Keyword: Abbreviated New Drug Application (ANDA)
News
11.09.2015
- Following approval from the US Food and Drug Administration (FDA), Netherlands-domiciled Mylan has launched generic copies of Bayer's drospirenone and ethinyl estradiol-based...
News
28.08.2015
- US pharma company Alvogen has agreed to buy four of Pfizer’s products in the USA. The sale is part of Pfizer’s condition in closing its $17 billion acquisition of Hospira. The...
News
10.04.2015
- The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) from Shire for its lifitegrast dry eye treatment for adults and has designated it as a Priority...
Plant Construction & Process Technology
02.04.2014
- The Price of Doing Business - Following the 2012 implementation of the Generic Drug User Fee Act (GDUFA), an article in CHEManager Europe's July/August 2013 edition about GDUFA's...
Plant Construction & Process Technology
06.08.2013
- One-Time Fee - On Oct. 1, 2012, the U. S. Food and Drug Administration (FDA) implemented the long-discussed Generic Drug User Fee Act (GDUFA) , thereby authorizing the agency to...
Plant Construction & Process Technology
19.10.2011
- Paradigm Shift - The number of API manufacturers in India and China focused on supplying active ingredients to regulated markets has grown considerably over the past few years...
