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New markets for drug manufacturers are emerging worldwide in regions that have typically purchased and imported drugs in finished dosage forms. While this shift has been underway for a few…
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 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…
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.
Consistent – Yet Still Low – Clinical Success Rates The number of drug candidates which are approved, get to market and subsequently become profitable for industry is pretty low. And…
We’ve recently written extensively about nitrosamine impurities, including this in-depth analysis of what transpired with Valsartan, and some follow-up material, here and here. Nitrosamine impurities have been receiving a great…
Confused by the new FDA CDER Site Selection Model? Here’s what you need to know. CDER – the U.S. FDA’s Center for Drug Evaluation and Research which regulates over-the-counter and…
Peptide process development projects have increased in the last few years. Judging by our blog readership and social interactions, interest in peptide drugs is continuing to grow by leaps and…
