There is an urgent need for more trained professionals who understand and are able to apply international regulatory standards. Courses at ASU prepare our students to operate under strict international regulatory norms. Recently many Indian manufacturing units are falling afoul of the US-FDA drug regulations. The latest to do so is the Indian subsidiary of the Canadian drug company Apotox.
WASHINGTON (Reuters) - An Indian subsidiary of Canadian drug company Apotex Inc manipulated laboratory data, retesting samples until the results were acceptable, according to a warning letter posted by the U.S. Food and Drug Administration on its website on Tuesday.