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FDA Issues Warning Letter to Apotex
November 05, 2025
WASHINGTON, Nov. 5 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Apotex Inc. from the Center for Drug Evaluation and Research:

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Recipient: Mr. Allan Oberman, President & Chief Executive Officer, Apotex Inc., 150 Signet Drive, Toronto ON M9L 1T9, Canada

Issuing Office: Center for Drug Evaluation and Research (CDER), United States

Warning Letter 320-26-12

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