Saltigo builds in HPAPI manufacturing space for US and Japanese customers
The Frankfurt, Germany-based firm will add manufacturing capacity at its facility in Redmond in Washington State, US – specifically for the production of compounds classed as category III under the SafeBridge toxicity categorization system.
Andreas Stolle, head of the firm’s pharma business unit, said: "Once the expansion project has been completed, we will be able to respond even more extensively and flexibly to our customers` requirements.”
The US expansion, which is due to be completed in 2012, comes hot on the heels of Saltigo’s receipt of accreditation by Japanese regulators for its API and intermediates manufacturing site in Leverkusen, Germany.
The “Certificate of Foreign Drug Manufacturers" issued by the Japanese Ministry of Health, Labor and Welfare (MHLW) applies to all non-sterile APIs made at the plant and is very important to Saltigo’s expansion according to Stolle.
"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" he said.
Lanxess, Saltigo's parent company, was unable to provide further information ahead of publication.
