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Frontage Gains Schedule I-II Drug Approval from DEA



By Kristin Brooks



Published December 10, 2013
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Frontage’s CMC Services group has received approval from the Drug Enforcement Agency (DEA) for the manufacture of Schedule I and II drug products, expanding its handling capabilities to all pharmaceutically relevant classes (Schedules I – V) regulated by the DEA. The approval also allows the company to conduct formulation development and GMP manufacturing projects for key medications used to treat pain and central nervous system (CNS) conditions.
 
The DEA manufacturing license requires maintenance of a secure facility with precise monitoring and electronic access controls, specialized operating procedures, staff requirements and physical security.
 
“Together with our existing capabilities, technology and experience, this approval is significant in helping establish Frontage’s product development services as a center of excellence for pain management therapies,” said Dr. Dongmei Wang, general manager, CMC Services. “Pain adversely affects more than a billion people worldwide, and the science of pain management delivery keeps improving. We are committed to pursuing enhancements for effective and efficient development, as pain management products command a larger portion of our clients’ CNS pipelines.”


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