Resolution to FDA Warning Letter

RNS Number : 0738G

Hikma Pharmaceuticals Plc

18 November 2015

 



Hikma announces successful resolution to FDA Warning Letter at its Portugal facility

London, 18 November 2015 - Hikma Pharmaceuticals PLC ("Hikma") (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody's / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, today announces that it has received a letter from the US Food and Drug Administration ("US FDA") closing out the Warning Letter it received in October 2014 in respect of its injectables manufacturing plant in Portugal.  This letter demonstrates that the corrective actions that were taken in response to the Warning Letter were fully reviewed and accepted by the US FDA.

Said Darwazah, Chairman and Chief Executive Officer of Hikma commented: "I am very pleased that we have brought our Portuguese facility back into compliance with the US FDA.  We have worked very hard to meet the FDA's requirements and remain committed to maintaining the highest standards of quality and compliance across all our facilities.  We believe that the resolution of the Warning Letter will enable us to accelerate the introduction of new products to the market, ensuring we continue to broaden the range of critical medicines we supply to patients in the US."

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Enquiries

Hikma Pharmaceuticals PLC                                                       

Susan Ringdal, VP Corporate Strategy and Investor Relations                   [phone]/ [phone]

Zeena Murad, Investor Relations Manager                                                        [phone]/ [phone]

FTI Consulting                                                                                  

Ben Atwell/ Matthew Cole                                                                                       [phone]

About Hikma

Hikma Pharmaceuticals PLC is a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded and non-branded generic and in-licensed products.  Hikma operates through three businesses: "Injectables", "Branded" and "Generics", based principally in the United States, the Middle East and North Africa ("MENA") and Europe.  In 2014, Hikma achieved revenues of $1,489 million and profit attributable to shareholders of $299 million. 

 

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