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 agency visited Pillar5's Arnprior, Ontario manufacturing facility, a former Pfizer plant that dates from 1956. Pillar5 moved in in 2009 and employs about 100. IntelGenx release

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Learn how IPM.ai transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.