Major US approval for pharma business
SCM Pharma’s Prudhoe-based pharmaceutical contract manufacturing facility has been approved at the first attempt by the US the Food and Drug Administration (FDA).
The FDA is responsible for the regulation and supervision of pharmaceuticals in the US. The thumbs up from the US regulator potentially opens up huge opportunities for the company in the production of commercial medicines in the US as to date it has been limited to making drugs for the clinical trial market.
The approval came following a week-long detailed inspection of SCM Pharma’s clinical development and manufacturing site. This was triggered after it was named as a one of the commercial suppliers for a new varicose veins treatment that has now been given the official go-ahead in the US.
It is a massive boost to the award-winning sterile manufacturing business as the launch of its clients’ new medication comes after SCM Pharma has provided clinical development consultancy for the product for around eight years.
SCM Pharma’s 110-strong team specialise in the sterile production of products for clinical trials and the supply of licensed drugs in niche commercial markets. It recently opened the doors of a new £6m site in Newburn, which complements its now FDA-approved clinical manufacturing facility nearby.
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.
“As we move into our tenth year in business, 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.
“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,” added Dianne.
Independently-owned, 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.
This was posted in Bdaily's Members' News section by Holli Brown .