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 Xxxxxxx 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 Xxxxxxx, within ten (10) business days after the Effective Date.

  • If Xxxxxxx terminates this Agreement under Section 10.2, (i) any and all licenses granted to PPD by Xxxxxxx pursuant to Sections 4.1 and 4.2 shall terminate and (ii) PPD shall, to the extent requested by Xxxxxxx in writing, (1) assign and transfer to Xxxxxxx all right, title, and interest in all quantities of GMP API, CTM, and Finished Product in PPD’s control and all Regulatory Filings, Regulatory [*] Confidential treatment requested; certain information omitted and filed separately with the SEC.

  • Expect at least 12 months for the development and manufacture of drug product for a clinical trial and 6–12 months for the manufacture of GMP API.

  • Ground broadcast applications may result in exposure on foliar dietary items from spray drift, and are thus characterized, but aerial applications are only available for granular products and therefore are not analyzed for spray drift.

  • 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.

  • In total, about fty functions from the GMP API are exported by WhyMP.

  • ADB selected the international consultants in June 1994, but could not finalize a contract until PWD had appointed the domestic company.

  • The education program, GDUFA II and GMP API Inspection Trends: The Business Impact of Upcoming Regulatory Changes, will provide the business impact of key regulatory changes in the US and European Union impacting pharmaceutical manufacturing and the supply chain.

  • We propose to augment the utilities for our Bavla facility to meet and balance the increasing demand of the proposed GMP API pl ant, GMP Intermediate plant and the expansion of the existing facilities, of various utilities and services.

  • The Company will also increase marketing and sales activities to provide this GMP API to pharmaceutical companies internationally.

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.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Product Specifications means those product, labeling and performance specifications for the Product filed with and approved by the relevant Regulatory Authority, including Product formulae, labeling, and materials required for the manufacture of the Product that is to be purchased and supplied under this Agreement, as such are set forth on Schedule 1.25, which specifications may be amended by the Parties from time to time in accordance with this Agreement.

  • 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.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Manufacturing Process means any process for—

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • GMPs means the then-current good manufacturing practices required by the FDA, as defined in 21 C.F.R. Parts 210 and 211 and the regulations promulgated thereunder, for the manufacture and testing of pharmaceutical materials, and comparable laws or regulations applicable to the manufacture and testing of pharmaceutical materials in jurisdictions outside the U.S., as they may be updated from time to time. GMPs shall include applicable quality guidelines promulgated under the International Conference on Harmonization.

  • cGMPs means, as applicable, current good manufacturing practices as described in:

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

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • 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.

  • Free product means a contaminant that is present as a non-aqueous phase liquid for chemicals whose melting point is less than 30° C (e.g., liquid not dissolved in water).

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Contract Specifications means the principal trading terms in CFD (for example Spread, Swaps, Lot Size, Initial Margin, Necessary Margin, Hedged Margin, the minimum level for placing Stop Loss, Take Profit and Limit Orders, financing charges, charges etc) for each type of CFD as determined by the Company from time to time. The Contract Specifications appear on the Website.