SCM Pharma has had its Prudhoe headquarters approved by the Food and Drug Administration (FDA), presenting the opportunity for the Northumberland-based company to expand further into the US.
The contract manufacturing facility was approved by the FDA on its first attempt and will allow SCM to expand from the US clinical trial market into the commercial medicine sector.
The inspection from the US regulator came after SCM was named as one of the commercial suppliers of a varicose vein treatment that is to be launched in North America.
SCM, which employs 110 members of staff, also opened its new £6m Newburn facility during the summer.
Dianne Sharp, managing director at SCM, said: “The FDA approval at our headquarters in Prudhoe tops off a milestone year for our business.
“As we move into our tenth year, 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.
“This is something I am extremely proud of and is testament to our brilliant technical, quality and production teams.”
Sharp added: “We will be looking to immediately 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.”