Active Ingredient definition

Active Ingredient means the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

Active Ingredient means any com- ponent that is intended to furnish pharmacological activity or other di- rect effect in the diagnosis, cure, miti- gation, treatment, or prevention of dis- ease, or to affect the structure or any function of the body of humans. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.

Active Ingredient means any ingredient which will:

Examples of Active Ingredient in a sentence

• QA, TFI and LI denote the Quantity of Active Ingredient, Treatment Frequency Index and Load Index Indicators, respectively.

• Active Ingredient – any substance (or group of structurally similar substances if specified by the Agency) that will prevent, destroy, repel or mitigate any pest, or that functions as a plant regulator, desiccant, or defoliant within the meaning of FIFRA sec.

• The parties agree to establish an annual business review process pursuant to which the parties will review (either in person, by telephone, videoconference or other mutually agreeable means) Active Ingredient quality, cycle time, manufacturing capacity, projected market needs, and delivery.

• Notwithstanding the foregoing, in the event that Reliant requests a change to the Specifications, ASL shall notify Reliant within 30 days of ASL’s receipt of such request whether the requested change will result in a material increase or decrease in the direct cost of manufacture of the Active Ingredient and ASL’s estimate of the cost of implementing the change.

• ASL shall provide Reliant with immediate notification of its receipt of any of the following related to the manufacture, production or testing storage of the Active Ingredient; a copy of any list of observations (Form FD483), Warning Letters, Information Letters, Regulatory Letters or the like issued by the FDA as well as provide Reliant an opportunity to review any written response prior to submission to the FDA.

More Definitions of Active Ingredient

Active Ingredient means any component that furnishes pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or that affects the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug, that are present in the finished drug product in a modified form, and that furnish the specified activity or effect.

Active Ingredient means any substance (or group of structurally similar substances if specified by the United States Environmental Protection Agency) that will prevent, destroy, repel or mitigate any pest, or that functions as a plant regulator, desiccant, or defoliant within the meaning of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 2(a). (See 40 CFR 152.3). Active ingredient also means a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for the production of such a pesticidal substance. (See 40 CFR 174.3).

Active Ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagno- sis, cure, mitigation, treatment, or prevention of disease, or to af- fect the structure or any function of the body of humans or other ani- mals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in that drug product in a modified form intended to furnish the specified ac- tivity or effect.

Active Ingredient means a component of a soil or plant additive from which the soil or plant additive derives all or part of its value or effectiveness and which is:

Active Ingredient means any ingredient which will prevent, destroy, repel, control, or mitigate pests, or which will act as a plant regulator, defoliant, desiccant, or spray adjuvant.

Active Ingredient means an ingredient, which defoliates

Active Ingredient means the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding, for the avoidance of doubt, formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).