The manufacture, packaging, shipment, storage, sale, and use of the controlled substance OLINVYK are regulated by the Drug Enforcement Administration (DEA), which enforces strict security measures and requires annual facility registration. The DEA sets production quotas for Schedule I and II substances, potentially limiting the availability of active ingredients from contract development and manufacturing organizations (CDMOs). Delays or refusals by the DEA in establishing quotas for CDMOs can affect clinical trials, product launches, and order fulfillment. The company and its CDMOs must comply with both federal and state regulations governing the handling and distribution of controlled substances.
Trevena Inc's Comment on Supply Chain
The manufacture, packaging, shipment, storage, sale, and use of the controlled substance OLINVYK are regulated by the Drug Enforcement Administration (DEA), which enforces strict security measures and requires annual facility registration. The DEA sets production quotas for Schedule I and II substances, potentially limiting the availability of active ingredients from contract development and manufacturing organizations (CDMOs). Delays or refusals by the DEA in establishing quotas for CDMOs can affect clinical trials, product launches, and order fulfillment. The company and its CDMOs must comply with both federal and state regulations governing the handling and distribution of controlled substances.
Sources:
Trevena 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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