Pharmatek Laboratories, Inc., a premier contract development and manufacturing organization supporting the pharmaceutical industry, announced that it has been approved by the United States Drug Enforcement Agency (DEA) for the analysis of Schedules I through V controlled substances, complementing its existing license to develop and manufacture drug products containing Schedules IV and V controlled substances.
“Receipt of this additional registration from the DEA demonstrates that we meet the Agency's stringent requirements, and further validates our facility design, security systems, and procedures for analysis, handling, storage and disposal of controlled substances,” said Jeffrey Bibbs, PhD, CEO and CSO at Pharmatek. “This registration allows us to perform analytical and stability testing for all controlled-substance drug products within both our non-potent and highly-potent GMP facilities.”
Controlled substances are designated as schedule I-V according to their medical use, potential for abuse and safety or dependence liability. In order to research, manufacture or distribute a controlled substance, a person or entity must be audited and registered by the DEA.
“The DEA registration is another example of our efforts for continuous improvement and expansion of Pharmatek's services,” said Timothy Scott, President at Pharmatek. “As a client-centric organization, our success is predicated on our ability to serve our clients' evolving needs. We are happy to bring this additional capability to Pharmatek in order to serve that purpose.”
Pharmatek Laboratories, Inc. is a premier pharmaceutical chemistry development company providing full-service pharmaceutical chemistry product development for the pharmaceutical industry and focuses on bringing client compounds from discovery to the clinic with services that include compound selection, analytical development, pre-formulation testing, formulation development, GMP manufacturing, stability storage and testing, and cytotoxic and high-potency development and manufacturing.