About the Site:

The Cramlington site, near Newcastle, UK, has an established history of cGMP manufacturing services for an array of API, ranging from pilot scale to commercial metric ton scale. The site has more than 100 cubic metre reactor commercial capacity and has been inspected and approved by the MHRA, FDA and other regulatory authorities. The site can commercialise product from 10L to 10,000L scale.

Site Summary:

• Vertical integration into Pharmaron CMC network
• Regulatory track record – MHRA, FDA, EMA, PDMA
• Available capacity – 100,000L of vessel and isolation equipment
• Controlled drug licence – all schedules
• OEB 4 containment 
• In-house analytical and QC capability (expanding)
• Close links with Late Phase and R&D teams and capability