Considerations when sourcing active pharmaceutical ingredients (APIs) can often be condensed to ones of economy and purity. Here, Dave Elder highlights the importance of defining those attributes that impact final product quality to ensure pharma companies find the best ingredient suppliers.
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The Indian drug company pleaded guilty to concealing and destroying records containing evidence of its Kalyani plant manufacturing drugs in contravention to FDA requirements prior to a 2013 inspection.
Richard Daniell explains why Europe needs a strong pharmaceutical manufacturing base and supply chain to ensure a resilient network.
Active pharmaceutical ingredients (APIs) are primary components in the manufacture of drugs, yet this global market experiences numerous challenges. Regulatory pressure, pricing arbitrages, a shift to digital manufacturing and patents for blockbuster drugs are chief among them, but the COVID-19 pandemic added a further hurdle as governments globally decided to…
Within this in-depth focus are articles explaining the numerous benefits of in vitro human cell-based kidney models to study nephrotoxicity and drug-to-drug interactions as well as discussing the measures taken by API manufacturers to successfully navigate the pandemic and the opportunities this presents.
This issue focuses on whether our vaccine innovation capabilities will prepare us for future outbreaks, how Raman spectroscopy can be used to rapidly detect SARS-CoV-2 and the development of high-throughput glycoanalytics for biopharmaceuticals. Also included are articles on opportunities in the global API market and how to successfully identify defects…
The agency has compiled a list of essential medicines, medical countermeasures and critical inputs, as directed by Trump’s executive order in August.
Solid-state NMR spectroscopy is an effective technique for the analysis of both crystalline and amorphous pharmaceuticals, both in the drug substance and drug product. In this article, Eric Munson provides an overview of the technique and how it applies to pharmaceutical analysis.
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…
The impact of COVID-19 is wide-reaching with disruptions to supply chains likely to continue over the coming years. In this article, Dave Elder discusses the effect of the pandemic on the supply and demand of critical medicines and what this means for pharma supply chains.
Hosted online from 11 – 12 November, Chemspec Digital 2020 provides an interactive networking event for the fine and speciality chemicals community. From all over the world, industry experts will have the opportunity to meet, conduct business, discover innovative substances and learn about the latest trends and developments.
Liquid-filled hard capsules: A flexible tool for rapid access to the clinic with poorly soluble and/or highly potent compounds
21 October 2020 | By Lonza Pharma & Biotech
Watch our on-demand webinar to learn about liquid-filled hard capsule technology has a proven record for addressing complex active pharmaceutical ingredient (API) formulation challenges, including bioavailability enhancement.
In this in-depth focus experts provide guidance on how to select starting materials for API's and discuss how to specify exipients to reduce downstream regulatory burdens.