Portfolio APIs

We provide industry-leading production know-how and comprehensive regulatory support for high-quality APIs, backed by nearly 200 years of experience. From a complete portfolio of innovative folates to custom synthesis, our customized and scalable solutions meet your specific production needs.

Our high-quality “nature identical” folates for nutritional and pharmaceutical applications include Metafolin® and new Arcofolin™. Both are based on the stable crystalline form of L-methylfolate, the naturally occurring, primary biologically active form of folate.

Our 64,000 m2 site in Arklow, Ireland is our primary center for cGMP manufacturing and purification of commercial and late-stage APIs and advanced intermediates. The site includes extensive processing equipment and state-of-the-art fractional distillation equipment. Our team supports customers with expertise in new process evaluation, process development and validation, technology transfer, reference standard synthesis and regulatory filing support.

The following items are manufactured at the Arklow facility and available for immediate shipment globally.

Product Name Product Code Compliance
Acepromazine Maleate ARK2015 • CTD and US DMF available
Brompheniramine Maleate ARK2055 • Conforms to the USP, EP and BP specifications
• CTD and US DMF available
Clomipramine Hydrochloride ARK2091 • Conforms to the USP, EP and BP specifications
Doxylamine Succinate ARK2009 • Conforms to the USP, EP and BP specifications
• Certificate of Suitability (COS) and US DMF available
Doxylamine Succinate milled ARK2144 • Conforms to the USP, EP and BP specifications
• Certificate of Suitability (COS) and US DMF available
Lofepramine Hydrochloride ARK2064 • Conforms to EP and BP specifications
• CTD available
Nortriptyline Hydrochloride ARK2086 • Conforms to the USP, EP and BP specifications
• CTD and US DMF available
Promethazine Hydrochloride ARK2062 • Conforms to the USP, EP and BP specifications
• CTD and US DMF available