Tag:
Pre Approval
Latest Headlines
Latest Headlines
Ex-Pfizer facility has successful pre-approval inspection
CMO Pillar5, selected by IntelGenx to manufacture its high-strength CPI-300 bupropion hydrochloride antidepressant, has passed its FDA pre-approval inspection with no Form 483 being issued. The
German dose form plant ok'd
Just three minor Form 483 observations followed a pre-approval inspection of New Jersey-based Catalent Pharma's integrated dose form development, manufacturing and packaging facility in Schorndorf,
