Furoscix manufacturing depends on raw materials that are limited and sourced from one or a few suppliers. V-Go is produced by a contract manufacturing organization (CMO) in Southern China using MannKind-owned equipment, with additional CMOs in China responsible for testing, sterilization, inspection, and packaging. Components for V-Go are made to specifications, with some parts obtained from single-source vendors managed through a global supply chain. Alternative suppliers are considered available if needed. The nintedanib dry powder formulation is manufactured in Connecticut, with nintedanib sourced from generic drug substance suppliers. Suppliers and contract manufacturers are experienced multinational organizations subject to inspections and Good Manufacturing Practice (GMP) audits. Quality and manufacturing personnel qualify new vendors and regularly audit operations. Facilities of CMOs and critical suppliers are inspected by the FDA and other regulatory agencies.
Mannkind's Comment on Supply Chain
Furoscix manufacturing depends on raw materials that are limited and sourced from one or a few suppliers. V-Go is produced by a contract manufacturing organization (CMO) in Southern China using MannKind-owned equipment, with additional CMOs in China responsible for testing, sterilization, inspection, and packaging. Components for V-Go are made to specifications, with some parts obtained from single-source vendors managed through a global supply chain. Alternative suppliers are considered available if needed. The nintedanib dry powder formulation is manufactured in Connecticut, with nintedanib sourced from generic drug substance suppliers. Suppliers and contract manufacturers are experienced multinational organizations subject to inspections and Good Manufacturing Practice (GMP) audits. Quality and manufacturing personnel qualify new vendors and regularly audit operations. Facilities of CMOs and critical suppliers are inspected by the FDA and other regulatory agencies.
Sources:
Mannkind Corporation'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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