Day: February 4, 2016

In the year 2015, FDA approved the largest number of new drugs and biologics ever; 45 new drugs and biologics were approved. One third or 36% of these new products were first in class drugs meaning that they had novel mechanisms of action and were chemically and biologically different from any drugs approved in the … Read more

India and China have similar number of FDA-registered GMP manufacturing sites, 662 and 694, respectively. India and China manufacture similar kind of regulated products, primarily API and finished drug products, and very few biologics and medical devices. The two countries are culturally and economically quite similar as well. However, manufacturing sites in China have received … Read more