Axplora consolidates UDCA manufacturing at India site to expand integrated API supply

Axplora, a global manufacturer of small molecule active pharmaceutical ingredients (API) and antibody-drug conjugates, is consolidating ursodeoxycholic acid (UDCA) manufacturing at its Vizag, India facility as part of a broader strategy to strengthen integrated API supply capabilities and support future growth.

According to the company, production will transition fully from its Gropello Cairoli, Italy site, operated within the Farmabios business unit, by the end of 2026. The consolidation follows a previously announced investment to expand UDCA manufacturing capacity at Vizag and establish a fully integrated production platform spanning bile sourcing through API manufacturing.

UDCA is used in therapies for chronic liver and gallbladder diseases with global demand increasing due to higher diagnosis rates, broader healthcare access in emerging markets, and growth in specialty therapeutics requiring reliable API supply, according to the announcement.

Axplora said the Vizag facility uses a proprietary enzymatic “green chemistry” manufacturing route designed to reduce process steps while minimizing solvent and reagent usage compared with conventional manufacturing methods. The site also incorporates backward integration and full traceability through controlled bile sourcing and integrated API production.

Martin Meeson, CEO of Axplora, said in a statement that consolidating manufacturing at Vizag creates “a more streamlined and scalable supply platform” while allowing the company’s Farmabios business to sharpen its focus on highly potent APIs and steroid manufacturing.

The company said the Vizag site has received regulatory approvals and recently completed a successful U.S. Food and Drug Administration inspection. The facility also holds an EcoVadis Silver sustainability rating and operates using equivalent manufacturing standards to the Gropello site, while offering additional expansion potential and direct access to FDA-approved infrastructure.

The consolidation follows other recent Axplora investments focused on advanced therapeutics manufacturing. Earlier this year, the company expanded lyophilization and ADC manufacturing capabilities at its Le Mans, France site to support payload, linker, and bioconjugation operations for antibody-drug conjugates. Axplora said the expansion is intended to reduce technology transfer complexity and accelerate development timelines for increasingly complex oncology therapies.