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news.The US Food and Drug Administration (FDA) has successfully conducted pre-approval inspection at Canada-based contract manufacturing organization Pillar5 Pharma's facility, where IntelGenx' lead product CPI-300 is being manufactured.
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CPI-300, a novel antidepressant, with a high strength of bupropion hydrochloride (HCl), is the active ingredient in Wellbutrin XL.
Pillar5 has responded to all queries from the FDA for its pre-approval site inspection.
IntelGenx president and CEO Horst Zerbe said they are very excited to have passed another important milestone in their endeavors to bring CPI-300 to market and hopefully make this proprietary product available to patients who suffer from major depressive disorder.
IntelGenx has 10% ownership stake in Pillar5.