Pharmagen Announces Food and Drug Administration Registration
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 a multi-solution approach, Pharmagen is helping to meet the demand of the health provider market through independent wholesale, compounding, and IT solutions. Nationally focused, Pharmagen is a distributor of specialty drugs, compounding and admix pharmacy and producer of over-the-counter ("OTC") branded multivitamins. Pharmagen currently functions as a just-in-time source of supply for hospitals for those products that are hard-to-find due to drug manufacturers' production shortages.
Kymanox is a premier technical products and project management services organization. They are experts in providing clientele in the Biotech, Pharma, Device, and Nano industries with engineering, scientific, regulatory, and process operations support.
Safe Harbor Statement
Information in this document constitute forward-looking statements or statements which may be deemed or construed to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words "forecast", "anticipate", "estimate", "project", "intend", "expect", "should", "believe", and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve, and are subject to known and unknown risks, uncertainties and other factors which could cause Pharmagen actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. The risks, uncertainties and other factors are more fully discussed in Pharmagen's filings with the U.S. Securities and Exchange Commission. All forward-looking statements attributable to Pharmagen herein are expressly qualified in their entirety by the above-mentioned cautionary statement. Pharmagen disclaims any obligation to update forward-looking statements contained in this estimate, except as may be required by law.
SOURCE Pharmagen, Inc.