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 “API” shall mean bulk, unformulated Calcitriol.

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.

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”).

• 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.

• Both Supplier and Company shall ensure that manufacturer of Active Ingredient complies with ICH Q7 Guideline, Good Manufacturing Practice for Active Pharmaceutical Ingredients.

• Upon receipt (if applicable) of a list of audit observations, PCAS shall take corrective action in accordance with Good Manufacturing Practice (i.e., ICH Q7a Good Manufacturing Guidance for Active Pharmaceutical Ingredients) and state the timeframe involved and the persons responsible for taking such corrective action.

• Barrier will prepare, obtain, and maintain all necessary import and export registrations relating to the Product and the 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 or “API” has the meaning ascribed to it in the License Agreement.

Active Pharmaceutical Ingredients or “API” shall mean the sanofi-aventis API and the Horizon API.

Active Pharmaceutical Ingredients means the chemical compound identified by Daiichi Sankyo’s code number: DJ-927, also known as tesetaxel, whose chemical name is: (-)-(1S,2S,3R,4S,5R,8R,9S,10R,13S)-4-acetoxy-2-benzoyloxy-9,10-1(1S)-2-(dimethylamino)-ethylidenedioxyl-5,20-epoxy-1-hydroxytax-11-en-13-y1(2R,3 S)-3-(tert-butoxycarbonylamino)-3-(3-fluoro-2-pyridyl)-2-hydroxypropionate. Table of Contents

Active Pharmaceutical Ingredients or “API” shall mean the active pharmaceutical ingredients for each Product, as set forth in the respective Product Addendum in ANNEX 1.