East Rutherford, NJ – Cambrex Corporation (NYSE: CBM, “Cambrex”) is pleased to announce that the development and validation of Sufentanil and Sufentanil Citrate have been completed and beginning in February 2012, Cambrex will begin supplying commercial quantities of each product to the marketplace. Further, Cambrex has the capability to supply micronized Sufentanil Citrate. Cambrex’s Charles City (Iowa) facility validated the production for Sufentanil base and completed the validation production of Sufentanil Citrate in late 2011.
“The development and validation of Sufentanil and Sufentanil Citrate was a natural extension of Cambrex’s high potency and controlled substance manufacturing capabilities at our Charles City facility,” commented Dr. Kurt Kiewel, Director of Chemical Development at Cambrex Charles City. “The process was based on our patented technology which allows straightforward access to all of the Fentanyl derivatives.” Cambrex has been manufacturing Fentanyl for the worldwide pharmaceutical market since 2006.
The process development and validation were performed in the High Potency Development Center at Cambrex Charles City. As Sufentanil has approximately 1000 times the potency of morphine and 5 to 10 times the potency of Fentanyl, containment and isolation were extremely critical for workers’ safety. The High Potency Development Center is a dedicated, controlled-access chemical and analytical lab suite with barrier isolation technology capable of safely manufacturing materials classified as Exposure Control Band (ECB) 4, the most potent materials. Validated cleaning methods were developed to detect very low levels of Sufentanil, ensuring the prevention of cross contamination with other products.
Sufentanil and Sufentanil Citrate meet the specifications of the US and European Pharmacopeias. Cambrex has the capacity to produce the total aggregate quota of Sufentanil and Sufentanil Citrate for the US market. Cambrex has US Drug Enforcement Agency (DEA) licensure for the research, development and manufacture of Schedule I-IV Controlled Substances.