-DMF by April of this year to add hameln rds s.r.o. as an alternative site. If you have any further questions about our supply chain optimization project, please visit us at this year’s DCAT in New York. You can find us at the Lotte Hotel New York Palace from March 23 to 26, 2026. Our Epinephrine product manager Jessica Ha looks forward to seeing you there. If you wish to make an appointment, please contact [email protected]
As the year draws to a close, the Christmas season provides a moment to reflect on the values of goodwill, gratitude, and togetherness. It is a time to appreciate the relationships and shared efforts that have shaped the year gone by. We extend our sincere Season’s Greetings and thanks to all those who have been part of our journey. As we look ahead to the New Year, we wish you peace, joy, and continued success. Merry Christmas and a prosperous New Year. Frankfurt is known for its skyscrapers – typical for Manhatten. That is why the Germans sometimes say “Mainhatten” to Frankfurt since the city is located on the river Main. Frankfurt is a special and unique place and so is the CPhI. So many people from all around the globe, with different backgrounds and cultures, coming peacefully together for one large event is something distinct. The CPhI is not just about meeting customers or suppliers, it is far more than that. To talk, listen and understand each other, be it small talk or business talk. What matters is the respectful interaction. That is what you find at the CPhI – hope you seek the same. The entire Transo-Pharm team looks forward seeing you in Frankfurt. |
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