Active Pharmaceutical Ingredients

EC API regulations plan get mixed pharma response

Mixed response to EC plan to extend Directive 2003/94/EC to APIs

By Gareth Macdonald

The EC plan to extend drug GMP guidelines to APIs has met with a mixed response from industry groups, drugmakers and API manufacturers with some - like DSM and CEFIC – asking for clarification on the future of EudraLex Volume 4 Part II.

AAPS - round up of day one

AAPS - round up of day one

By Nick Taylor

Following the first full day of AAPS 2009 in Los Angeles, California, US we take a look at the major developments and talking points.