Axplora has announced the consolidation of ursodeoxycholic acid (UDCA) manufacturing at its Vizag facility in India, which operates under the PharmaZell business unit. The company stated that production will transition fully from its Gropello Cairoli facility in Italy, part of 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 establish an integrated production platform covering bile sourcing through to active pharmaceutical ingredient (API) manufacturing.
According to the company, the consolidation forms part of its strategy to strengthen its position as a drug substance provider by maintaining its focus on APIs. The company stated that the move also aligns with its approach of leveraging the capabilities of its PharmaZell, Farmabios and Novasep CDMO business units to support operational focus, scalability and customer requirements.
UDCA is a bile acid-derived API used in therapies for chronic liver and gallbladder diseases. Axplora stated that demand for UDCA continues to increase globally due to the diagnosis and treatment of chronic liver conditions, healthcare access in emerging markets and the pharmaceutical industry’s focus on specialty therapies requiring API supply.
Manufacturing at the Vizag facility uses Axplora’s enzymatic synthesis route, which the company said reduces process steps and minimises the use of solvents and reagents compared with conventional manufacturing methods. The site also incorporates backward integration and traceability through controlled bile sourcing and integrated API production.
The Vizag facility has received an EcoVadis Silver sustainability rating. According to the company, the site operates using the same enzymatic process and manufacturing standards as the Gropello facility while providing expansion capacity, integrated operations and access to US FDA-approved infrastructure.
Martin Meeson, Chief Executive Officer, 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.”
The company stated that Farmabios is recognised for its steroid and highly potent active pharmaceutical ingredient (HPAPI) handling capabilities and operates an OEB5 manufacturing workshop in Europe. The facility supports complex and highly potent therapeutics within Axplora’s manufacturing network.
Anant Barbadikar, President, 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.
For customers, the benefits are clear: a fully integrated manufacturing platform, robust and traceable supply chains, scalable capacity and enhanced responsiveness. We are bringing together deep process expertise and operational efficiency to support long-term customer partnerships and reliable global supply.”
Axplora stated that regulatory approvals for the transition are now in place and that UDCA is being manufactured at the Vizag site. The company added that following a recent US FDA inspection, the facility is positioned to support customer demand and market growth through its integrated operations and manufacturing capacity.