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Gnosis has announced US FDA approval for its API manufacturing facility in Pisticci, Italy.
The Pisticci facility also received quality approval from the Italian Ministry of Health (Moh) and EMEA. This state-of-the-art facility is engaged in the development and manufacturing of APIs and API intermediaries based on fermentation technology.
Commenting on this milestone, Fulvio Carlotti, quality assurance corporate director, said: "The US FDA approval endorsed our commitment to ensure strong regulatory compliance as well as our efforts to offer quality products through research. Being the first ever for the company, this approval will further set Gnosis among the finest global API manufacturers".
Gnosis has integrated its expertise in APIs production by fermentation with an advanced know-how on chemical synthesis and is thus able to offer development and production services for semi-synthetic drugs, including antibiotics.
The modular structure of the facility can accommodate different process flow models and is approved for handling BL2 and GMO microorganisms.
With proprietary bioprocesses for the production of bio-therapeutic molecules, Gnosis is in a position to participate in partnerships and customised collaborations, proposing process and product development services as well as tailor-made industrial production solutions.