Pharmaceutical & Biotech

Integrity and Quality Problems Continue to Plague India's API Manufacturers, an Industrial Info Market Brief

India has long been a major active pharmaceutical ingredients (APIs) supplier, second only to China. Some analysts predict the APIs market will be worth $185.9 billion by 2020. Growth is often accompanied by problems, and for India, it isn't just competitors as other countries get in on the action. Repeated regulatory citations concerning manufacturing standards are driving some customers away. Each new citation seems to draw even more intense scrutiny from the FDA. John Nason from TAPI said, 'Looking at statistics from the past five years, the number of API suppliers to come under scrutiny by the U.S. FDA has increased. We see that quality concerns in hubs such as China and India have prompted the U.S. FDA to more closely scrutinize manufacturers in Asia-Pac. There is greater regulatory focus on impurity profiles, which requires more analytical and characterization methods.'

Released Monday, August 19, 2019