Cantrell Drug Company, a 503B Registered Outsourcing Facility, announced that the company has received final approval from the FDA to begin producing and shipping product under the terms and conditions of a Consent Decree Agreement with the FDA that was signed on April 19th of this year.
“Patient safety is Cantrell Drug’s number one priority. Cantrell has been through the most robust of federal and independent reviews,” Dr. James L. McCarley, Jr., Chairman and CEO of Cantrell Drug Company said. “The FDA’s approval means our facilities, equipment, and processes meet current Good Manufacturing Practice standards. We wholeheartedly share the FDA’s objective to ensure our drugs are safe and effective. We are readier than ever before to supply patients with quality medications!”
Dr. McCarley said that Cantrell Drug will resume operations by producing two drugs that are in critically short supply: Morphine Sulfate 2mg/ml Injection Solution 1ml Syringe and Hydromorphone 1mg/ml 1ml fill BD 3ml Syringe.
Cantrell Drug Company, founded in 1962, provides sterile injectable pharmaceuticals that are primarily used in hospital operating room suites.