CPhI NEWS: Saltigo strengthens market position in US and Japan

Published: 28-Oct-2011

HPAPI facilities in Redmond to be upgraded; and Leverkusen accredited by Japanese PMDA

Saltigo has announced two strategic developments that underline its intention to provide customers all over the world with optimal support.

First, the company is to upgrade production capacities for potent active pharmaceutical ingredients at its US site in Redmond, Washington. The move will enable manufacture of quantities from pre-clinical to Phase II, thus offering great flexibility to respond to increased demand. The new capability is expected to come on stream in the first quarter of 2012.

‘We have decided to expand the production capabilities at our Redmond site so that we can also produce and handle highly effective Category III substances there,’ said Dr Andreas Stolle, head of the Pharma business line. ‘The company will then also be able to produce active ingredients with an OEL (Occupational Exposure Limit) of less than 10µg per cubic metre of air.’

‘The outstanding facilities we already have in Redmond will make it possible to carry out this expansion of our synthesising services quickly and cost effectively,’ he added.

Saltigo is also looking to strengthen its commitment in Japan, and the company’s Leverkusen site was recently accredited by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The ‘Accreditation Certificate of Foreign Drug Manufacturers’ from the Japanese Ministry of Health, Labour and Welfare (MHLW) applies to all non-sterile active ingredients. ‘For us, its value is similar to that of a certificate from the US FDA,’ said Stolle. ‘It is an essential milestone for further expanding our business activity in Japan and safeguarding it on a sustainable basis.’

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