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.

Partnership Will Provide Pharmaceutical Grade Cannabinoid Active Ingredients to the Largest Pharmaceutical and Consumer Goods Names in the Industry
​22nd Century Group, Inc., a leading biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis and hops advanced plant technologies, today announced filing of a U.S. Drug Master File (DMF) to the US Food & Drug Administration (FDA) for cannabidiol (CBD) API from GVB Biopharma, a 22nd Century Group Company. The submission (DMF 037727) demonstrates 22nd Century Group’s absolute commitment to supplying high quality pharmaceutical grade API to the pharmaceutical industry and OTC markets.