CoreRx Inc. receives approval for Schedule I controlled drug manufacture

CoreRx Inc. receives approval for Schedule I controlled drug manufacture

Approval now extends ability to develop and manufacture all scheduled drug classifications

CLEARWATER, FL, April 30, 2021, CoreRx, Inc., is pleased to announce that they have received approval from the Federal Drug Enforcement Agency (DEA) to develop and manufacture Schedule I controlled substances in their facilities. Schedule I substances are “considered the most dangerous class of drugs,” according to the DEA website. CoreRx has a long track record of working with DEA controlled substances, and this license extension completes their approval to now handle both analytical and manufacturing of the full spectrum of DEA Scheduled products. This approval further underscores CoreRx as the premier Contract Development and Manufacturing Organization for supporting development and manufacturing of clinical and commercial drug products, including all of industry’s Scheduled product needs.

“There continues to be increasing interest and research by pharmaceutical and biotech companies in exploring potential therapeutic indications for current Schedule I drug substances”, says Mark DaFonseca, Chief Business Officer for CoreRx. “For example, Cannabidiol (CBD) drug development has exploded over the past few years, and this license now provides CoreRx the ability to support these clients throughout the drug development continuum in conducting this important area of research. This expansion of our Scheduled products’ license is just another example of our continued investment in broadening our capabilities to offer clients more end to end solutions to solve their drug development needs.” This news follows previous announcements at CoreRx around the expansion of the organization, which included a new 26,000 square foot Product Development Center of Excellence, as well as added manufacturing and testing infrastructure into its 155,000 square foot ICOT center campus in Clearwater, FL.


About CoreRx, Inc.

CoreRx, a Contract Development Manufacturing Organization (CDMO) with capabilities to support clinical – commercial manufacturing, offering state of the art facilities to support your supply chain needs. Our integrated offerings provide comprehensive services for the development, manufacturing, and testing of solid, liquid and semi-solid dosage forms.

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