Excipient definition

Excipient means [***].
Excipient means a substance intended to be used as is or in the manufacture of a medicinal product for a specific function, but does not exert pharmacological activity;
Excipient means a substance that is used as a diluent or vehicle for the Modified Protein and is part of the Bulk Product to formulate the Product, including, but not limited to albumin.

Examples of Excipient in a sentence

  • If Theravance or such independent expert determines that such shipment does not meet the API Specifications and/or Excipient Specifications, Theravance shall replace, at no cost to Hospira, the portion of the API and/or Excipient shipment which does not conform to the API Specifications and/or Excipient Specifications and bear all expenses of shipping and testing the shipment samples.

  • For greater clarity, Hospira’s liability under (iii), above, explicitly excludes loss of API during any and all aspects of compounding, filling and finishing the API, the Excipient and/or Product.

  • Notwithstanding the [***] terms of Section 5.4(a)(i), [***] to the API and Excipient while they are in the Facility.

  • In the event Hospira notifies Theravance that the API and/or Excipient shipment does not conform to the API Specifications and/or Excipient Specifications, Theravance shall have the right to confirm such findings at the Facility.

  • Hospira shall use the API and Excipient received from Theravance only for the technology transfer activities contemplated by this Agreement and the manufacture of Product for Theravance hereunder.


More Definitions of Excipient

Excipient means any substance other than the API used in formulating the Compounded Bulk.
Excipient means any substance, other than the API, used in formulating the Product.
Excipient means an inactive ingredient, as defined in Title 21 of the U.S. Code of Federal Regulations Part 201.
Excipient means ***, in all instances intended to meet the Specifications, manufactured in accord with cGMP and sold by SAFC to Company.
Excipient means any constituent of a medicinal product other than the active substance and the packaging material;”;
Excipient means any components other than APIs that are commonly used in a pharmaceutical product. These components may include vehicles and additives, such as dyes, flavors, binders, emollients, fillers, lubricants, and preservatives. "Firm" means any business within the customs territory of China or within the United States that is engaged in the manufacture (including processing) and distribution (including export) of Drugs, Excipients, and Medical Devices. "HHS/FDA Requirements" means any U.S. laws, regulations or other requirements, including any amendment adopted after the date of entry into force of this Agreement, concerning Drugs, Excipients, and Medical Devices that are administered or enforced by HHS/FDA. "SFDA Requirements" means any Chinese laws, regulations or other requirements, including any amendment adopted after the date of entry into force of this Agreement, concerning Drugs, Excipients, and Medical Devices that are administered or enforced by SFDA. "Medical Device" means any instrument, apparatus, machine, implant, in vitro reagent, or similar or related article, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in humans, or intended to affect the structure or any function of the human body, and which is not a drug. "SFDA-Registered Firm" means a Firm that SFDA has determined meets SFDA Requirements and that is registered with SFDA. "HHS/FDA Registered Firm" means a firm that complies with U.S. registration and listing requirements and that is registered with HHS/FDA. "Facility" means any Firm´s site within the customs territory of China or in the United States that is engaged in manufacturing, producing, processing, packing, testing, holding, transporting, distributing, or exporting Drugs, Excipients, and Medical Devices.
Excipient means an essentially inert substance used as a diluent or to give form or consistency to a formulation. "Effective" or "therapeutically effective" is meant to describe a compound or a composition of the present invention effective in antagonism of thrombin receptors and thus producing the desired therapeutic, ameliorative, inhibitory or preventative effect. "Effective amount" or "therapeutically effective amount" is meant to describe an amount of compound or a composition of the present invention effective in antagonism of thrombin receptors and thus producing