API manufacturer definition

API manufacturer means a person, other than the holder of a manufacturer's licence, engaged in the manufacture or assembly of active substances used as starting materials in the manufacture of medicinal products;
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Examples of API manufacturer in a sentence

  • All shipments of API will be accompanied by certificate(s) of analysis from the API manufacturer including confirmatory results demonstrating that the API complies with the manufacturer’s API specifications.

  • Within ninety (90) days of the Effective Date, the parties shall execute a quality agreement (“Quality Agreement”), which sets out the responsibilities of the parties in connection with the (i) API as they are related to quality control and quality assurance and (ii) the compliance with the European Union’s GMP regulation requiring the GMP status of the API manufacturer to be assured by the marketing authorization holder or the final product manufacturer.

  • During the Agreement's Term, Hovione shall be Allos' primary API manufacturer and Allos and its affiliates and licensees shall purchase no less than the percentages set forth in this Term Sheet of its RSR13 sodium salt requirements from Hovione, subject to their supply capacity and conformance with the Agreement.

  • Without prejudice to the generality of the foregoing, Supplier undertakes to seek to *** from the ***, *** as an API manufacturer for the USA, Europe and other markets, to pass any regulatory inspection and undertakes to continuously satisfy all the relevant necessary regulatory requirements and maintain a *** to the cGMP regulations (FDA, EU and other markets) for the purposes of maintaining such regulatory approval.

  • API ordered by UMAN will be delivered to the UMAN facility with a certificate of analysis from the API manufacturer.

  • This document offers best industry practice and guidance in the establishment of a Quality Agreement between an API manufacturer and its contract laboratory.

  • During the Agreement's Term, Hovione shall be Allos' primary API manufacturer and Allos and its affiliates and licensees shall purchase no less than the percentages set forth in this Term Sheet of its [ * ] from Hovione, subject to their supply capacity and conformance with the Agreement.

  • Technology Transfer Fee–Production Fee” on [ * ] manufactured by each such new API manufacturer.

  • Without prejudice to the generality of the foregoing, Supplier undertakes to seek to obtain approved supplier status from the FDA, EMEA and every local competent authority as an API manufacturer for the USA, Europe and other markets, to pass any regulatory inspection and undertakes to continuously satisfy all the relevant necessary regulatory requirements and maintain a “state of conformity” to the cGMP regulations (FDA, EU and other markets) for the purposes of maintaining such regulatory approval.

  • Such access shall be subject to Stason entering into a reasonable and appropriate confidentiality agreement with such API manufacturer, which Developers shall facilitate.