Industry

Making a case for GMP certification of an excipient manufacturer should be a straightforward exercise since the benefits appear so clear cut and regulatory guidance in the EU underscores the value of certification. Specifically, Chapter 3 of the EMA Guidance on formalised risk assessments to determine the appropriate GMP for a pharmaceutical excipient states that […]

U.S. policy discussions include tariff rates reportedly up to triple digits on certain imported finished drugs. While details are evolving, any broad measure would ripple back to API and KSM sourcing, potentially lifting prices and re-routing orders. Why it matters for API trade• Buyers may front‑load Q4 purchases to hedge against cost increases.• Preference could

The EU Council adopted its negotiating position on the first major overhaul of pharmaceutical legislation since 2004. The package targets faster access, competitiveness and incentives (notably for antimicrobials), alongside obligations on supply continuity and environmental risk. Why it matters for API trade• Stronger expectations for shortage prevention plans and notification lead‑times.• Potential impact on data

As the pharmaceutical sector accelerates into a post-pandemic era, the global API market is expected to reach unprecedented levels. Rising healthcare demands in emerging markets, the growth of biologics, and a strong generics pipeline are creating exciting opportunities for API manufacturers. However, challenges such as geopolitical uncertainty, stricter environmental regulations, and increased scrutiny from regulatory

In the current pharmaceutical ecosystem, a delayed delivery or compromised batch can cost millions and damage credibility. This is why supply-chain reliability has become a critical driver of success rather than a back-end function. Companies that collaborate with consistent API partners enjoy guaranteed production timelines, predictable costs, and smoother regulatory processes. Such reliability allows marketing