Approvals Significantly Expand Manufacturing Capacity for Heparin
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.
APP Pharmaceuticals, Inc.
Maili Bergman
Director,
Investor Relations
310-405-7522
or
PondelWilkinson Inc.
Robert
Jaffe, 310-279-5969
