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.

  • The Association will be supplied with the names and addresses of new hires in permanent full-time and permanent part-time positions.

  • Within [**] after the date that a Purchase Order is submitted, Ercros shall acknowledge receipt of Zavante’s Purchase Order and confirm that the amounts of API Mixture ordered in the Purchase Order, subject to Section 4.3, will be timely supplied.

  • Title to the API Mixture and risk of loss, delay or damage in transit for API Mixture purchased by Zavante shall pass to Zavante when a shipment of the Product is placed at the disposal of Zavante’s carrier at the Facility.

  • Ercros will supply on an annual basis and at no cost to Zavante, all data regarding the API Mixture in its control, including release test results, complaint lest results, and all investigations (in manufacturing, testing, and storage), that Zavante reasonably requires in order to complete any filing under any applicable regulatory regime, including any Annual Product Review Report that Zavante is required to file with the FDA or any other Regulatory Authority.

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

  • 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 [**] 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.

  • Such notices shall not operate to relieve Ercros of their obligations to deliver the ordered amounts of API Mixture or affect Zavante’s right to pursue any remedies that might be available to it.

  • Without limiting the generality of the foregoing, Ercros will supply to Zavante, as soon as possible, sufficient quantities of API Mixture to enable Zavante to support the filing of one or more NDAs for the Product, referencing Ercros as its supplier of API Mixture, and letters authorizing Zavante to exclusively (even with respect to Ercros) reference the DMF in the NDAs and other regulatory submissions for the Product in the Territory.

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.

  • combustible waste ’ means non-biodegradable, non- recyclable, non-reusable, non-hazardous solid waste having minimum calorific value exceeding 1500 kcal/kg and excluding chlorinated materials like plastic, wood pulp, etc.;