Achieving ISO class 5 certification allows ReceptoPharm to become one of the few select cleanrooms in the United States certified to complete Phase I and II sterile drug fills for United States and European clinical trials
Nutra Pharma Corp., a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that its wholly-owned drug discovery subsidiary, ReceptoPharm, has achieved ISO class 5 certification for its cleanroom manufacturing and laboratory facility.
“Achieving ISO class 5 certification is an important milestone for our clinical development program,” commented Dr. Paul Reid, CEO of ReceptoPharm. “It not only shows our long-term commitment to adopting the highest quality standard for our operations, but it also provides us with greater control over our drug production capabilities,” he added.
The upgraded ReceptoPharm facility is used primarily for the development and production of RPI-78, RPI-78M and RPI-MN, ReceptoPharm’s leading drug candidates being studied for the treatment of Multiple Sclerosis (MS), Adrenomyeloneuropathy (AMN), HIV, pain, and Rheumatoid Arthritis.
“In addition to maintaining higher quality standards, completing the ISO 5 certification process provides ReceptoPharm with significant cost savings for an operation that was previously contracted out to third-party firms,” explained Rik J Deitsch, Chairman and CEO of Nutra Pharma. “More specifically, ReceptoPharm is now approved to complete its own sterile drug fills for our upcoming trials in the United States and in Europe,” he concluded.
The successful ISO certification audit was conducted in February 2009 by Biotec. Biotec is a UK-based firm specializing in European clinical drug import and distribution.
This press release contains forward-looking statements. The words or phrases "would be," "will allow," "intends to," "will likely result," "are expected to," "will continue," "is anticipated," "estimate," "project," or similar expressions are intended to identify "forward-looking statements." Actual results could differ materially from those projected in Nutra Pharma's ("the Company") business plan. The Company's business is subject to various risks, which are discussed in the Company's filings with the Securities and Exchange Commission ("SEC"). ReceptoPharm’s achievement of ISO class 5 certification should not be construed as an indication in any way whatsoever of the value of the Company or its common stock. The Company's filings may be accessed at the SEC's Edgar system at www.sec.gov. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. The Company cautions readers not to place reliance on such statements. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim any obligation, to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.