PTSM: Pharmaceutical Technology Sourcing and Management
Xcellience receives approval to handle both analytical and manufacturing of DEA Scheduled products.
Xcelience, a contract drug manufacturer, announced that the company has received approval from the US Drug Enforcement Agency (DEA) to develop and manufacture Schedule I controlled substances. he license extension completes company’s approval to handle both analytical and manufacturing of DEA Scheduled products, according to a company statement.
"Regulatory capability is a critical attribute for CDMOs," says Alex McClung, vice-president, quality at Xcelience. "This Schedule I-V license underscores our capability and extends our Suite of Services to a whole new class of therapeutic compounds."
In addition, Xcelience announced that the company is expanding its pharmaceutical development services and manufacturing capacity by adding a new facility in the Tampa area to include more pharmaceutical development labs, manufacturing, quality assurance and packaging services.
Source: Xcellience
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