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Quality Agreement Template (Generic APIs)Quality Agreement • July 28th, 2020
Note 0.1: the term “generic API” is used in this template for all APIs that in principle can be obtained from multiple sources, or are manufactured and supplied to multiple customers, as opposed to APIs that are sold only by the originator company or its exclusive licensees. Such generic APIs are off-patent; they are usually described in pharmacopoeial monographs, and supplied based on standard specifications.
