Dechra subsidiary boosted by US-agency approval for new drug
THE Yorkshire-based subsidiary of veterinary drugs supplier Dechra Pharmaceuticals is set to deliver a major boost to its Staffordshire parent after securing full licenses to produce a new product for the key US market.
Dales, based in Skipton, has been granted full approval by the US Food and Drug Administration to manufacture a line extension for Vetoryl 120mg capsules, which are to be marketed and sold in the US market.
The decision follows the original submission to the FDA in 2010 and a final inspection of facilities by the agency in September this year.
Vetoryl is a novel product for the treatment of Cushing’s syndrome (excess cortisol or hyperadrenocorticism) in dogs. It is marketed internationally and is the only recognised licensed efficacious veterinary product for the treatment of Cushing’s syndrome around the world.
Dales employs more than 200 staff and is an MHRA approved licensed pharmaceutical manufacturer. It produces the vast majority of Dechra’s own branded licensed products marketed through Dechra Veterinary Products (DVP); approximately 50% of its production is for the manufacture of products for third parties which are used in human healthcare.
Ian Page, Dechra chief executive, said: “The ability to produce Dechra’s leading product, Vetoryl, for the US market will result in medium term margin improvements for Dechra and a secure supply chain for this strategically important product.
“We will also be looking to extend the FDA approval into other products and dosage forms, this will open up further opportunities to both enhance the range of products sold in the US and add to our manufacturing capabilities provided to third-party customers.”
Mike Annice, managing director at Dales, added: “This is the culmination of a project which has involved significant investment in the quality systems and infrastructure at the Skipton facility. I would like to thank all the staff for their contribution to this achievement.”
The approval complements Dales’ existing licenses and the company is now able to produce pharmaceutical products for all major world markets.
