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FDA Approvals - PURE Bioscience Announces cGMP Certification of Manufacturing Facility and Process


PURE Bioscience Announces cGMP Certification of Manufacturing Facility and Process and FDA Registration of Drug ... (Business Wire via Yahoo! Finance)
SAN DIEGO----PURE Bioscience today announced the Current Good Manufacturing Practice certification by Peiser & Associates, Inc. of PURE's manufacturing facility and process for the production of its pharmaceutical-grade silver dihydrogen citrate concentrate as an Active Pharmaceutical Ingredient .

Teva Receives Favorable Court Decision Regarding Generic Famvir(R) Tablets; Novartis' Motion for Preliminary Injunction ... (FinanzNachrichten)
Teva's Abbreviated New Drug Application (ANDA) to market its Famciclovir Tablets, 125 mg, 250 mg and 500 mg has already been granted final approval by the U.S. Food and Drug Administration (FDA). The brand product had annual sales of approximately $200 million in the United States for the twelve months ended June 30, 2007, based on IMS sales data.

Access To High-Quality, Low-Cost Antiretrovirals In Developing Countries Major Challenge In Fight Against HIV/AIDS, ... (Medical News Today)
A "little-noticed milestone was reached in the fight to save lives from AIDS with high-quality antiretroviral treatment" last week when FDA "granted its 50th and 51st priority approvals for HIV/AIDS medications, making them eligible for purchase" by the President's Emergency Plan for AIDS Relief, Ambassador Mark Dybul, who serves as the U.S. [click link for full article]
 

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