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Wojciech Danysz1

  • 1Merz Pharmaceuticals GmbH, Department of Behavioural Pharmacology, Eckenheimer Landstrasse 100, Frankfurt am Main, D-30618, Germany. Wojciech.Danysz@merz.de

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Pharmaceutical Equivalents

As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.