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Active pharmaceutical ingredient: a substance intended to be incorporated into a FINISHED MEDICINAL PRODUCT intended to obtain pharmacological activity or any other direct effect in the diagnosis or monitoring of a disease or manifestation of a disease in humans, but not the intermediates used in the synthesis of such a substance. Proposed rule. For example, compounds in one final product can be converted into other compounds by chemical reactions in the body before they reach the site of therapeutic action, and related but different drug molecules may be clinically indistinguishable or transform into the same pharmacologically or physiologically active component in the body.7 This phenomenon raises the question of which molecule – the one present before or after ingestion – the molecules relevant for the determination of drugs.8 The comparison of active substances can be technically quite complicated. For example, compounds in one final product can be converted into other compounds by chemical reactions in the body before arriving at the site of therapeutic action. In addition, related but different drug molecules can be clinically indistinguishable or transform into the same pharmacologically or physiologically active component in the body. Alternatively, two drug molecules with the same nuclear compound may have different compounds attached to them by covalent or non-covalent bonds. For example, replacing a hydrogen atom in an acid molecule with “a metal or its equivalent” forms a salt, while replacing the hydrogen atom with “an organic radical” forms an ester. These derivatives may or may not differ from each other in a clinically significant way. This raises the question of which derivative(s), if any, should be considered as the same active substance as the nuclear or basic molecule. In general, a broader interpretation of the term “active ingredient”,i.e., one that considers several types of derivatives to be the same active ingredient, reduces the number of drugs eligible for regulatory exclusivity in ECNs by expanding the pharmaceutical ingredients previously considered approved, allowing for the earlier introduction of generic versions of these drugs. WHO Good Distribution Practices for Pharmaceuticals EU Basic GMP Requirements for Active Substances Used as Raw Materials – The EU GMP for APIs containS GMP guidelines for the manufacture of active substances under an appropriate quality management system. Related to this question is whether the term active unit should include other covalent derivatives that are converted into the same compound in order to achieve the therapeutic effect.

APIC – Manufacture of Sterile Active Pharmaceutical Ingredients – Guide 1999 Model for the “Written Confirmation” of Active Substances Exported to the European Union for Medicinal Products for Human Use Actavis, a generic manufacturer seeking to market a generic version of Vyvanse, claimed that dextroamphetamine was responsible for the therapeutic effect in the body and that the FDA had previously approved drugs containing dextroamphetamine. Vyvanse was not entitled to the exclusivity of the ECR.72 Actavis focused on the term “active,” stating that “active ingredient” must necessarily refer to “the drug molecule that reaches the `place` of action of the drug” because that is the part of the drug responsible for its “activity,” which Activis says means therapeutic effect.73 The U.S. FDA has no formal regulatory definition of the term “excipient.” submissive.. .