White Paper: Top 12 Recent Global API Regulatory Developments
Published April 2022
Abstract:
This white paper looks at what an active pharmaceutical ingredient (API) is, documents related to APIs, API regulations, and recent API regulatory changes made between 2020 and 2022.
Keywords: sterile API, API regulations, regulatory changes, FDA, Health Canada, EMA, ANVISA, pharmacopoeia, cGMP API manufacturing, ICH, nitrosamine impurities, RTEMIS
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