Ad-hoc | 24 February 2012 13:00
Fresenius SE & Co. KGaA / Key word(s): Miscellaneous
24.02.2012 13:00
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APP Pharmaceuticals receives FDA warning letter regarding Grand Island
plant - no material financial impact expected
APP Pharmaceuticals ('APP'), a subsidiary of Fresenius Kabi, has received a
warning letter dated 22 February 2012 from the New York District FDA office
regarding the Company's Grand Island plant. The warning letter follows an
inspection at the facility which concluded in July 2011. The Company
responded on 27 July 2011 detailing the corrective and preventative actions
planned to address the Agency's concerns, and since then has made
significant progress in collaboration with the FDA in remedying these
issues. In addition, the warning letter refers to the marketing status of
five 'grandfathered' generic products with a total annual sales volume of
approx. EUR15 million.
The Company has full confidence in the quality of the products it has
distributed from the Grand Island facility and expects to continue
production at the plant. We believe that the ongoing enhancement efforts
can be successfully completed without disrupting output.
Both APP and Fresenius Kabi are committed to the highest standards of
quality and compliance in manufacturing across its global operations. We
regard our relationship with the FDA as critical to both our past and
future success, and we will continue to work constructively and
expeditiously with the Agency to resolve all the issues addressed in the
warning letter.
APP will respond to the FDA within the required 15 working day time frame.
No material sales and earnings impact on Fresenius Kabi's U.S. business is
expected, and Fresenius Kabi fully confirms its 2012 guidance.
Fresenius SE & Co. KGaA,
represented by Fresenius Management SE,
Board of Management
Bad Homburg v.d.H., February 24, 2012
End of note
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Language: English
Company: Fresenius SE & Co. KGaA
Else-Kröner-Straße 1
61352 Bad Homburg v.d.H.
Germany
Phone: +49 (0)6172 608-2485
Fax: +49 (0)6172 608-2488
E-mail: ir-fre@fresenius.com
Internet: www.fresenius.com
ISIN: DE0005785604
WKN: 578560
Indices: DAX
Listed: Regulierter Markt in Düsseldorf, Frankfurt (Prime Standard),
München; Freiverkehr in Berlin, Hamburg, Hannover, Stuttgart;
Terminbörse EUREX
End of Announcement DGAP News-Service
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