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A significant paradigm shift is underway in the regulatory environment for impurities in pharmaceutical products. Recent incidents involving genotoxic impurities (GTIs) are driving tighter restrictions and guidelines, as well as…
The need for API manufacturers to establish strong quality systems and plan for business continuity has never been greater than it is today. And you can probably guess the reason…
The global market for active pharmaceutical ingredients (APIs) is expected to grow at a 3–6% Compound Annual Growth Rate (CAGR) over the next five years, exceeding U.S. $1.5 trillion by…
Seven years ago – in March of 2013 – we published a blog post on 5 Things to Consider When Looking for an API Supplier. Because seven human years equals…
Around the world, pharma and biopharma – along with all of the supporting industries, from suppliers and research organizations to outsourced providers – have been exclusively focused on COVID-19. With…
In December 2019, China issued a revision to their Drug Administration Law. It was the most wide-ranging modification of their laws since 2001. It marked a fundamental shift away from…
Drug quality and strong analytical capabilities go hand-in-hand. It is virtually impossible to achieve the former without the latter at all stages of a drug’s development and production.
The basic principle of pharmaceutical quality assurance is that a drug should be safe and effective for its intended use – and process validation plays a pivotal role in ensuring…
Coronavirus has impacted drug supply chains. At first blush, people will likely read that sentence to mean drugs aren’t arriving at their intended destination. That precursor chemicals, intermediaries, APIs, or…
The outbreak of COVID-19 has significantly impacted physical visits to drug manufacturing facilities. This raises a number of challenges, since many regulations — especially those relating to inspections — weren’t written with…
