Natco Pharma Ltd.

Natco Pharma’s marketing partner, Mylan Inc., has received a tentative approval for its Abbreviated New Drug Application (ANDA) for Sorafenib Tablets, 200mg, with the US Food and Drug Administration (USFDA). This product is the generic version of NEXAVAR, which is indicated for the treatment of certain types of cancers including unresectable hepatocellular carcinoma and advanced renal cell carcinoma.

Natco Pharma and Mylan have filed an ANDA containing a Paragraph IV certification for this product. The company manufactures this product at its facility in Kothur, Mahaboobnagar District in state of Telangana.

Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc., sells Sorafenib Tablets, 200mg, under Brand name NEXAVAR, in the US market. For the 12 months ending December 31, 2015, NEXAVAR had US sales of approximately $300 million.

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.