API Development: 5 Critical Mistakes to Avoid

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API

Approximately less than ten percent of drug development programs successfully reach the commercial marketplace. Most organizations strive to produce as many effective compounds as possible to increase the chances of commercialization. In order to avoid major challenges later during commercial scale-up, personnel from Development, Manufacturing, Quality Control and Quality Assurance should be aware of critical mistakes that can occur during the early development phase.

Learn more about these challenges from this article at Pharmaceutical Online.

August 10, 2018 FDA Warning Letter to Kyowa Hakko Bio Co., Ltd.: Failure to ensure the API manufactured at the above-mentioned facility are in compliance with CGMP