API Mixture definition

API Mixture means a blend of fosfomycin sodium and succinic acid to obtain intravenous quality, according to the API Mixture Specifications.
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API Mixture means the blend of fosfomycin sodium and succinic acid intended for use in preparing an intravenous formulation purchased by Zavante from Ercros.
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Examples of API Mixture in a sentence

  • This objective will be supported by the delivery to Zavante from Ercros and ERN of technical documentation, expertise and know-how for the API and API Mixture, and regarding Product manufacturing.

  • As used herein, the term, “Recall” includes any action (i) by Zavante to recover title to or possession of quantities of the API Mixture or the Product sold or shipped to Third Parties (including, without limitation, the voluntary withdrawal of Product from the market); or (ii) by any Regulatory Authorities to detain or destroy any of the API Mixture and/or the Product.

  • Within [**] following the execution of this Agreement, the Parties shall in good faith negotiate and execute a Quality Agreement concerning the API Mixture (the “Quality Agreement”).

  • In the event that Ercros receives any complaint, claims or adverse reaction reports regarding API Mixture, including notices from the FDA regarding any alleged regulatory non-compliance of API Mixture, Ercros shall promptly and not more than [**] after receipt, provide to Zavante all information contained in the complaint, report or notice and such additional information regarding API Mixture as Zavante may reasonably request.

  • All of the reports data and information regarding sales of the Product and purchases of the API Mixture shall be Confidential Information of Zavante.

  • Within [**] after the end of each calendar year, Fisiopharma will prepare an annual reconciliation of API Mixture on the reconciliation report form including the calculation of the “Actual Annual Yield” or “AAY” for the Bulk Drug Vials during the calendar year.

  • The Purchase Order shall set forth the quantities of API Mixture desired, the desired delivery date and the desired destination for delivery.

  • Recall will also include any action by either Party to refrain from selling or shipping quantities of the API Mixture and/or the Product to Third Parties which would have been subject to a Recall if sold or shipped.

  • YOY growth Figure 1.2: EU fresh-cut fruit and vegetables market compared to other fruit and vegetables segments, 2005-2014f volume growth (f=forecast).

  • Ercros will be solely responsible for maintaining the DMF and all other regulatory filings and for conducting any other compliance efforts related to manufacturing the API Mixture that are required in order to obtain approval from the FDA of Zavante’s NDAs referencing the DMF and the API Mixture, at no additional cost to Zavante.

Related to API Mixture

  • Oily mixture means a mixture with any oil content.

  • Mixture means a mixture or solution composed of two or more substances;

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

  • Chemical agent shall mean any compound which, when suitably disseminated, produces incapacitating, damaging or lethal effects on people, animals, plants or material property.

  • Semisolid means a product that, at room temperature, will not pour, but will spread or deform easily, including but not limited to gels, pastes, and greases.

  • Radionuclide means a radioactive element or a radioactive isotope.

  • 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.

  • Radioactive Products or Waste means any radioactive material produced in, or any material made radioactive by exposure to the radiation incidental to the production or utilisation of nuclear fuel, but does not include radioisotopes which have reached the final stage of fabrication so as to be usable for any scientific, medical, agricultural, commercial or industrial purpose.

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

  • Isomer means all enantiomers and diastereomers.

  • Radioactive waste means radioactive waste as defined in Article 3(7) of Council Directive 2011/70/Euratom8;

  • Feed ingredient means each of the constituent materials making up a commercial feed.

  • Contaminant means any material, substance or waste that is classified, regulated or otherwise characterized under any Environmental Law as hazardous, toxic, a contaminant or a pollutant or by other words of similar meaning or regulatory effect, including any petroleum or petroleum-derived substance or waste, asbestos and polychlorinated biphenyls.

  • 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).

  • Substances means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

  • 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.

  • Cannabinoid extract means a substance obtained by separating cannabinoids from marijuana by:

  • Oxides of nitrogen means the sum of the volume mixing ratio (ppbv) of nitrogen monoxide (nitric oxide) and nitrogen dioxide expressed in units of mass concentration of nitrogen dioxide (μg/m3);

  • Hydrofluorocarbons means compounds that only contain hydrogen, fluorine, and carbon.

  • Chemicals means substances applied to forest lands or timber including pesticides, fertilizers, and other forest chemicals.

  • Nitrogen oxides means nitric oxide and nitrogen dioxide, expressed as nitrogen dioxide (NO2);

  • Beam scattering foil means a thin piece of material (usually metallic) placed in the beam to scatter a beam of electrons in order to provide a more uniform electron distribution in the useful beam.

  • Cannabinoid concentrate means a substance obtained by separating cannabinoids from marijuana by:

  • Soil texture means proportion by weight of sand, silt, and clay in a soil.

  • API means the American Petroleum Institute.

  • Diesel means a distillate oil which can be used as fuel for the operation of a compression ignition engine and which has an approximate boiling temperature of between 150 °C to 400 °C;