Drugs company SCM Pharma is poised to produce commercial medicines for the US after its Northumberland manufacturing facility was approved at the first attempt by the US Food and Drug Administration (FDA).
Founded in 2004, the business specialises in the sterile production of drugs destined for clinical trials, along with licensed medicines required by patients in niche markets.
Yet the green light from the FDA – responsible for the regulation and supervision of all pharmaceuticals in the US – opens up huge possibilities 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 comes after a week-long detailed inspection of SCM Pharma’s clinical development and manufacturing site in Prudhoe, triggered after it was named as one of the commercial suppliers for a new varicose veins treatment that has now been given the official go-ahead in the US.
The company is supporting specialist healthcare company BTG, headquartered in London, in preparation for the commercial launch of Varithen, having provided clinical development consultancy for the product for around eight years.
The varicose veins treatment uses an injectable foam to dissolve the veins as an alternative to surgical removal.
SCM Pharma, which employs around 110 people, 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,”
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.
The firm demerged from Northumberland’s Specials Laboratory in 2008 and has focused on building its business from supplying clinics with bespoke medicines to winning contracts with larger drugs firms all over the globe.
In 2011, it opened an office in the US and a formulation facility at Sunderland University.