API Raw Materials definition

API Raw Materials means all raw materials, supplies, components and packaging necessary to manufacture the API in accordance with the API Specifications and API Master Production Record.
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Examples of API Raw Materials in a sentence

  • NuPathe shall be responsible for surveillance, receipt and evaluation of all product complaints concerning the NuPathe Patch in accordance with all laws and regulations applicable in the countries where NuPathe, its Affiliates or sub-licencees market the NuPathe Patch; provided, however, that each Party shall promptly advise the other of any safety or toxicity problem of which either Party becomes aware regarding the Drug Product, API, Raw Materials or the NuPathe Patch.

  • CEPH shall procure all API, Raw Materials and other components for Products in accordance with the ANDA as approved by the FDA.

  • Current inventory of API, In-Process API, Raw Materials, safety stock and reference standards.

  • Lonza shall maintain and keep Final Product, API Raw Materials, Intermediate and other Customer Materials in its care secure and safe from loss and damage in such manner as Lonza stores its own material of similar nature.

  • DSM shall utilize only those suppliers of API, Raw Materials, or other items for the Manufacture of Product hereunder approved by AAI.

  • For the avoidance of doubt, Lonza will invoice API Raw Materials only for the amount of Final Product manufactured.

  • Supplier shall not make any changes to the process, API, Raw Materials, supply sources, Specifications, manufacturing locations or facilities used to make Product for Zogenix under this Agreement, including, without limitation, any such changes that may require Zogenix to provide notification to regulatory authorities, without the prior written consent of Zogenix.

  • Customer shall place a binding Purchase Order for API Raw Material that is necessary for the requested Final Product, [***] ahead of the Commencement Date in accordance with Clause 8.1. However, Customer may vary the Campaign size and timing for API manufacture within the Facility with [***] written notice, subject only to availability of Intermediate inventory and any API Raw Materials in excess of the quantity of the Purchase Order.

Related to API Raw Materials

  • 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.

  • Raw Material means any unprocessed material in its raw or natural state that is intended to become part of the components of a cannabis product.

  • 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.

  • 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:

  • API means American Petroleum Institute.