Compliance

DSM Anti-Infectives is aware that it has a great responsibility towards its customers and the end-users of its products. In order to secure our products we have placed Quality Management on the top of our priority list. To ensure our compliance we have developed a quality management system based on the ICH Q7a guidelines; GMP for Active Pharmaceutical Ingredients. This system is combined with the strong DSM Corporate guidelines for quality management.

The policies, related ISOPs, and local SOPs from our quality management system ensure that all DSM Anti-Infectives’ products meet the cGMP requirements and assure the quality, safety and efficacy of our APIs that are used by our customer and in the preparation of Medicinal Products in all markets. This system is supported by quality targets and key performance indicators to measure and monitor our performance in our daily business and manufacturing operations.

Some facts:

• All DAI Manufacturing Sites have a current GMP Certificate from their National Health Authority Inspectorate.

• Four DAI API Manufacturing Sites are already FDA Approved -Sweden (Clavulanic Acid), Chemferm (Cephalexin and Cefadroxil), FGb Mexico (Penicillin GK, Amoxicillin, Ampicillin) and Capua (Nystatin).

• Two more - Deretil, Spain and Toansa, India (both for Purimox -Enzymatic Amoxicillin- are preparing for FDA Inspection)

• All of our sites regularly receive and pass Customer Audits. 18 Customer audits were received in 2006. Any improvements identified by our customers auditors are welcomed and actions are implemented to improve further our Quality Compliance Level

• The GMP requirements increase depending on the material manufactured in the following order: 1) Enzymes, 2) Registered Starting Materials, 3) intermediates, 4) APIs