Why ‘Made in China API’ Is Becoming a Liability Line on Regulatory Filings

Pharmaceutical companies source raw materials, including active pharmaceutical ingredients (APIs) and key intermediates, through qualified suppliers who meet regulatory purity standards, documented manufacturing controls, and traceable supply chains, often spanning multiple countries. A growing share of buyers are now actively diversifying away from single-country sourcing, particularly heavy reliance on Chinese API manufacturing, due to geopolitical
- Published in Pharmaceutical Quality Assurance
The API Recalls That Are Making Quality Audits a Boardroom Topic, Not Just a QA One

Pharmaceutical companies rely on layered systems that include raw material qualification, in-process testing, validated manufacturing controls, and independent quality audits at every stage of production, all governed by frameworks like current Good Manufacturing Practice (cGMP). Following a wave of high-profile API contamination recalls, these quality systems have moved from a back-office compliance function into a
- Published in Pharmaceutical Quality Assurance




