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.
About 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.
Contact: 888-264-4597 or
info@pharmagenrx.com
Follow Us on Twitter: @pharmagenrx or
The Drug Shortage
Report http://drugshortagereport.blogspot.com/
About Kymanox
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.