Active Pharmaceutical Ingredient Specifications definition

Active Pharmaceutical Ingredient Specifications means the detailed description and parameters of the API set forth on Exhibit 1.3.
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Active Pharmaceutical Ingredient Specifications or “API Specifications” means the detailed description and parameters of the API set forth on Exhibit 1.3.
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Active Pharmaceutical Ingredient Specifications means the detailed description and parameters of the API set forth on Exhibit 1.2.
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Examples of Active Pharmaceutical Ingredient Specifications in a sentence

  • All shipments of Active Pharmaceutical Ingredient shall be accompanied by a certificate of analysis from the Active Pharmaceutical Ingredient manufacturer confirming the identity, purity and compliance with the Active Pharmaceutical Ingredient Specifications covering such Active Pharmaceutical Ingredient.

  • Serendex reserves the right to reject any Lot of Active Pharmaceutical Ingredient or subdivision thereof by reason of the failure of such Lot to meet any applicable specification or standard as set forth in the this Agreement, including but not limited to the Active Pharmaceutical Ingredient Specifications.

  • In the event Pfizer notifies Xxxxxxx that the API shipment does not conform to the Active Pharmaceutical Ingredient Specifications, Xxxxxxx will have the right to confirm such findings at the Facility.

  • If Company determines that such shipment of API conformed to the Active Pharmaceutical Ingredient Specifications, the parties shall submit samples of such shipment to a mutually acceptable independent laboratory for testing.

  • Company further warrants that all specifications including Active Pharmaceutical Ingredient Specifications and Product Specifications Company provided to Hospira shall conform to the appropriate Investigational New Drug Application or New Drug Application Company files with the appropriate Regulatory Authorities.

  • If Company determines that such shipment of API conformed to the Active Pharmaceutical Ingredient Specifications, the parties shall submit samples of such shipment to a mutually acceptable independent laboratory for [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

  • With respect to the failure of the Product to meet Product Specifications (solely where such failure is not as a result of a failure of the API to meet the Active Pharmaceutical Ingredient Specifications), Hospira may, at its option, in place of reimbursing the replacement cost of such API as set forth in Section 5.3 above, provide Company with replacement Product and waive the Product price with respect to (i) the initial non-conforming Product and (ii) the replacement Product.

  • If such independent laboratory determines that the shipment conformed to the Active Pharmaceutical Ingredient Specifications, Hospira shall bear all expenses of shipping and testing such shipment samples.

  • If Company or such independent laboratory confirms that such shipment did not meet the Active Pharmaceutical Ingredient Specifications, Company shall replace, at no cost to Hospira, the portion of the API shipment which does not conform to the Active Pharmaceutical Ingredient Specifications and bear all expenses of shipping and testing the shipment samples.

  • In the event Hospira notifies Company that the API shipment does not conform to the Active Pharmaceutical Ingredient Specifications, Company shall have the right to confirm such findings at Hospira's manufacturing location.


More Definitions of Active Pharmaceutical Ingredient Specifications

Active Pharmaceutical Ingredient Specifications means the detailed description and parameters of the API, as set forth on Schedule 1.2.
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Active Pharmaceutical Ingredient Specifications means the specifications and quality control testing procedures for the Active Pharmaceutical Ingredient set forth in Exhibit 1.2 hereto which conforms to the ANDA for the Product, as amended from time to time by the mutual agreement of the parties hereto.
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Active Pharmaceutical Ingredient Specifications means the detailed description and parameters of the API, as set forth onSchedule 1.2.
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Active Pharmaceutical Ingredient Specifications means the detailed description and parameters of the API set forth on Exhibit 1.2, which specifications may be amended from time to time by Company, subject to Hospira's written consent, such consent not to be unreasonably withheld. [*]
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Related to Active Pharmaceutical Ingredient Specifications

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Contract Specifications means the principal trading terms in CFD (for example Spread, Swaps, Lot Size, Initial Margin, Necessary Margin, Hedged Margin, the minimum level for placing Stop Loss, Take Profit and Limit Orders, financing charges, charges etc) for each type of CFD as determined by the Company from time to time.

  • 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.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • technical specification means, with respect to any Software, the document setting forth the technical specifications for such Software and included in the Statement of Work.

  • 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.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • 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.

  • Manufacturing Site means a location where a manufacturing

  • API means American Petroleum Institute.

  • Manufacturing Process means any process for—

  • 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;

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

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

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

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

  • Functional Specifications means the descriptions of features and functions of the Application as expressly set forth in Quote.

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • Goods Specification means any specification for the Goods, including any related plans and drawings, as set out in the Order or otherwise agreed in writing by Get Living and the Supplier;

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • 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.”

  • Product Specific Terms means the terms applicable to a specific item of Licensed Software as set out in Schedule 2;

  • Service Specifications means the following documents, as applicable to the Services under Your order: