API Batch(es) definition

API Batch(es) means the batches of active pharmaceutical ingredient AT-001produced under the [***] entered into between [***] and Aratana [***]. 
Sample 1
API Batch(es) means the quantity of active pharmaceutical ingredients produced per batch(es) actually produced by FibroGen’s then-current manufacturer.
Sample 1

Examples of API Batch(es) in a sentence

  • Impurity profiles have been established for the existing API Batches selected for retrospective validation should be representative of all batches produced during the review period, including any batches that failed to meet specifications, and should be sufficient in number to demonstrate process consistency.

  • API Batches included in this initial API Rolling Forecast shall be governed under this Agreement and considered as having conformed to API lead time requirements as set forth in Section 3.3.4.

  • For the finished Products released to Elanco that were manufactured from the API Batches, (i) the Adjusted API Price shall apply for the finished Product and (ii) Aratana will invoice Elanco for the finished Products in accordance with the Term Sheet except for the price adjustment reflected in (i) above, and such invoice will include a prorated credit for the prepaid API.

  • An initial [***] rolling quarterly forecast of the quantity and size of API Batches AMICUS desires WUXI BIOLOGICS to Deliver API is provided in Appendix B.

  • There were no previous results in this direction for this class of tensors.

  • To authorize the purchase of furniture for the Health Professions Building from KI Inc.

Related to API Batch(es)

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Harvest batch means a specifically identified quantity of dried flower or trim, leaves, and other cannabis plant matter that is uniform in strain, harvested at the same time, and, if applicable, cultivated using the same pesticides and other agricultural chemicals, and harvested at the same time.

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

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

  • API means the American Petroleum Institute.

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

  • 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.

  • 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.

  • 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.

  • Finished Products means the fully assembled and shrink-wrapped Licensed Products, each including a Game Cartridge, Game Cartridge label and Printed Materials.

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Inert ingredient means an ingredient which is not an active ingredient.

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

  • Product Specifications means those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

  • 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.

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

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Manufacturing Process means any process for—

  • Shipment means a volume of products offered to and accepted by Carrier for transportation.

  • cGMPs means current good manufacturing practices as described in Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations together with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Active Ingredient means the clinically active material(s) that provide pharmacological activity in a pharmaceutical product (excluding formulation components such as coatings, stabilizers, excipients or solvents, adjuvants or controlled release technologies).

  • labelling means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food;

  • shipped includes removal from the work sites by ship or any other means;

  • Batch Record means the production record pertaining to a Batch.