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Expanded Access and Commercial Packaging Strategies for Orphan, Niche, and Low-Volume Drugs

Summary: Most commercial contract drug packagers do not provide consistent scheduling for low-volume drugs, which creates supply challenges. In fact, a drug packaging delay can create a market shortage that triggers serious health consequences for patients who rely on the drug. This issue can arise with niche and orphan drugs, as well as any other drugs packaged in small volumes. Conversely, a clinical supply partner can provide packaging as needed, plus handle distribution for expanded access and general commercial needs. This summary describes low-volume drugs, examines commercial packaging and supply challenges, and explores potential solutions.

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