Dechra Pharmaceuticals PLC FDA Approval for manufacturing at Dales Pharmaceuticals
pharmafile | December 9, 2011 | News story | Manufacturing and Production, Research and Development | FDA Approval
Dechra® Pharmaceuticals PLC
FDA APPROVAL FOR MANUFACTURING AT
DALES® PHARMACEUTICALS
Dales Pharmaceuticals (‘Dales’ or the ‘Company’), based in Skipton, North Yorkshire, UK, the manufacturing business of Dechra Pharmaceuticals PLC (“Dechra”), has been approved by the Food and Drug Administration (‘FDA’) to produce Vetoryl 120mg capsules for the US market.
Mike Annice, Managing Director, Dales Pharmaceuticals said:
“I would like to thank all the staff for their contribution to this achievement. 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.”
Dales’ Quality Director, Andrew Parkinson, added:
“This is the culmination of a project which has involved significant investment in the quality systems and infrastructure at the Skipton facility.”
The approval complements Dales’ existing licenses and the Company is now able to produce pharmaceutical products for all major world markets.
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Enquiries: |
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Mike Annice, Managing Director |
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Gareth Davies, Sales & Marketing Director |
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Dales Pharmaceuticals |
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Tel: +44 (0) 1756 791311 |
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Trademarks appear throughout this release in italics. Dechra and the Dechra ‘D’ logo are registered Trademarks of Dechra Pharmaceuticals PLC.
Editors Notes:
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, is located in Skipton, Yorkshire; it employs over 200 staff and is an MHRA approved licensed pharmaceutical manufacturer with multi-competence in both scale and dose for both veterinary and human pharmaceuticals. It produces the vast majority of Dechra’s own branded licensed products marketed through Dechra Veterinary Products (DVP); approximately 50% of its production is utilised in the manufacture of products for third parties which are used in human healthcare. www.dalespharma.com
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