PET drugs company Dechra Pharmaceuticals has won US regulatory approval for its Dales factory in Skipton.
The plant can now make Vetoryl 120mg capsules, used to treat Cushings disease, for the huge US market.
Dechra made its submission to the US Food and Drug Administration (FDA) in 2010 and Dales had a subsequent final inspection in September.
Mike Annice, Dales’ managing director, said: “This is the culmination of a project which has involved significant investment in the quality systems and infrastructure at the Skipton facil- ity.”
Dechra’s chief executive Ian Page 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.”
The US has huge potential for Dechra.
While there are about eight million dogs, eight million cats and a million horses in the UK, there are 75 million dogs, 82 million cats and 10 million horses in the US.
The approval complements Dales’ existing licenses and the company will now able to produce pharmaceutical products for all major world markets.
Analyst Brian White at Shore Capital said: The achievement of an FDA approved manufacturing facility is a significant achievement for Dechra and should go some way to further the company’s aspirations in this key geography.
“Currently, Vetoryl is the most important product for Dechra in the US.”
Dechra has managed to beat the economic downturn thanks to strong sales of its branded products.
The group said that sales of its branded products helped to boost profits by 15 per cent in the year to June 30.
Mr Page said: “Although footfall through veterinary practices has declined and the general economic climate remains uncertain we are continuing to demonstrate solid growth in markets in which we trade.
“Our branded product range, the focus of our key strategic objective, continues to grow strongly.”
The company, which develops prescription medicines for dogs, cats and horses, therapeutic diets for dogs and cats, and unlicensed medicines, shampoos and supplements, posted an underlying pre-tax profit of £30.1m in the year to June 30.
Revenues were 5.4 per cent higher at £389.2m.
Dechra is developing a number of new drugs for launch in 2013.