API Manufacturing Process definition

API Manufacturing Process is defined as a process used in the manufacture of API of such a type that a change in such process would require approval by the FDA or other Regulating Groups in the Territory in order to market, sell and distribute the Product in the Territory.
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API Manufacturing Process will have the meaning set forth in Section 8.2.
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Examples of API Manufacturing Process in a sentence

  • Cadence will reimburse B▇▇▇▇▇ for all reasonable costs incurred by B▇▇▇▇▇ directly related to B▇▇▇▇▇ work performed in support of such API source or API Manufacturing Process change, including but not limited to the cost of new stability studies, submissions to the FDA and any other Regulating Groups and return of unused (if any) API from the prior source or manufactured under prior API Manufacturing Processes.

  • By way of example, additional work might be required for Product or process changes requested by the FDA or other Regulatory Authorities, API source changes or API Manufacturing Process changes, USP or other regulatory requirements changes, excessive or untimely requests by EKR for label changes or recalls or other actions by Regulatory Authorities, or mutually agreed upon expansion of the Territory.

  • EKR will be responsible for requesting approval by the FDA and all other Regulatory Authorities in the Territory for such change in API or API Manufacturing Process.

  • EKR will use commercially reasonable good faith efforts to inform ▇▇▇▇▇▇ in writing at least two (2) years in advance of any change in its API source, or any change in its API Manufacturing Process if such change would require approval by the FDA or other Regulatory Authorities in the Territory.

  • Cadence will neither change its API source nor any API Manufacturing Process unless and until such change is approved by the FDA and all other Regulating Groups in the Territory for the Product.

Related to API Manufacturing Process

  • Manufacturing Process means any process for—

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • 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;

  • 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.