Navigation Links
Pharmagen Announces Food and Drug Administration Registration
Date:11/6/2013

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.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Pharmagen Announces Shift In Growth Strategy
2. CoMentis and Anvyl Announce Formation of Alpharmagen, a Joint Venture to explore Nicotinic Modulators
3. Pharmagen Announces First Quarter 2013 Results
4. Pharmagen to Present Strategic Vision for Solving Nations Parenteral Drug Shortage Crisis at 2013 BIO International Convention
5. Pharmagen Laboratories Remains Industry Leader on Patient Safety
6. Pharmagen Presents to North Carolina General Assembly at N.C. Bios Legislative Breakfast
7. Pharmagen Announces Year-End Financial Results
8. Auxilium Pharmaceuticals, Inc. Announces Third Quarter 2013 Financial Results
9. NxStage Announces Fourth Quarter 2013 Investor Conference Schedule
10. Genomic Health Announces Third Quarter 2013 Financial Results and Business Progress
11. GSI Group Announces Financial Results for the Third Quarter 2013
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... , May 24, 2016 Celsion ... drug development company, today provided an update on ... escalating clinical trial combining GEN-1, the Company,s DNA-based ... treatment of newly-diagnosed patients with advanced ovarian cancer ... debulking surgery.  GEN-1 is an IL-12 DNA plasmid ...
(Date:5/24/2016)... , May 24, 2016 ... ™ , la première endoprothèse à ... destinés à l,intervention portant sur les membres ... OrbusNeich, entreprise mondiale spécialisée dans ... changer la vie, a élargi son portefeuille ...
(Date:5/23/2016)... 2016 According to a ... by Product (Wheelchair, Scooters, Medical Beds, Bathroom Safety, ... Care, Wound), Accessories (Lifting, Transfer) & by End ... by MarketsandMarkets, the patient handling equipment market is ... at a CAGR of 10.5% during the forecast ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... May 26, 2016 , ... The Woodlands at ... offering a new model of care for living and healing, celebrated its grand opening, ... Life in a Real Home provided by Empowered Staff. , “This is an incredibly ...
(Date:5/26/2016)... Warner, New Hampshire (PRWEB) , ... May 26, 2016 , ... ... of which are designed, engineered, and manufactured in Warner, New Hampshire at the MadgeTech ... known to provide reliable monitoring solutions trusted by government agencies, including NASA. , ...
(Date:5/26/2016)... SURPRISE, ARIZ. (PRWEB) , ... May 26, 2016 , ... ... worry of American families. , The 550 employees of Sun Health Senior Living ... plan through Aetna that reduces their doctor and prescription copays for the year, while ...
(Date:5/26/2016)... ... May 26, 2016 , ... Leadership of Life Science Logistics ... organization has earned its ISO 13485 certification, indicating the company’s quality control system ... and policies associated with ISO quality standard 13485. , BSI Group America, ...
(Date:5/26/2016)... ... May 26, 2016 , ... North Cypress Medical Center hosted ... Club in Cypress. With the help of community partners, the event organizers raised $45,000 ... hope for wounded service members and their families through health, wellness, and therapeutic support. ...
Breaking Medicine News(10 mins):