SIGA Technologies Inc
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SIGA Technologies, Inc. is a commercial-stage pharmaceutical company. The Company’s lead product, TPOXX (oral TPOXX), is an oral formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. The Company does not have a manufacturing infrastructure and does not intend to develop one for the manufacture of TPOXX. It uses contract manufacturing organizations (CMOs) to procure commercial raw materials and supplies, and to manufacture TPOXX. The Company’s CMOs apply methods and controls in facilities, which are uses for manufacturing, processing, packaging, testing, analyzing and holding pharmaceuticals, which conform to current good manufacturing practices (cGMP), the standard set by the FDA for manufacture and storage of pharmaceuticals intended for human use. For the manufacture of oral TPOXX, the Company uses the four CMOs, namely W.R. Grace and Company; Powdersize, LLC; Catalent Pharma Solutions LLC, and Packaging Coordinators, LLC.
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