SCM's Prudhoe facility gains FDA approval

UK CDMO supports BTG for commercial launch of varicose veins treatment

SCM Pharma’s UK-based clinical development and manufacturing facility in Prudhoe, Northumberland has received an official thumbs up from the US Food and Drug Administration (FDA).

The FDA inspection at the contract development and manufacturing organisation (CDMO) was triggered by the company supporting UK specialist healthcare company BTG in preparation for the commercial launch of Varithena (polidocanol injectable foam), after providing clinical development consultancy for the product for several years.

The FDA has now approved BTG’s varicose veins treatment (previously known as Varisolve PEM), which uses an injectable, pharmaceutical-grade foam to dissolve the veins as an alternative to surgical removal.

The US regulator inspected SCM's facility in November after the firm was named on the New Drug Application (NDA) as one of the commercial suppliers for the product.

SCM Pharma has worked with BTG since 2005, assisting with process development, sterile manufacturing, packaging and distribution to support clinical trial studies in the US. It specialises in the sterile manufacture of products for clinical trials and the supply of licensed drugs in niche commercial markets.

The FDA approval at our headquarters in Prudhoe tops off a milestone year for our business

Dianne Sharp, Managing Director at SCM Pharma, said: 'The FDA approval at our headquarters in Prudhoe tops off a milestone year for our business after gaining our MHRA licence for our new commercial manufacturing facility in Newburn in the summer.

'As we move into our tenth year in business, this approval represents another major project where we have played an important developmental and production role to take a client with a complex product from early phase trials to commercial. This is something I am extremely proud of and is testament to our technical, quality and production teams.'

Sharp added: 'We will be looking immediately to strengthen our US team and presence as this approval will no doubt trigger more demand for our small-scale clinical and contract manufacturing services in North America.'

SCM Pharma already works with several companies in the US and has built its reputation around the sterile filling of novel products, difficult processes and applications and dangerous substances such as potent products requiring high containment.

Companies