APP Pharmaceutical Endorses New USP Standards for Unfractionated Heparin

APP Pharmaceuticals, Inc., a subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., and a supplier of heparin sodium to the U.S. market, announced its continued support of the US Food & Drug Administration (FDA) and medical community for the October 1, implementation of the new United States Pharmacopeia (USP) monograph change for unfractionated heparin.

In a release, the Company noted that the purpose of the USP monograph changes are to further assure the purity of the Active Pharmaceutical Ingredient (API) through specific assay tests and calibrate activity to align with the International Standard (IS) issued by the World Health Organization (WHO).

"As a proven leader in providing safe, efficacious and rigorously tested heparin products to the U.S. market, APP has always met or exceeded USP standards. From safety and quality measures in the manufacturing process, to helping prevent medical errors with cap, label and bar code enhancements, we remain committed to our promise of consistent supply and unparalleled quality," said Thomas H. Silberg, President and Chief Executive Officer of APP Pharmaceuticals.

In order for customers to clearly differentiate product tested using the new USP standards, APP will be incorporating an "N" (for "new") after the expiration date on every vial. An example of the vial label designation can be seen at APPpharma.com.

To support the medical community's understanding and readiness for the new USP monograph change for unfractionated heparin and the introduction of new USP Reference Standards (RS), APP launched an educational webinar series with industry experts as part of its ongoing safety initiative, "Working Together for Patient Safety."

"We will continue our collaborative work with the FDA to develop the best industry solutions for implementing and meeting these new USP standards and provide customers with greater confidence in the purity of their Heparin product," said Christopher Bryant, PhD, Chief Scientific Officer of APP Pharmaceuticals. "The educational webinar series we launched in September of this year is just part of APP's extensive efforts to bring these best practice solutions to our customers and ensure a safe supply of heparin for thousands of patients."

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