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Active Pharmaceutical Ingredient (API)

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webinar

How to master raw material ID testing in 2021

11 November 2020 | By Thermo Fisher Scientific

In this webinar taking place on 9 December, we explore the evolving role of handheld and portable instruments to drive quality improvements and manufacturing success in 2021. Reserve your free virtual seat today!

article

Approval of regulatory starting materials

27 October 2020 | By

There are significant interpretational differences between the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)’s guidance on active pharmaceutical ingredient (API) starting materials. In this article, Dave Elder explores the ambiguity in guidance from both agencies and addresses why industry struggles to identify and justify starting materials…