Frontage Receives Approval for Manufacture of Schedule I and II Drug Products
News Dec 24, 2013
Frontage has announced that its CMC Services group has received approval from the Drug Enforcement Agency (DEA), a United States federal law enforcement agency under the U.S. Department of Justice, for manufacture of Schedule I and II drug products, expanding Frontage’s handling capabilities to all pharmaceutically relevant classes (Schedules I - V) regulated by the DEA.
The approval enables Frontage to conduct formulation development and Good Manufacturing Practices (GMP) manufacturing projects for many key medications used to treat pain and central nervous system (CNS) conditions.
Frontage provides organic synthesis, formulation development, GMP analytical testing, GMP clinical trial material manufacturing, clinical trial services and bioanalytical support of clinical and preclinical studies for all types of drug candidates ranging from novel, early phase projects to generic-equivalent and consumer care medications.
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.
Dr. Wang continued, “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.”
Frontage’s relevant experience ranges from conducting abuse deterrence studies (both clinically and analytically) and product development support for several different classes of pain relievers, including opioid compounds such as morphine, oxycodone, oxymorphone, hydromorphone and fentanyl, to non-steroidal anti-inflammatory compounds such as tramadol, naproxen sodium, ketoprofen, ibuprofen, and piroxicam, to anti-convulsant medications used as pain treatments, such as pregabalin, phenobarbital, midazolam, and oxcarbazepine.
Frontage helps biopharmaceutical organizations advance their research and development efforts with full service offerings- including bioanalysis, preclinical and clinical studies, analytical testing and product development support- spanning discovery stages through late-stage clinical trials.
The company also provides turnkey product development, bioequivalence and analytical services to generic and consumer health pharmaceutical companies to support Abbreviated NDA and 505.b.2 application submissions.
With a 12-year history of bioanalytical, clinical research and CMC operations, eight research facilities and more than 300 professionals in the US and China, Frontage has enabled biopharmaceutical and generic companies of all sizes to advance hundreds of molecules through clinical development and commercial launch in global markets.