“The FDA is becoming more stringent. It’s a learning curve for everyone. You have to invest more,” said B&K Securities analyst Rohit Bhat. “Companies will have to pull up their quality parameters.”continue to read here
Saturday, March 29, 2014
FDA Crackdown in India Leads to Bans on Imports
New U.S.-imposed regulations meant to improve quality have forced Indian pharmaceutical manufacturers to make adjustments. The pressure for those changes has proved to be too cumbersome for one Gujarat-based facility owned by Sun Pharmaceuticals. The largest drug manufacturer in India will no longer be able to export the same high volume to the world’s largest drug market, after the U.S. Food and Drug Administration forced the stop.