SILVER SPRING, Md., Nov. 6, 2013 /PRNewswire/ -- Pharmagen, Inc. (OTCQB: PHRX) (the "Company" or "Pharmagen") announces that it has completed the registration of Pharmagen Laboratories with the Food and Drug Administration ("FDA"). Since the tragic fungal meningitis outbreak associated with New England Compounding Center (NECC) in late 2012, Pharmagen recognizes the need for FDA's oversight of the sterile compounding industry. In an effort to embrace the pending changes in compounding pharmacy regulation, Pharmagen's registration with the FDA moves the Company closer to full cGMP compliance – including adherence to Federal Statutes 21 CFR Parts 11, 210, and 211.
Since September, Pharmagen has brought in cGMP compliance expert Kymanox to review the Company's laboratory operations. Pharmagen has also hired a full-time cGMP, Director of Compliance, that served a similar role at Teva Pharmaceuticals. The Company anticipates hiring a second, full-time, cGMP compliance professional before the end of the year. Pharmagen, in conjunction with Kymanox and other outside advisors, has formulated a strategic plan designed to keep the Company on a path to becoming a leader in compounding cGMP compliance.
"The meningitis outbreak changed the industry and we welcome the FDA's oversight of sterile compounding. The FDA sets the world standard for quality; we are embracing cGMP and are ready to augment our current USP standards. Pharmagen has always wanted to set the standard for quality and cGMP sets the bar high. It's a great thing for our patients and shareholders," said Mackie A. Barch, CEO of Pharmagen.
Pharmagen, Inc. ("Pharmagen"), and wholly owned subsidiaries and operating divisions Pharmagen Laboratories, Inc., Pharmagen Distribution, LLC and Pharmagen Nutraceuticals, Inc. offers innovative solutions to the nations sterile pharmaceutical crisis. With
|SOURCE Pharmagen, Inc.|
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