Hikma Pharmaceuticals Plc Successful resolution to US FDA warning letter (8029D)
April 02 2014 - 2:00AM
UK Regulatory
TIDMHIK
RNS Number : 8029D
Hikma Pharmaceuticals Plc
02 April 2014
Hikma announces successful resolution to US FDA warning letter
at Eatontown facility
London, 2 April 2014 - Hikma Pharmaceuticals PLC ("Hikma") (LSE:
HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), the fast growing
multinational pharmaceutical group, today announces that we have
received a close-out letter from the US Food and Drug
Administration ("US FDA") that lifts the warning letter received in
February 2012 in respect of its Eatontown facility in New Jersey,
which provides oral products for the US market. This communication
follows the US FDA's re-inspection of the facility in February 2014
to complete its evaluation of the corrective actions we have taken
in response to the warning letter. This successfully resolves all
issues raised by the US FDA in February 2012 and all subsequent
communications.
Said Darwazah, Chief Executive Officer of Hikma commented:
"I am pleased to report that we have brought the Eatontown
facility back into compliance with the US FDA. The investment we
have made to complete the remediation work, upgrade our
manufacturing processes and strengthen our operations, provides
greater quality and support for our customers and we are committed
to continuing to invest in the highest quality standards. We are
gradually re-introducing products to the US market from the
Eatontown facility, adding to the products we supply from our US
FDA approved facilities in Jordan and Saudi Arabia. We believe
there are an increasing number of attractive market opportunities
for our Generics business and we are investing in our pipeline of
oral and other non-injectable product forms, whilst continuing to
look for further product acquisition opportunities."
We expect the Generics business to deliver revenue of around
$170 million in 2014, with an adjusted operating margin of above
25%.
-- ENDS --
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal, VP Corporate Strategy and Investor Relations +44
(0)20 7399 2760/ +44 7776 477050
Lucinda Henderson, Deputy Head of Investor Relations +44 (0)20
7399 2765/ +44 7818 060211
FTI Consulting
Ben Atwell/ Matthew Cole/ Julia Phillips +44 (0)20 7831 3113
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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