The company manufactures clinical supplies of injectable extended-release and solid dosage form products at its Wilmington, Ohio facility. It also contracts with third-party manufacturers to formulate and produce certain clinical-use products in compliance with current Good Manufacturing Practice (cGMP) standards. The company holds multiple permits and licenses for manufacturing activities, including FDA Drug Establishment Registrations, DEA licenses, and authorizations from the Health Products Regulatory Authority in Ireland. Manufacturer Authorizations for the Athlone Facility were transferred to Novo following the sale of that facility in May 2024. Novo is identified as a supplier in company filings.
Alkermes Plc's Comment on Supply Chain
The company manufactures clinical supplies of injectable extended-release and solid dosage form products at its Wilmington, Ohio facility. It also contracts with third-party manufacturers to formulate and produce certain clinical-use products in compliance with current Good Manufacturing Practice (cGMP) standards. The company holds multiple permits and licenses for manufacturing activities, including FDA Drug Establishment Registrations, DEA licenses, and authorizations from the Health Products Regulatory Authority in Ireland. Manufacturer Authorizations for the Athlone Facility were transferred to Novo following the sale of that facility in May 2024. Novo is identified as a supplier in company filings.
Sources:
Alkermes Plc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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