cGMP certification and FDA registration prepare PURE for production of SDC as an active pharmaceutical ingredient
September 5, 2007 — SAN DIEGO, CA — PURE Bioscience 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 U.S. 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,” states Michael L. Krall, president and CEO of PURE Bioscience. A facility with cGMP production certification is recognized as having the proper equipment, technical expertise, controls, and procedures to produce API for human applications.
Eugene S. Peiser, Doctor of Pharmacy and president of Peiser & Associates, Inc., comments, “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 United States. Established in 1974 at the request of FDA to assist in providing expert advice to firms regulated under state and federal good manufacturing practice regulations (CGMP), Peiser & Associates, Inc. has provided assistance to firms operating in the U.S., Puerto Rico, England, and Israel. To receive a Certificate of cGMP Compliance, a firm must be in substantial compliance with all FDA rules and regulations.
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 in El Cajon, CA (San Diego metropolitan area), was incorporated in 1992. Additional information about PURE Bioscience is available at www.purebio.com.