The UK-based contract manufacturing organisation (CMO) will be responsible for the filling of the 2ml and 10ml vial presentations, sterilisation, finished product testing and supply of the product.

Ketensin is indicated for the treatment of hypertensive crisis during and after surgery, and is marketed by ProStrakan in the Netherlands. As a niche product, it requires relatively limited supply. The market demand is an ideal match for SCM Pharma, which looks after the low volume licensed product supply needs of several specialty pharmaceutical firms across Europe.

David Traynor, senior VP manufacturing and pharmaceutical sciences at ProStrakan, said: "With regular demand for Ketensin in the Netherlands, we required a manufacturing partner that could not only sterile fill into various sizes of vials and test the finished products, but that could reliably deal with smaller commercial quantities.

"Having completed the technical transfer and geared-up for the Process Qualification batch already, we have been impressed by the customer interaction, willingness and technical ability demonstrated by SCM Pharma and look forward to working with the team on an ongoing basis."

Working with one of Europe’s fastest growing pharmaceutical companies is a major coup for sterile manufacturing specialist SCM Pharma. The Galashiels pharmaceuticals firm recently announced it had received FDA approval in the US for both its breakthrough cancer pain product Abstral and testosterone gel FORTESTA.

With its headquarters in Scotland, ProStrakan develops and commercialises medicines for the treatment of unmet therapeutic needs, which fits well with SCM Pharma’s expertise of delivering novel, difficult and dangerous finished drug products.

Dianne Sharp, managing director at SCM Pharma, said: "We are delighted to have secured a long-term deal with such a fast-growing high-profile client and are looking forward to meeting ProStrakan’s supply needs for Ketensin over the next few years and beyond.

"This type of product not only complements our core capability of filling and sterilising small batches of glass vials but also makes optimum use of the in-house microbiology, chemistry and sterility testing services that our facility offers clients."

This contract-win follows the opening of SCM Pharma’s first US office at the end of last year to further boost the company’s growing export revenue and better service US-based clients.

The company commands a unique position in the CMO market with its ability to sterile fill finish C14 radio-labelled compounds to GMP standards and produce highly potent products such as cytotoxics for both clinical trials supply and the small volume supply of licensed commercial products.

The CMO offers sterile and non-sterile production services to pharmaceutical, biotech and medical device companies across the world and is able to fill ampoules, vials, syringes, devices and cartridges.

Along with a client portfolio featuring several specialty pharmaceutical companies, the CMO has now worked with a third of top ten big pharma on various product indications across a number of therapeutic areas.

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