FDA Approval for Manufacturing at Dales
Issued by Citigate Dewe Rogerson Ltd, Birmingham
Date: Tuesday, 29 November 2011
Dechra® Pharmaceuticals PLC
FDA APPROVAL FOR MANUFACTURING AT
DALES® PHARMACEUTICALS
International veterinary pharmaceuticals business, Dechra Pharmaceuticals PLC ("Dechra") is pleased to report that, following submission to the US Food and Drug Administration (FDA) in 2010 and subsequent final inspection in September 2011, its wholly owned subsidiary and licensed manufacturer of pharmaceuticals Dales, has been granted full FDA approval to manufacture a line extension for Vetoryl 120mg capsules which are to be marketed and sold in the US market.
Ian Page Chief Executive, Dechra commented:
"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.
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Enquiries: |
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Ian Page, Chief Executive |
Fiona Tooley, Director |
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Simon Evans, Group Finance Director |
Keith Gabriel, Senior Account Manager |
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Dechra Pharmaceuticals PLC |
Citigate Dewe Rogerson |
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Tel: +44 (0)1782 771100 |
Tel: +44 (0) 121 362 4035 |
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Mobile: + 44 (0)7775 642222 (IP) or + 44 (0)7775 642220 (SE) |
Mobile: + 44 (0)7785 703523 (FMT) |
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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
This information is provided by RNS
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