Hikma Pharmaceuticals Plc Hikma announces receipt of Warning Letter from FDA (1798V)
October 24 2014 - 2:00AM
UK Regulatory
TIDMHIK
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.
-- ENDS --
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal, VP Corporate Strategy and Investor Relations +44
(0)20 7399 2760/ +44 7776 477050
Lucinda Baker, Deputy Head of Investor Relations +44 (0)20 7399
2765/ +44 7818 060211
FTI Consulting
Ben Atwell/ Matthew Cole/ Julia Phillips +44 (0)20 3727 1000
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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