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news.APP Pharmaceuticals has announced that the FDA has approved the company's manufacturing facility in Barceloneta, Puerto Rico for the manufacture of three product codes of Heparin sodium injection, USP.
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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.
Tom Silberg, CEO of APP Pharmaceuticals, said: “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 US patients.”