Onyx is now licensed to manufacture commercial API from our UK facility

CMC Services: Explore Our Facilities

As a small molecule CDMO, Onyx Scientific’s UK and US locations support customers with a range of integrated CMC services; from process R&D through to commercial API manufacturing. Bringing together our world-class chemists and industry know-how, we are addressing global small molecule API supply needs for even the most challenging compounds.

Sunderland, UK

Our UK facility spans over 3,000 square metres and is home to our MHRA-accredited laboratories for custom synthesis and process R&D, alongside our specialist 50 L kilo-laboratories (ISO 8) for GMP manufacture of Phase I to III clinical trial materials. The facility is also licensed for the manufacture of low volumes of small molecule commercial APIs and is particularly suitable for orphan drugs. This site also houses our dedicated solid state chemistry, analytical and stability testing facilities.

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North Carolina, US

For over 20 years, Onyx’s FDA-accredited pilot facility in the US has provided GMP manufacturing services across three multi-purpose GMP manufacturing suites up to 2,000 gallons / 8,000 litres. With R&D facilities situated alongside GMP analytical laboratories (including stability testing), we offer all the advantages of internal tech-transfer for gram quantity processes through scale-up to multi-ton commercial small molecule API manufacture.

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