Natco Pharma files ANDA for Tipiracil Hydrochloride Tablets

03 Jan 2020 Evaluate

Natco Pharma has submitted an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the US Food and Drug Administration (USFDA) for the generic version of Lonsurf (Trifluridine/ Tipiracil) tablets (15mg/6.14mg and 20mg/8.19mg).

Lonsurf has recorded sales of $150 million for the year ending December 2018 in the US market as per IQVIA. The drug is currently indicated for certain forms of Colorectal and Gastric Cancers. Lonsurf is a registered trademark of Taiho Oncology, INC.

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.

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