Pharmagen Laboratories Remains Industry Leader on Patient Safety
Published: Apr 11, 2013
SILVER SPRING, Md., April 10, 2013 /PRNewswire/ -- Pharmagen, Inc. (OTCBB: PHRX) (the "Company" or "Pharmagen") is excited to announce that it has entered into an agreement to use proprietary ScanRDI technology from BioMerieux. Pharmagen Laboratories is only one of five sterile compounding companies in the United States to use ScanRDI, a cutting edge technology that reduces the method time for product sterility testing from 14 days to less than 3 hours. Utilizing solid phase cytometry in conjunction with fluorescent viability staining, ScanRDI allows for product sterility results in a matter of minutes. This is the only technology in the world that can detect contamination down to one viable microorganism without the need for growth or enrichment. While most compounding companies randomly skip-lot test, Pharmagen Laboratories tests every lot, every time. With this new, unparalleled turnaround time, Pharmagen can now produce new compounds in a matter of hours giving the company an enormous competitive advantage in responding to an ever-changing market place.
"Patient safety in compounding has become a hot topic after New England Compounding Center's meningitis outbreak and there isn't another company out there that takes it as seriously as we do. Pharmagen has passed recent FDA and State Board of Pharmacy inspections, in addition to hiring an industry leading consulting firm, Kymanox, for an independent review. Taking lessons from the pharmaceutical manufacturing space, we're instituting cutting edge Standard Operating Procedures, and as many USP and cGMP guidelines as we can in a compounding environment. We see competitors testing a small percentage of what leaves their facilities. Products from typical compounding facilities are shipped prior to having test results in hand, resulting in recalls on an almost daily basis. Pharmagen tests absolutely everything we produce and nothing leaves our facility until we know it's safe," said Mackie A. Barch, CEO of Pharmagen.
"Additionally, the demands of the health provider market are extremely dynamic. Being able to save two weeks give us a real advantage because two weeks is a lifetime in this business both for us and the patients we ultimately serve," continued Barch.
Pharmagen, Inc. ("Pharmagen"), and wholly owned subsidiaries and operating divisions Pharmagen Laboratories, Inc., Pharmagen Distribution, LLC and Pharmagen Nutraceuticals, Inc. is the leader in innovative solutions to the nations sterile pharmaceutical crisis. With a multifaceted approach, Pharmagen is meeting the demand of health provider market through dynamic, independent wholesale, compounding, and innovative IT solutions. Nationally focused, Pharmagen is a dynamic distributor of specialty drugs, compounding and admix pharmacy and producer of over-the-counter ("OTC") branded multivitamins to the healthcare provider market. 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, with headquarters now in RTP, NC, is a premier technical products and technical project management company. We have expertise in providing engineering, scientific, regulatory, and process development support to companies involved in Biopharmaceutical, Medical Device, and Nanotechnology development. Kymanox has a proven track record in solving complex scale-up, technology transfer, and manufacturing problems as well as receiving positive feedback from the FDA on executing complex approval pathways for next generation drugs. With our focus on commercialization, Kymanox helps bring new products to patients in need.
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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' 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.