We provide industry-leading production know-how and comprehensive regulatory support for high-quality active pharmaceutical ingredients (APIs), backed by nearly 200 years of experience. Our commercial and late-stage APIs, as well as advanced intermediates, are primarily manufactured and purified at our cGMP site in Arklow, Ireland. The 64,000-square-meter facility includes extensive processing equipment, milling capability, testing laboratories, and state-of-the-art fractional distillation equipment. We have the resources and technical expertise to support you with new process evaluation, product registration and filing, process development and validation, technology transfer, reference standard synthesis, and regulatory filing support.
From our complete portfolio of innovative folates to custom synthesis, you will find the customized and scalable solutions you need to meet specific production requirements. The following products are manufactured at the Arklow facility, available for immediate shipment globally:
We also offer a comprehensive selection of high-quality reduced folates for pharmaceutical and nutritional applications. Our high-quality “nature identical” folates for nutritional and pharmaceutical applications include Metafolin® and Arcofolin®. Both are based on the stable crystalline form of L-methylfolate, the naturally occurring, primary biologically active form of folate. Other reduced folate offerings include Calcium Folinate and Levofolinate Pentahydrate.
When you need high-quality raw materials for use as active pharmaceutical ingredients, we provide customized and scalable solutions that meet specific production requirements, backed by excellent production know-how and comprehensive regulatory support. Our state-of-the-art production sites comply with cGMP standards and have a spotless FDA track record with no findings. To simplify your compliance requirements, the following products have obtained Rx-360 audits:
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