GMP API definition

GMP API means Compound that has been manufactured in accordance with GMP and is suitable as an API for formulation with excipients to produce CTM or Finished Product.
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Examples of GMP API in a sentence

  • As partial consideration for the exclusive licenses set forth in Section 4.1 and 4.2, the obligation of assignment of the Existing IND(s) to PPD provided in Section 2.2, and the obligation of the provision of GMP API and CTM to PPD by ▇▇▇▇▇▇▇ pursuant to Section 3.1, PPD shall pay a one-time, nonrefundable, upfront payment of three million five hundred thousand dollars ($3,500,000) to ▇▇▇▇▇▇▇, within ten (10) business days after the Effective Date.

  • PFIZER shall transfer all outstanding inventories of non-GMP and GMP API for the Compounds to LICENSEE within *** Business Days after the Effective Date, unless subject to a separate written supplies agreement.

  • Agilent agrees to promptly notify Ophthotech of any inspections or actions by a Regulatory Authority which could potentially impact the production or distribution of the GMP API; provided that Agilent shall provide notice to Ophthotech of any such inspection or action that relates to the API or Product testing within [**] hours.

  • The purpose of this Agreement is to clearly define the roles and responsibilities of Agilent and Ophthotech with regard to quality and GMP compliance issues concerning the production of GMP API molecules and the performance of certain Manufacturing and Laboratory Services, including testing of API and Drug Product.

  • If either Ophthotech or Agilent determines that reprocessing or reworking of the GMP API is necessary due to OOS, manufacturing deviation, unmet Specifications, or otherwise, the procedure will be documented and approved by Agilent Chemical Development, Agilent Manufacturing, Agilent QA and Ophthotech QA, provided that Agilent shall not reprocess or rework the GMP API without the prior written consent of Ophthotech.

  • Estimated price and timelines are summarized below: Task 1.1 Process Development […***…] […***…] […***…] Task 1.2 Analytical Development […***…] […***…] […***…] Task 1.3 Preparation of 1.5 kg non-GMP API […***…] […***…] […***…] Task 1.4 Preparation of 1.0 kg GMP API […***…] […***…] […***…] Task 1.5 3-Year GMP Stability Program […***…] […***…] […***…] This proposal is based on information obtained from previous JMPS manufacture of AEOL 10150 and current efforts on behalf of Aeolus at JMPS.

  • As compensation for the Services rendered under this Agreement, the Company shall pay the Consultant a one-time fee of CA$10,000, plus GST (the “Fee”) upon the successful transfer of the Technology to the CMO and the manufacture and release of a GMP API of the Technology.

Related to GMP API

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • API means American Petroleum Institute.

  • 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.

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • Product Specification means the document referred to in: