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FDA Hits Alembic Pharmaceuticals With Warning Letter Over Informed Consent Failures At Indian Bioequivalence Site

Alembic Pharmaceuticals has received a formal warning letter from the U.S. Food and Drug Administration targeting its bioequivalence research facility in Vadodara, India. The warning letter, dated July 10, 2026, follows an FDA inspection of the Alembic Research Centre Bioequivalence facility conducted between March