Integrity and Quality Problems Continue to Plague India's API Manufacturers, an Industrial Info Market Brief
Integrity and Quality Problems Continue to Plague India's API Manufacturers, an Industrial Info Market Brief
Attachment: india
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."
Subscribe Now!(All Fields Required)
Related Articles
Articles related to this company
- Mexico Registers US$2 Billion in Pharmaceutical Investments
- New England Sees $27 Billion in Projects Under Construction
- Pharma, Manufacturing Lead Indiana to $21.6 Billion of Projects Under Const...
- India Aims to Reduce Dependence on China for Pharma Market
- BMS Investing $400 Million in Dublin Sterile Drug Expansion