Axplora is moving all UDCA production to its Vizag site in India, consolidating global manufacturing and expanding integrated API supply capacity.

Axplora has announced it is consolidating manufacturing of ursodeoxycholic acid (UDCA) at its Vizag site in India, shifting all production away from its Gropello Cairoli facility in Italy by the end of 2026. The change is part of a wider restructuring of the company’s global API network, designed to increase integration across sourcing, production and supply while reallocating site responsibilities within its business units PharmaZell, Farmabios and Novasep CDMO.

The company said the move follows earlier investment to expand UDCA capacity in Vizag and develop a fully integrated production system covering bile sourcing through to final active pharmaceutical ingredient manufacturing. UDCA is a bile acid-derived API used in treatments for chronic liver and gallbladder diseases, with demand increasing due to higher diagnosis rates and broader access to care in emerging markets.

Manufacturing at Vizag uses Axplora’s enzymatic synthesis route, which the company describes as “green chemistry” compared with conventional multi-step processes. The approach reduces the number of production steps and limits solvent and reagent use. The site also operates with backward integration and traceability across controlled bile sourcing and API manufacturing.

Axplora said Vizag will now act as its central production hub for UDCA, benefiting from expanded capacity and US FDA-approved infrastructure. The company also highlighted that the site has received an EcoVadis Silver sustainability rating and operates to the same manufacturing standards as the Gropello facility.

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.”

He added that the consolidation also supports a clearer operational focus across the group’s sites, particularly as Farmabios concentrates on high potency and steroid manufacturing capabilities within Axplora’s network.

Farmabios is positioned within the company as a specialist centre for steroid and high potency active pharmaceutical ingredients, including large-scale OEB5 containment manufacturing in Europe. Axplora said this specialisation will allow it to allocate more complex and potent therapeutic production to that site while expanding more standardised, high-volume API manufacturing in India.

Anant Barbadikar, president of PharmaZell operations, said: “Our Vizag site has become an increasingly important strategic hub within Axplora’s global manufacturing network. This consolidation reflects the technical expertise, operational excellence and regulatory track record of our Indian teams.”

He added that the change strengthens supply chain reliability and responsiveness for customers, pointing to integrated operations and scalable capacity as key advantages of the Vizag model.

“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 fully positioned to support current customer demand and future market growth through a secure, reliable and globally competitive supply platform.”

Overall, the announcement reflects a manufacturing network realignment rather than a pipeline expansion or clinical development update. It consolidates production into a single expanded site in India while repositioning European facilities toward higher potency and more specialised API production, aligning capacity with product complexity and demand profile across Axplora’s global operations.