Hovione’s API plant in Cork, Ireland has successfully passed a pre-approval inspection by the U.S. FDA. The five-day inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP), with no Form 483 observations.   Luisa Paulo, Hovione’s compliance director, said, “The pre-approval inspection was triggered by a client NDA filing, it also covered the manufacturing of a commercial NDA and a generic antibiotic, doxycycline. It is an...