Natco Pharma has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Trabectedin for Injection (generic for Yondelis ) for the 1mg/vial presentation. According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.
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.