We provide MHRA and FDA licensed facilities for GMP synthesis services and the manufacturing of small scale APIs. While programs for phase I/II are supported from the UK, phase II-launch programs are supported from our pilot plant and commercial sites in India.
UK-based projects tend to be smaller scale but involve the rapid movement from non-GMP to GMP synthesis. Things won’t always go to plan at this stage but it’s how you deal with these issues that matter. So, if you’re after a nimble and flexible partner for API synthesis services that will help you overcome any teething problems, reduce your timelines and maximise efficiency, then get in touch today.
Our services include GMP synthesis, the manufacturing of small scale APIs, release and process validation. All services are delivered to European, US and Japanese standards and we have a proven record of reliably delivering clinical material production (over 60 individual APIs produced to GMP at small scale for clinical trials).
As part of our GMP synthesis services, our UK site is equipped with several GMP kilo laboratories including a class 100,000 clean room and a variety of vessel sizes up to 100 litres. At our India sites, we are equipped with non-GMP kilo laboratories with up to 65 litre reactors. Pilot plants with over 60 reactors from 100 – 1000 L are available and are equipped with molecular sieves and cryogenic conditions, to name just a few. We also have an independent quality assurance department and provide analytical support to all client projects.
If you’d like to know more about our GMP synthesis capabilities and our process for manufacturing small scale APIs or any of our contract research and manufacturing services, then please contact us today or view our API synthesis case study.