FDA approval for manufacturing at Dales Pharmaceuticals
Now looking to extend FDA approval to other products and dosage forms
Dales Pharmaceuticals, based in Skipton, North Yorkshire, UK, the manufacturing business of Dechra Pharmaceuticals PLC, has been approved by the Food and Drug Administration to produce Vetoryl 120mg capsules for the US market.
‘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,’ said Mike Annice, managing director, Dales Pharmaceuticals. ‘I would like to thank all the staff for their contribution to this achievement.
‘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.’
Dales’ quality director, Andrew Parkinson, added: ‘This is the culmination of a project that has involved significant investment in the quality systems and infrastructure at the Skipton facility.’
The approval complements Dales’ existing licences and the company is now able to produce pharmaceutical products for all major world markets.