Natco Pharma Ltd.

Natco Pharma has received final approval of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the US Food and Drug Administration (USFDA) for generic version of Armodafinil Tablets, 50 mg, 150 mg, and 250 mg. The pharma major and its marketing partner Breckenridge Pharmaceutical, Inc., plan to launch this product in the USA market immediately.

Cephalon (acquired by Teva in 2011) sells Armodafinil 50mg, 150mg, and 250mg Tablets under brand name ‘NUVUGIL’ in the USA market. NUVUGIL is a wakefulness promoting agent for oral administration. According to IMS Health, NUVUGIL Tablets had US sales of approximately $480 million for twelve months ending December 2015.

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.