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Langenfeld, Germany, 2011/10/13 - A Globally Attractive Partner - Saltigo at CPhI 2011 in Frankfurt, October 25-27, Hall 4.2, Stand 42F03 - LANXESS.com.
Market position strengthened in both the United States and Japan
Custom and exclusive synthesis specialist Saltigo GmbH has underlined its intention to provide customers all over the world with optimal support with its custom manufacturing services. At the international trade show for pharmaceutical ingredients "CPhI Worldwide" taking place in Frankfurt, Germany, from October 25-27, 2011, Dr. Andreas Stolle, head of the Pharma business line at Saltigo, announced two important moves in the company's strategic alignment.
First, the company will build new production capacities for potent active pharmaceutical ingredients for the American pharmaceutical industry at its U.S. site in Redmond. Second, it is looking to strengthen its commitment in Japan, evidence of which is provided by the recent accreditation of Saltigo's Leverkusen site by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
Saltigo now also supplies potent APIs
Potent and highly potent active pharmaceutical ingredients (APIs) of Categories III and IV as defined by the SafeBridge® system already play a key role among the low-molecular-weight active ingredients. This trend will continue to increase in the future. Such substances can be administered in lower doses than other active ingredients and therefore generally cause fewer side-effects. On the other hand, their safe production and handling require specific precautions.
Dr. Stolle: "We have decided to expand the production capabilities at our Redmond site in the U.S. state of Washington so that we can also produce and handle highly effective Category III substances there." The respective capacities up to the kilogram range will become available at the beginning of 2012 and will provide Saltigo's customers with even more products and services from a single source. The company will then also be able to produce active ingredients with an OEL (Occupational Exposure Limit) of less than 10 micrograms per cubic meter of air. "Once the expansion project has been completed, we will be able to respond even more extensively and flexibly to our customers' requirements. The outstanding facilities we already have in Redmond will make it possible to carry out this expansion of our synthesizing services quickly and cost-effectively," said Stolle.
Saltigo's expertise covers all the development stages for APIs, from the preclinical phase to the product's manufacture after-market launch. The CGMP-qualified production plants in Redmond are specifically oriented to the requirements during phases 1 and 2.
Accreditation by Japanese supervisory authority
It is not only on the U.S. west coast that major pharmaceutical and chemical companies are based. There are many more on the other side of the Pacific Ocean, in Japan. To enable Saltigo to serve as an efficient partner to these companies too, it decided to apply for certification of its production facilities by the Japanese accreditation authority PMDA. The Leverkusen site was duly accredited a short time ago. The "Accreditation Certificate of Foreign Drug Manufacturers" from the Japanese Ministry of Health, Labor and Welfare (MHLW) applies to all non-sterile active ingredients. Andreas Stolle cannot emphasize the importance of this accreditation enough: "For us, its value is similar to that of a certificate from the US Food and Drug Administration (FDA). It is an essential milestone for further expanding our business activity in Japan and safeguarding it on a sustainable basis." Cooperation agreements with Japanese companies will in the future become even more important for Saltigo. In addition, through the accreditation, Saltigo has qualified itself as a manufacturer of active ingredients to be exported to Japan and designated for the market there.
Saltigo GmbH is a leading supplier in the field of custom synthesis. The company of specialty chemicals group LANXESS belongs to the Advanced Intermediates segment, which achieved total sales in 2010 of EUR 1,321million. Saltigo, headquartered in Langenfeld and with production facilities in Leverkusen and Dormagen, employs around 1,400 staff worldwide. LANXESS Corporation (lanxess.com) operates a site for Saltigo in Redmond (Washington, United States).