CordenPharma site passes Brazil’s ANVISA, South Korea’s MFDS GMP inspections

CordenPharma, a contract development and manufacturing organization (CDMO) headquartered in Basel, Switzerland, announced the successful completion of regulatory inspections by Brazil’s ANVISA and South Korea’s Ministry of Food and Drug Safety (MFDS) at its Plankstadt, Germany facility.

The ANVISA inspection, which focused on the manufacture of a highly potent drug product, concluded ahead of its planned five-day schedule and included a review of manufacturing areas, laboratories, warehouse operations and supporting technical functions, the company said. 

The MFDS inspection, conducted one week later, also spanned five days and evaluated end-to-end GMP systems for a first-in-class highly potent drug product, including engineering, documentation and operational compliance, according to the CDMO.

CordenPharma said both inspections resulted in zero observations, confirming the site’s GMP framework and its ability to manage complex, highly potent manufacturing processes. The company said the outcome supports its containment strategies and operational controls for handling highly potent compounds.

The Plankstadt facility’s inspection results come as the company continues to expand its global manufacturing and development footprint. Last month, CordenPharma announced an expansion of its peptide development capabilities in Boulder, Colorado, adding laboratory space to support process development and analytical services alongside its existing peptide API manufacturing operations.

The company said the expanded capabilities are intended to improve alignment between development and manufacturing activities and support growing outsourcing demand across its global network.