At the CPhI Worldwide 2004 show in Brussels, Belgium, Cognis’ Pharmaceuticals & Healthcare business unit presented its current portfolio of products developed especially to meet the stringent regulatory requirements confronting today’s pharmaceutical industry. These include its PharmaLine™ range of premium-quality oleochemical-derived excipients.

In recent years, the regulatory obligations placed on the pharmaceutical industry have continued to increase. As a result, the requirements made of chemical suppliers, including excipient manufacturers, are becoming more stringent. To meet the specific needs, Cognis has launched a range of products which satisfy the most stringent requirements and comply with the latest pharmacopoeias, under the name of PharmaLine. Integrated ISO 9001 and ISO 14001 management systems, a clearly defined manufacturing process, and a system for monitoring compliance with the relevant Good Manufacturing Practice (GMP) guideline according to the International Pharmaceutical Excipients Council (IPEC) all help to enhance that the process standards are observed. This quality system helps customers to expedite the process of licensing new products with the relevant authorities, by ensuring all the necessary documentation is already in place.

Every manufacturing batch is subjected to an analysis based on the relevant monographs. Additionally, drug master files (type IV) and extensive purity data, with particular attention being paid to levels of heavy metals, aflatoxins, polycyclic aromatics, hydrocarbons and microbiology, are available. The PharmaLine products are premium-quality oleochemical-derived excipients such as specialty esters, fatty alcohols, ethoxylates, hard fats, stearic acids, mono- and triglycerides and castor oil derivates. They are used by pharmaceutical companies in topical, oral, parenteral and other pharmaceutical formulations, as tabletting aids, solubilizers, consistency factors, emulsifiers, emollients, cream bases, and suppository masses for solid, semi-solid and liquid pharmaceutical dosage forms. Cognis is committed to the constant expansion of the PharmaLine range to move with its customers’ changing requirements, and is also cooperating with its customers in the pharmaceutical industry to find customized products and solutions.

"In a highly regulated market, it is vital that customers are able to validate their suppliers,” says Albert Strube, Global Market Segment Manager Pharmaceuticals & Healthcare. “Multinational pharmaceutical customers rightly expect outstanding service, and this includes suppliers being able to provide documentary evidence of their own risk management systems. Our approach is always to help our customers meet their regulatory obligations, so they can succeed in their markets."

About Cognis:
Cognis is a worldwide supplier of innovative specialty chemicals and nutritional ingredients. As at September 30, 2004, the company employed about 8,100 people, and it operates production sites and service centers in 30 countries. Cognis has dedicated its activities to a high level of sustainability and delivers natural source raw materials and ingredients for food, nutrition and healthcare markets, and the cosmetics, detergents and cleaners industries. Additionally, Cognis provides solutions for a number of other industries, such as coatings and inks, lubricants, textiles and plastics, as well as agriculture and mining.

Cognis is owned by private equity funds advised by Permira, GS Capital Partners, and Schroder Ventures Life Sciences. In 2003, Cognis recorded sales of 2.95 billion euros and an operating profit before depreciation, amortization and exceptional items (EBITDA recurring) of 312 million euros.

Contact:
Dr. Albert Strube, Market Segment Manager Pharmaceuticals & Healthcare
Cognis Deutschland GmbH & Co. KG
Phone: +49-211-7940-2745
E-mail: albert.strube@cognis.com
Internet: www.cognis.com

Andrea Pitrella, Marketing Manager Pharmaceuticals & Healthcare
Cognis Deutschland GmbH & Co. KG
Phone: +49-211-7940-8529
E-mail: andrea.pitrella@cognis.com
Internet: www.cognis.com