SIGA Pharmaceuticals utilizes multiple contract manufacturing organizations (CMOs) for the production of TPOXX®. For the oral formulation, SIGA engages W.R. Grace and Company (Grace), which acquired Albemarle's Fine Chemistry Services Business in 2021, Microsize (formerly Powdersize, LLC), Catalent Pharma Solutions LLC (Catalent), and Packaging Coordinators, LLC (PCI). Grace is responsible for manufacturing, testing, and supplying the active pharmaceutical ingredient (API) for TPOXX®, with agreements requiring SIGA to purchase a majority of its API from Grace until specified conditions are met. Microsize micronizes and tests the API. Catalent handles granulation, encapsulation, testing of oral TPOXX®, and provides commercial stability testing and analysis. PCI offers packaging services for both oral and intravenous TPOXX® formulations. The agreements with these suppliers include various terms and automatic renewal provisions.
Siga Technologies Inc's Comment on Supply Chain
SIGA Pharmaceuticals utilizes multiple contract manufacturing organizations (CMOs) for the production of TPOXX®. For the oral formulation, SIGA engages W.R. Grace and Company (Grace), which acquired Albemarle's Fine Chemistry Services Business in 2021, Microsize (formerly Powdersize, LLC), Catalent Pharma Solutions LLC (Catalent), and Packaging Coordinators, LLC (PCI). Grace is responsible for manufacturing, testing, and supplying the active pharmaceutical ingredient (API) for TPOXX®, with agreements requiring SIGA to purchase a majority of its API from Grace until specified conditions are met. Microsize micronizes and tests the API. Catalent handles granulation, encapsulation, testing of oral TPOXX®, and provides commercial stability testing and analysis. PCI offers packaging services for both oral and intravenous TPOXX® formulations. The agreements with these suppliers include various terms and automatic renewal provisions.
Sources:
Siga Technologies Inc'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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