PURE Bioscience Announces cGMP Certification of Manufacturing Facility and Process and FDA Registration of Drug Establishment
cGMP Certification and FDA Registration Prepare PURE for Production of SDC as an Active Pharmaceutical Ingredient
SAN DIEGO, Calif. September 5, 2007— PURE Bioscience (OTCBB: PURE) today announced the Current Good Manufacturing Practice (cGMP) certification by Peiser & Associates, Inc. of PURE’s manufacturing facility and process for the production of its pharmaceutical-grade silver dihydrogen citrate (SDC) concentrate as an Active Pharmaceutical Ingredient (API). In addition, PURE has completed the Registration of Drug Establishment with the US Food and Drug Administration (FDA).
“This is a necessary step for PURE to be able to fulfill our requirement to provide SDC as an Active Pharmaceutical Ingredient to our current and prospective pharmaceutical development partners. Establishing the cGMP facility and production processes ensures that we meet the highest industry guidelines for the safety and quality of our API product,” stated
Eugene S. Peiser, Doctor of Pharmacy and President of Peiser & Associates, Inc., commented, “Peiser & Associates, Inc. has inspected and Certified many Pharmaceutical manufacturers and distributors during our many years of operation (we established the firm in 1974) and in our opinion, PURE Bioscience can be considered one of the top producers of Active Pharmaceutical Ingredients (API), and we are proud to present the firm with our "CERTIFICATE OF CGMP COMPLIANCE” for the manufacture of SDC concentrate.”
About Peiser & Associates, Inc.
Peiser & Associates, Inc. is one of the oldest and most respected FDA Compliance Consulting firms in the
About PURE Bioscience
PURE Bioscience (PURE) develops and markets technology-based bioscience products that provide solutions to numerous global health challenges. PURE's proprietary high efficacy/low toxicity bioscience technologies, including its silver dihydrogen citrate-based antimicrobials, represent innovative advances in diverse markets and lead today's global trend toward industry and consumer use of "green" products while providing competitive advantages in efficacy and safety. Patented silver dihydrogen citrate (SDC) is an electrolytically generated source of stabilized ionic silver. SDC is colorless, odorless, tasteless, non-toxic, non-caustic and formulates well with other compounds. As a platform technology, SDC is distinguished from competitors in the marketplace because of its superior efficacy, reduced toxicity and the inability of bacteria to form a resistance to it. SDC also offers 24-hour residual protection against standard indicator bacteria. PURE Bioscience, headquartered inEl Cajon,
This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe", "estimate", "project", "expect" or similar expressions. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, acceptance of the Company's current and future products and services in the marketplace, the ability of the Company to develop effective new products and receive regulatory approvals of such products, competitive factors, dependence upon third-party vendors, and other risks detailed in the Company's periodic report filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release.
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