PURE another new hod tuna, more big FDA news:
PURE Bioscience Announces cGMP Certification of Manufacturing Facility and Process and FDA Registration of Drug Establishment
Wednesday September 5, 8:14 am ET
cGMP Certification and FDA Registration Prepare PURE for Production of SDC as an Active Pharmaceutical Ingredient
SAN DIEGO--(BUSINESS WIRE)--PURE Bioscience (OTCBB:PURE - News) 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 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., 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."
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