Drug Substances definition

Drug Substances means the active ingredient(s) in the respective Products, listed in Annex 3 attached hereto.
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Drug Substances has the meaning set forth in the Asset Purchase Agreement.
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Drug Substances or “BDS” means *** .
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Examples of Drug Substances in a sentence

  • Schedule 8 — Controlled Drug Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence.

  • USP also notes that it plays no role in enforcement and that regulators continue to have the authority to make their own determinations regarding enforceability of Chapter <800>.FDA Issues Statement on Compounded Bulk Drug Substances RulingA US district court judge in Washington, DC, recently upheld Food and Drug Administration’s (FDA’s) interpre- tation of clinical need regarding bulk substances that may be used by outsourcing facilities in drug compounding.

  • Guidance for Industry: Q3A Impurities in New Drug Substances, February 2003, http://www.fda.gov/cber/gdlns/ichq3a.pdf.

  • The conditions meet the requirements of the International Conference for Harmonization, as described in Q1A(R2) “Stability Testing of New Drug Substances and Products”.

  • Gather committee Participants and Attendees to ask targeted questions for situational awareness related to the active Plans of Action (PPE, Drug Products and Drug Substances, Diagnostic Test Kits, Medical Devices, and Medical Gases).2.

  • II.2 Drug Substances CarvedilolThe active substance is carvedilol, an established active substance described in the European Pharmacopoeia (Ph.Eur.).

  • Guidance for Industry: Q11 Development and Manufacture of Drug Substances, November 2012.

  • This work addresses the challenge of using what Tang and colleagues (2005) call pseudo-ancestors.

  • Q1A(R2) Stability Testing of New Drug Substances and Products, Guidance for Industry (Nov.

  • Furthermore, Novartis is not responsible for conducting any studies, including clinical and stability studies, concerning the Drug Substances and/or the Products, which may be requested by the Regulatory Authority or any Governmental Authority after the Closing Date, regardless of whether the MA Transfer Date has occurred or not.

Related to Drug Substances

  • 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.

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

  • Finished Products means the fully assembled and shrink-wrapped Licensed Products, each including a Game Cartridge, Game Cartridge label and Printed Materials.

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

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

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

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

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

  • API means the American Petroleum Institute.

  • processed products means goods placed under a processing procedure which have undergone processing operations;

  • Products means information resources technologies that are, or are related to, EIR.

  • Manufacturing Process means any process for—

  • Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities.

  • Raw Materials means all raw materials, supplies, components and packaging necessary to manufacture and ship the Product in accordance with the Specifications, as provided in Exhibit A, but not including the API.

  • Product Specifications means those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

  • 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.

  • 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).

  • 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.

  • Samples mean representative physical examples of materials, equipment or workmanship, used to confirm compliance with requirements and/or to establish standards for use in execution of the Work.

  • 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;

  • cGMPs means current good manufacturing practices as described in Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations together with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;

  • Inert ingredient means an ingredient which is not an active ingredient.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • Biological Materials means certain tangible biological materials that are necessary for the effective exercise of the Patent Rights, which materials are described on Exhibit A, as well as tangible materials that are routinely produced through use of the original materials, including, for example, any progeny derived from a cell line, monoclonal antibodies produced by hybridoma cells, DNA or RNA replicated from isolated DNA or RNA, recombinant proteins produced through use of isolated DNA or RNA, and substances routinely purified from a source material included in the original materials (such as recombinant proteins isolated from a cell extract or supernatant by non-proprietary affinity purification methods). These Biological Materials shall be listed on Exhibit A, which will be periodically amended to include any additional Biological Materials that Medical School may furnish to Company.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • 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.”