Axplora Repositions European Site on High-Potency Drugs as India Takes Over UDCA Production
Axplora is repositioning its Italian Farmabios site on high-potency APIs as UDCA production moves to its FDA-approved Vizag facility in India, consolidating supply and scaling for global demand.
Axplora, a global manufacturer of small-molecule APIs and ADCs for the pharmaceutical industry, recently announced the strategic consolidation of ursodeoxycholic acid (UDCA) manufacturing at its Vizag, India site, part of the PharmaZell business unit. Production will transition fully from the company’s Gropello Cairoli, Italy, site within the Farmabios business unit by the end of 2026.
The move follows Axplora’s previously announced investment in Vizag to expand UDCA manufacturing capacity and create a fully integrated production platform, from bile sourcing through to API manufacturing.
Axplora continues to be centred on strengthening its position as a dedicated drug substance provider to our customers by remaining fully focused on APIs. The consolidation also reflects Axplora’s broader strategy of leveraging the complementary strengths of its three business units — PharmaZell, Farmabios and Novasep CDMO — to deliver greater operational focus, scalability and customer value.
UDCA is a bile acid-derived active pharmaceutical ingredient widely used in therapies for chronic liver and gallbladder diseases. Demand for UDCA continues to grow globally, driven by increasing diagnosis and treatment of chronic liver conditions, expanding healthcare access in emerging markets and the pharmaceutical industry’s focus on specialty therapies requiring highly reliable, high-quality API supply.
Manufacturing at Vizag uses Axplora’s proprietary enzymatic “green chemistry” synthesis route, reducing process steps and minimizing the use of solvents and reagents compared with conventional manufacturing approaches. The site also benefits from backward integration and full traceability through controlled bile sourcing and integrated API production.
The Vizag facility operates using the same enzymatic process and equivalent manufacturing standards as the Gropello site, while providing additional expansion potential, integrated operations and direct access to US FDA-approved infrastructure.
Martin Meeson, CEO of Axplora, said: “This decision reflects the strategic advantage of Axplora’s integrated global network and our ability to align investments with evolving customer needs. By consolidating UDCA manufacturing at Vizag, we are creating a more streamlined and scalable supply platform that strengthens resilience, simplifies operations and enhances service for customers worldwide.
At the same time, it reinforces Farmabios’ position as a leading centre of excellence for highly potent APIs. As demand for increasingly complex and potent therapies continues to grow, we are focusing the site on the advanced containment and HPAPI capabilities where it delivers exceptional value to customers.”
With regulatory approvals now in place, UDCA is now being manufactured at Axplora’s Vizag site. Backed by a successful recent US FDA inspection, integrated operations, and scalable capacity, Vizag is well positioned to support current customer demand and future market growth through a secure, reliable, and globally competitive supply platform.
