Hikma announces receipt of Warning Letter from FDA

RNS Number : 1798V

Hikma Pharmaceuticals Plc

24 October 2014

 



London, 24 October 2014 - Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing multinational pharmaceutical group, announces that it received a Warning Letter from the U.S. Food and Drug Administration ("FDA") on 23 October 2014 related to the inspection of its manufacturing facility in Portugal in March 2014.

In the letter, the agency raised issues related to investigations and environmental monitoring at the facility. Hikma takes this matter very seriously and will work with the FDA to fully resolve all outstanding issues.

At this point, Hikma does not anticipate that the warning letter will impact the manufacturing or distribution of the products manufactured in its Portugal facility, and does not believe that it will impact its financial guidance for 2014.

Hikma remains committed to the highest standards of quality and compliance across its 27 manufacturing facilities in 11 countries.

Hikma will provide further updates in due course.

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Enquiries

Hikma Pharmaceuticals PLC                                                       

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

Lucinda Baker, Deputy Head of Investor Relations                            [phone]/ [phone]

FTI Consulting                                                                                  

Ben Atwell/ Matthew Cole/ Julia Phillips                                              [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: "Branded", "Injectables" and "Generics", based principally in the Middle East and North Africa ("MENA"), where it is a market leader, the United States and Europe.  In 2013, Hikma achieved revenues of $1,365 million and profit attributable to shareholders of $212 million. 

 

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