Small molecule manufacturer Axplora has announced it will be consolidating its ursodeoxycholic acid (UDCA) manufacturing, transitioning production from its Vizag, India site (part of the PharmaZell business unit) to the company’s Gropello Cairoli, Italy site.
The transition is expected to be completed 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.
UDCA is a bile acid-derived pharmaceutical ingredient used to treat chronic liver and gallbladder diseases.
Demand for UDCA has been increasing globally due to more diagnoses and treatments for liver conditions, improved healthcare access in emerging markets and the pharmaceutical industry's focus on reliable, high-quality speciality therapies.
The company added in its statement that the consolidation also reflects its 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."
The Vizag facility employs Axplora's proprietary enzymatic "green chemistry" synthesis, streamlining the manufacturing process by minimising the steps and reducing the use of solvents and reagents.
It features backward integration and complete traceability through controlled bile sourcing and integrated API production.
The facility has also earned an EcoVadis Silver sustainability rating and shares the same manufacturing standards as the Gropello site, while offering enhanced operational capabilities 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."
Farmabios is globally recognised for its steroid and HPAPI handling and operates one of Europe's largest OEB5 manufacturing workshops.
This site is vital to Axplora’s network, supporting complex and potent therapeutics.
Anant Barbadikar, President of PharmaZell — Operations, added: "Our Vizag site has become an increasingly important strategic hub within Axplora’s global manufacturing network."
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."
With regulatory approvals secured, UDCA is now being produced at Axplora’s Vizag facility.