www.fdanews.com/articles/169618-india-relaxes-stability-data-rules-for-apis-exported-to-europe
India Relaxes Stability Data Rules for APIs Exported to Europe
January 20, 2015
Indian companies that export active pharmaceutical ingredients to the EU can use six months of long-term stability data to show conformity with good manufacturing practices, rather than the previously required 12 months of data.
International Pharmaceutical Regulatory Monitor