APP Pharmaceuticals, Inc., a leading provider of hospital-based injectable pharmaceutical products,  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.