Summary
Cencora, Inc. (formerly AmerisourceBergen Corporation) provided an update on its subsidiary, PharMEDium, concerning the 503B compounding facility in Memphis, Tennessee. The company is making substantial progress towards enhancing patient safety and achieving full regulatory compliance after previously informing the FDA of its intent to resume limited production. PharMEDium has submitted a third-party cGMP audit report to the FDA and plans to submit its evaluation and planned actions imminently. The company anticipates commencing commercial distribution in fiscal 2018, with gradual production increases leading to full operational status in fiscal 2019, absent further FDA feedback. Financial guidance for fiscal year 2018 remains unchanged, and the company will provide a further update in November 2018. Cencora reiterates its commitment to patient safety and meeting market demand for compounded sterile preparations, aiming to maintain its market leadership in quality. The filing also includes a standard cautionary note regarding forward-looking statements and potential risk factors affecting the company's business.
Key Highlights
- 1PharMEDium's Memphis 503B compounding facility is showing substantial progress in enhancing patient safety and regulatory compliance.
- 2A third-party cGMP audit report for the Memphis facility has been submitted to the FDA.
- 3PharMEDium plans to submit its evaluation of the audit report and planned corrective actions to the FDA on September 6, 2018.
- 4The company expects to commence commercial distribution from the Memphis facility in fiscal 2018, provided there is no further FDA feedback.
- 5Full operational status for the Memphis facility is anticipated in fiscal 2019, with gradual production increases after distribution resumes.
- 6Cencora's fiscal year 2018 financial guidance remains unchanged.
- 7The company's top priority is patient safety and achieving full regulatory compliance.