The company relies on suppliers and contract manufacturers who must comply with stringent quality assurance procedures throughout the manufacturing process. Its supply chain is regulated by laws including the Combat Methamphetamine Epidemic Act of 2005, which controls the importation of ephedrine-containing products, and the Drug Supply Chain Security Act of 2013, which requires product tracking, labeling, and record-keeping to prevent counterfeit or adulterated products. Manufacturing delays may occur due to permitting and quota processes. Suppliers, contract manufacturers, laboratories, packagers, and distributors are subject to potential enforcement actions by the Drug Enforcement Administration (DEA) that could disrupt supply. The company is currently evaluating whether to discontinue its agreement with supplier Aguettant due to market competition and a strategic focus on nafamostat product candidates.
Talphera Inc's Comment on Supply Chain
The company relies on suppliers and contract manufacturers who must comply with stringent quality assurance procedures throughout the manufacturing process. Its supply chain is regulated by laws including the Combat Methamphetamine Epidemic Act of 2005, which controls the importation of ephedrine-containing products, and the Drug Supply Chain Security Act of 2013, which requires product tracking, labeling, and record-keeping to prevent counterfeit or adulterated products. Manufacturing delays may occur due to permitting and quota processes. Suppliers, contract manufacturers, laboratories, packagers, and distributors are subject to potential enforcement actions by the Drug Enforcement Administration (DEA) that could disrupt supply. The company is currently evaluating whether to discontinue its agreement with supplier Aguettant due to market competition and a strategic focus on nafamostat product candidates.
Sources:
Talphera 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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