
PTSM: Pharmaceutical Technology Sourcing and Management
- PTSM: Pharmaceutical Technology Sourcing and Management-04-01-2015
- Volume 11
- Issue 4
Xcelience Receives DEA Approval for Schedule I Drug Products
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:
Articles in this issue
over 10 years ago
Standard for Excipient GMPs Reflects Industry Consensusover 10 years ago
TraceLink Joins PBOAover 10 years ago
Serialization Success Depends on Integrated Equipment and Systemsover 10 years ago
Risk-based Strategies to Prevent Drug Shortagesover 10 years ago
Shifting Biopharma Strategies Shape Outsourcing Marketover 10 years ago
Temperature-controlled Logistics Address Cold-Chain Challengesover 10 years ago
Who Will Staff Expanding CMO Operations?over 10 years ago
Kemwell’s Bangalore Facility Completes Successful FDA Inspectionover 10 years ago
Recipharm Delivers Serialization Solutions for Abbott in Koreaover 10 years ago
Laurus Synthesis Launches New Facility in Woburn, MANewsletter
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