The 9,500m² site features two fully automated production lines for liquid and lyophilized drug products, supporting a wide range of therapeutic areas, including highly potent compounds and ...

The Certificates, requested by HYTN in February, are important for drug registrations in jurisdictions where they apply. They also provide assurance in regions with limited regulatory frameworks, ...

The certification joins our long list of global regulatory achievements, including US FDA, Australian TGA, European Union pharmaceutical GMP and Canadian pharmaceutical GMP authorizations.

The threshold to qualify for a Good Manufacturing Practice (GMP) certification has been raised and will come into effect on Jan. 1 next year.

The inspection, conducted from 20-24 January, follows the site’s opening in February 2023. This is the first inspection of a routine process by ANSM to ensure compliance with Good Manufacturing ...

As a result, CARBOGEN AMCIS has been granted a GMP certificate for the Saint-Beauzire facility, marking a significant milestone in the site's successful start-up.

BUBENDORF, Switzerland, March 24, 2025 (GLOBE NEWSWIRE) -- Switzerland-based CARBOGEN AMCIS, a leading pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing ...