Axplora Consolidates UDCA Manufacturing at FDA-Approved Vizag Site by End of 2026

A full site transfer of ursodeoxycholic acid (UDCA) production from Italy to India signals how Axplora is restructuring its API supply model around integrated, scalable infrastructure rather than distributed legacy capacity. Production at the Gropello Cairoli facility within the Farmabios business unit will cease by end of 2026, with all UDCA output consolidating at the company's Vizag site under the PharmaZell business unit.

The Vizag facility carries US FDA-approved status and operates Axplora's proprietary enzymatic synthesis route, a green chemistry process that reduces solvent and reagent use relative to conventional manufacturing. Backward integration from controlled bile sourcing through to finished API gives the site full supply-chain traceability, a feature increasingly weighted by procurement and QA teams managing supplier qualification under ICH Q10 and 21 CFR Part 211 frameworks. The site also holds an EcoVadis Silver sustainability rating.

For plant heads and supply-chain leads, the consolidation addresses a recurring vulnerability in multi-site API networks: split production across geographies with differing regulatory footprints. Concentrating UDCA at a single FDA-inspected site with expansion headroom reduces the compliance surface area and simplifies change-control obligations tied to dual-site process validation.

The reallocation also reshapes Farmabios' operational mandate. Freed from UDCA production, the Gropello Cairoli site will concentrate on steroids and highly potent API (HPAPI) manufacturing, where it operates one of the largest OEB5 workshops in Europe. That refocus positions Farmabios as a dedicated containment centre within Axplora's three-unit network alongside PharmaZell and Novasep CDMO, each carrying a distinct technical remit.

UDCA demand is rising on the back of growing diagnosis rates for chronic liver and gallbladder conditions and expanding specialty-therapy pipelines in emerging markets. Axplora's move to anchor supply at a single integrated site with stated scalability is a direct response to that demand trajectory, and to customer expectations around supply continuity and auditability.

The completion of the Vizag transition by end of 2026 will serve as the near-term benchmark for whether the consolidated platform delivers the responsiveness and capacity headroom Axplora has committed to customers.

Source: Axplora via company press release, 10 June 2026.