APP Pharmaceuticals Receives Manufacturing Approval for Three Product Codes of Heparin at Puerto Rico Facility
18 August 2008 - 10:59PM
Business Wire
APP Pharmaceuticals, Inc. (Nasdaq: APPX), a leading provider of
hospital-based injectable pharmaceutical products, today said that
the U.S Food and Drug Administration (FDA) has approved APP�s
manufacturing facility in Barceloneta, Puerto Rico for the
manufacture of three product codes of Heparin Sodium Injection,
USP. �Bringing this third manufacturing site on-line is an
important part of our commitment to ensuring that an uninterrupted
and safe supply of heparin of the highest quality is available for
U.S. patients,� said Tom Silberg, chief executive officer of APP
Pharmaceuticals. �At the same time, we are now able to redeploy
some of our manufacturing capacity at our two other facilities
toward the production of other products to fulfill outstanding
orders. I commend the team for working diligently to bring our
Puerto Rico facility on-line quickly.� Silberg noted that, as a
result of recent events in the heparin market, APP is currently the
sole supplier of therapeutic heparin vials in the United States.
APP has nine products manufactured at its Puerto Rico facility,
including doxycycline, azithromycin and diphenhydramine. The
company anticipates manufacturing more than 19 million units in
Puerto Rico during 2008. Additionally, APP is conducting technical
transfers and stability production in an effort to transfer over 25
additional product codes to this facility, which should translate
to approximately 50 million units annually. About APP
Pharmaceuticals, Inc. APP is a fully-integrated pharmaceutical
company that develops, manufactures and markets injectable
pharmaceutical products with a primary focus on the oncology,
anti-infective, anesthetic/analgesic and critical care markets. The
Company offers one of the most comprehensive product portfolios
used in hospitals, long-term care facilities, alternate care sites
and clinics within North America and manufactures a comprehensive
range of dosage formulations. Forward-Looking Statement The
statements contained in this news release that are not purely
historical are forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements in this news release include statements
regarding our expectations, beliefs, hopes, goals, intentions,
initiatives or strategies, including statements regarding the
demand, supply and distribution of heparin. Because these
forward-looking statements involve risks and uncertainties, there
are important factors that could cause actual results to differ
materially from those in the forward-looking statements. These
factors include, but are not limited to, the availability and
pricing of ingredients used in the manufacture of pharmaceutical
products and the ability to successfully manufacture products in a
time-sensitive and cost effective manner. Additional relevant
information concerning risks can be found in APP Pharmaceuticals,
Inc. Form 10-K for the year ended December 31, 2007 and other
documents it has filed with the Securities and Exchange Commission.
The information contained in this news release is as of the date of
this release. APP assumes no obligations to update any
forward-looking statements contained in this press release as the
result of new information or future events or developments.
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