Natco Pharma Ltd.

Natco Pharma has filed Abbreviated New Drug Applications (ANDAs) for Fingolimod, 0.5mg Capsules & Cabazitaxel, 60mg/1.5ml Injection, with the US Federal Drug Administration (US FDA), through its respective marketing partners in the USA.

Natco & its associated marketing partners, for the above products in the USA, are the first company to have filed a substantially complete ANDA which includes a paragraph IV certification for Fingolimod, 0.5mg Capsules & Cabazitaxel, 60mg/1.5ml Injection, providing 180 days of marketing exclusivity upon its final US FDA approval.

Novartis sells Fingolimod 0.5mg Capsules under Brand name Gilenya, in the USA market and used for the treatment of certain patients with multiple sclerosis. The market size of Gilenya in the USA is around $1.2 billion for twelve months ending September 2014.

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.