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.

In women’s health, reliability is everything. Since 2014, Transo-Pharm and the German manufacturer HAPILA GmbH have joined forces to ensure a stable and high-quality supply of Estriol – an essential hormone with global relevance.
 
When demand for micronized Estriol (CEP No.: R1-CEP 2013-277-Rev 00) increased, both companies made a bold move: to invest in the future. In 2019, we decided to expand capacity at HAPILA’s site in Gera, Germany. Just one year later, construction began on a new GMP-compliant facility – now fully operational.
 
The result: a stronger, more resilient supply chain that meets today’s needs and prepares for tomorrow’s.
 
Because innovation is more than new buildings and machines – it’s about partnerships that make reliable therapies possible.
 
📹 Watch the video and see how we build the future of Estriol supply, together.

It has been three weeks now since the pharma world met in Milan for the CPHI 2024.

Three intensive days in this beautiful city were worth the efforts as they brought a lot of ideas to light, which we are now working on.
 
The whole Transo-Pharm team enjoyed meeting up with our friends and partners  – be it at a table at the Transo-Pharm booth or during our Happy Hour event with a glass of wine in our hands.
 
We are already looking forward to seeing you all again in Frankfurt in 2025.

Transo-Pharm Handels-GmbH and HAPILA GmbH are determined to deepen their relationship and have therefore jointly decided to expand the production capacities at the HAPILA site in Gera, mainly to meet the increasing demand for the active ingredient Estriol Micronized.

The planning for the construction and installation work started in 2020.

​The new facility is expected to be completed in 2022. 

For more information please download attachements (German or English available).