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12/3/2013 9:06:43 AM
December 2013 -- SCM Pharma’s UK-based clinical development and manufacturing facility has been approved at the first attempt by the US the Food and Drug Administration (FDA).
The inspection at the contract development and manufacturing organisation (CDMO) was triggered by the company supporting British 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.
This gives the CDMO’s Prudhoe site the official thumbs up from US regulators following an inspection in November after it was named on the New Drug Application (NDA) as a 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 production of products for clinical trials and the supply of licensed drugs in niche commercial markets. It recently opened the doors of a new $10m site, 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.
The award-winning CDMO 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 news is a much-needed boost to the global sterile production market following the issuing of many warning letters by the US FDA, the closure of other sites and supply shortages due to production being halted at some CMO facilities.
Independently-owned, most of SCM Pharma’s clients’ projects involve the aseptic filling and terminal sterilisation of liquids and powders into vials, ampoules and syringes.
In a bold move, the CDMO recently used CPhI in Frankfurt as a platform to offer pharmaceutical companies across the world the opportunity to design their clinical and contract manufacturing projects from a ‘blank canvas’ of cleanroom space.
In contrast to contract manufacturers, SCM Pharma is inviting drug developers and licensed product owners the opportunity to utilise dedicated space at its new site to design a process around their specific product manufacturing needs.
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