Active Pharmaceutical Ingredients definition

Active Pharmaceutical Ingredients or “API” means the materials listed in a Product Agreement on Schedule D;

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Active Pharmaceutical Ingredients or “APIs” shall mean chemicals used in the manufacture of drugs and do not include intermediates used in the manufacture of such chemicals.

Active Pharmaceutical Ingredients or “API” shall mean bulk, unformulated Calcitriol.

Examples of Active Pharmaceutical Ingredients in a sentence

The Parties acknowledge that production of pharmaceutical products is inherently complex and requires close attention to all aspects of the Specifications, Excipients, Active Pharmaceutical Ingredients, production, storage, and shipment (collectively, “Process Requirements”).
Both Supplier and Company shall ensure that manufacturer of Active Ingredient complies with ICH Q7 Guideline, Good Manufacturing Practice for Active Pharmaceutical Ingredients.
On receipt of the API and Client supplied Components, B▇▇▇▇▇’▇ sole obligation with respect to evaluation of the API and Client supplied Components shall be to review the accompanying Certificate of Analysis to confirm that the Active Pharmaceutical Ingredients and Client supplied Components (if applicable) conform with the specifications.
Except as provided for in this Clause 12 or as provided for in the License Agreement or Supply Agreement, Novartis makes no representations, extends no warranties of any kind, either express or implied, and assumes no responsibility after Closing whatsoever in respect of the Business, the Transferred Assets, the manufacture, marketing, promotion, distribution, sale and use of the Product or the Active Pharmaceutical Ingredients and the Licensed Assets.
All manufacture and supply of API will be performed in accordance with current Good Manufacturing Practices and the International Conference on Harmonization (ICH) Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

More Definitions of Active Pharmaceutical Ingredients

Active Pharmaceutical Ingredients or “API” shall mean the active pharmaceutical ingredients for the Product as set forth on Exhibit 3 attached hereto, including the specifications and the analytical methodology related thereto, as such specifications may be amended from time to time by mutual agreement of the Parties.

Active Pharmaceutical Ingredients or “API” means coagulation factor IX (recombinant) drug substance;

Active Pharmaceutical Ingredients means the active ingredient halometasone and the active ingredient triclosan that are contained in the Product and set forth in Annex 4.

Active Pharmaceutical Ingredients means the chemical compound identified by DAIICHI SANKYO’s code number: DJ-927, also known as tesetaxel, whose chemical name is: (*)

Active Pharmaceutical Ingredients or “API” shall mean the bulk active drug substances.

Active Pharmaceutical Ingredients means chemicals, substances, or other components of articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases in humans or animals or for use as nutritional supplements.

Active Pharmaceutical Ingredients means any substance that is intended for incorporation into a finished drug product and 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 body.