Active Drug Substance definition

Active Drug Substance means the compound modafinil having those specifications as set forth on Schedule A hereto.
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Active Drug Substance means [CHEMICAL NAME] having those specifications as set forth on Schedule A hereto.
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Active Drug Substance means (a) [***](known as fasudil), and (b) any of its [***] (c) compounds that are [***] (or as does any other form of it referred to in the foregoing clause (b)), and (d) [***].
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Examples of Active Drug Substance in a sentence

  • CEPHALON shall deliver all Active Drug Substance and Compressil necessary to formulate Product for any given shipment to CATALYTICA not less than sixty (60) days in advance of said delivery date.

  • Following such delivery, CIRCA shall assume full responsibility for the safekeeping and safe handling, and shall bear all risk of loss, of all such Active Drug Substance that is in its possession.

  • Xxxxxxxx ------------------------------------ -18- SCHEDULE A ---------- ACTIVE DRUG SUBSTANCE AND STARTING MATERIAL SPECIFICATIONS; TRADEMARKS ---------------------------------------------------------------------- The parties have agreed upon all those applicable specifications for the Active Drug Substance and Starting Materials as set forth in the following documents.

  • In addition, CATALYTICA will maintain at all times sufficient property casualty insurance to cover the total quantity of Active Drug Substance and Product on hand at its full cost of replacement.

  • CIRCA will use its best efforts to obtain maximum yield of Product from the Active Drug Substance provided by CEPHALON in connection with the formulation and packaging services provided hereunder.

  • CEPHALON must deliver all Active Drug Substance necessary to formulate Product for any given shipment to CIRCA not less than ninety (90) days in advance of said date of shipment.

  • CEPHALON will provide free of charge, and --------------------- deliver to CIRCA at its designated production facility not less than thirty (30) days in advance of the date of production of Product, appropriate quantities of Active Drug Substance which meets the specifications established in Schedule A.

  • Upon termination under this Article, CATALYTICA shall, at CEPHALON's expense, return promptly to CEPHALON all Product, Active Drug Substance, in process materials and packaging components in its possession on the effective date of termination.

  • Legal title to all Active Drug Substance will remain with CEPHALON, provided however, that CIRCA shall reimburse CEPHALON for the replacement cost of any Active Drug Substance that is lost, contaminated, or destroyed while in the possession of CIRCA.

  • Their stories need to be listened to and described in such a way that they not only agree with the factual correctness of their experiences, but also agree with the spiritual and emotional contexts of their experiences and how these are described in the research.


More Definitions of Active Drug Substance

Active Drug Substance means the compound N-(4, 4-di (3-methyl-2-thienyl) but-3-en-1-yl) nipecotic acid, which is more commonly known as tiagabine having those specifications as set forth on Schedule A hereto.
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Active Drug Substance means either the Exendin-4 Compound (currently marketed by Amylin as Byetta(R)) or, if the parties agree to a Substitute Compound as provided in Section 3.1(c), the Substitute Compound then being developed, in each case prior to its combination with any other excipient or molecule (whether such molecule is therapeutically active or has no therapeutic activity) or any molecule used to enable permeation of a drug across membranes.
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Related to Active Drug Substance

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • 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).

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Manufacturing Process means any process for—

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • API means the American Petroleum Institute.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;