compiled by Angela Godwin

DSM sells pharmaceutical production site

DSM Pharmaceutical Products, a Business Group of Royal DSM NV, has signed an agreement with Albemarle Corporation of Baton Rouge regarding the sale of the assets and business associated with DSM’s pharmaceutical production site in South Haven, MI., which is focused on the production of generic active pharmaceutical ingredients (APIs). “We are very pleased that through the transaction with Albemarle we have been able to secure the future of the site and to safeguard the employment of more than 100 of our people in South Haven”, says Leendert Staal, President of DSM Pharmaceutical Products. Terms of the deal were not disclosed.

Guidelines for modern ization of drug manufacturing

Last month, the Food and Drug Administration (FDA) issued a final guidance on quality systems, a set of formalized practices and procedures to ensure quality of human and veterinary drugs and human biological drug products during manufacturing. The guidance enhances FDA’s cGMP regulations. The document, “Quality Systems Approaches to Pharmaceutical Current Good Manufacturing Practice (cGMP) Regulations,” is expected to help manufacturers maintain consistent high quality and improve efficiency. It aims to demonstrate the benefits of incorporating modern quality principles-which should foster technical advancements-into manufacturing processes to better ensure the safety and efficacy of drugs for people and animals. Another goal of the guidance is to increase drug-production efficiency, which should help lower costs and prevent shortages of critical medicines due to manufacturing failures that can result in production stoppages and recalls. The full text of the guidance can be found at www.fda.gov/cder/guidance/7260fnl.htm.