SCM Pharma’s clinical development and manufacturing facility in Prudhoe, UK, has been approved by the FDA. The inspection was triggered by the preparation for the commercial launch of BTG’s Varithena (polidocanol injectable foam), following clinical development consultation for the product.
The FDA has 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 surgery. SCM’s Prudhoe site was named on the NDA as a one of the commercial suppliers for the product. SCM Pharma has worked with BTG since 2005 on process development, sterile manufacturing, packaging and distribution to support clinical trial studies in the U.S.
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 license for our new commercial manufacturing facility in Newburn in the summer. This approval represents another major project where we have played a major developmental and production role to take a client with a complex product from early phase trials to commercial. We will be looking to immediately strengthen our U.S. team and presence as this approval will no doubt trigger more demand for our small-scale clinical and contract manufacturing services in North America.”