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Gilead to support Indian COVID-19 crisis with donation of remdesivir
The company will donate 450,000 vials of remdesivir and support its licencing partners in expanding and accelerating the production of the drug.
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Active Pharmaceutical Ingredient (API)
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Case study: Finding impurities and controlling formations at release
Case study example regarding finding impurities and controlling formations at release.
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Collaboration to encourage US adoption of continuous manufacturing
USP and Phlow have built a new laboratory to develop test methods and standards to facilitate broader adoption of continuous manufacturing in the US.
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Optimising spray-dried solid dispersions to improve solubility
Manufacturing drug products with low solubility APIs (BCS type II and IV) has its challenges, in this article, Javier Gurrea, a Spray Drying Manufacturing Scientist at Idifarma, explains why spray drying offers a great way to overcome them.
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Sourcing of active pharmaceutical ingredients
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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Chemspec Europe 2021 postponed
The 35th International Exhibition for Fine and Speciality Chemicals will now take place as live and digital hybrid event from 29 to 30 September 2021.
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Fresenius Kabi Oncology Ltd to pay $50mn for destroying records ahead of an FDA Inspection
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.
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EC Pharma Strategy: the first steps towards a more sustainable industry?
Richard Daniell explains why Europe needs a strong pharmaceutical manufacturing base and supply chain to ensure a resilient network.
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New opportunities for the global API market
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…
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Formulation, Development & Delivery In-Depth Focus 2020
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.
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European Pharmaceutical Review Issue 6 2020
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…
webinar
How to master raw material ID testing in 2021
11 November 2020 | By Thermo Fisher Scientific
In this on-demand webinar we explore the evolving role of handheld and portable instruments to drive quality improvements and manufacturing success in 2021.
news
FDA publishes list of essential medicines and medical countermeasures
The agency has compiled a list of essential medicines, medical countermeasures and critical inputs, as directed by Trump’s executive order in August.
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Solid-state NMR spectroscopy of drug substances and drug products
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.
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Approval of regulatory starting materials
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…
