FDA Authorized Cantrell Drug Company Offers Significant Cost Savings for Sterile Injectable Drugs
James L. McCarley, Jr., Pharm.D. Chairman and CEO of Cantrell Drug Company, https://cantrelldrug.com, a 503B Registered Outsourcing Facility, announced that his Company is seeking to contract with a hospital group, purchasing organization or other pharmaceutical manufacturer to make one or more sterile injectable drugs that will provide significant cost savings.
Dr. McCarley commented: “In a 12-month period, we saved one hospital system over a million dollars on one line item. I invite anyone or any group in the hospital community who has a need for a sterile injectable compound(s) in annual volumes between 1M and 6M units to e-mail me directly at email@example.com.”
McCarley added that “as a result of unprecedented scrutiny, multiple inspections and review by the FDA, that ultimately resulted in our operating Consent Agreement with the Agency, we now have a best-in-class 503B Outsource Facility. Additionally, we have teamed up with a pharma research group for drug product development capabilities and advanced manufacturing. Regarding Quality Control, there is no one in the industry being held to any higher standard than those dictated by our consent agreement with the FDA. It is a tremendous insurance policy! We are in a prime position to partner with a hospital or purchasing group to make a few essential sterile injectable drugs that patients need—and provide those drugs on a reliable, significant cost saving basis. We just need some direction and commitment from the hospital community in regard to what needs to be produced.”
On September 21, John W. Diehl, M.S. Director, Compliance Branch of the FDA in Dallas wrote to Dr. McCarley confirming that Cantrell can produce and ship drugs under terms of the previous Consent Decree. Click here to read that letter.
Cantrell Drug Company, founded in 1952, has previously produced over 400 unique formulations of sterile injectables.
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