Natco Pharma gets USFDA approval for Tipiracil Hydrochloride and Trifluridine

16 Jun 2023 , 12:33 PM

Natco Pharma Limited announced that the US Food and Drug Administration (USFDA) has approved its Abbreviated New Drug Application (ANDA) for Tipiracil Hydrochloride and Trifluridine Tablets (generic for Lonsurf).

Taiho Oncology Inc. sells Lonsurf in the United States.

Natco believes it is one of the first-to-file for the product and may be eligible for a 180-day exclusivity period when it is released. Lonsurf is primarily indicated for the treatment of colorectal cancer.

According to IQVIA data, for the fiscal year ending December 2022, Lonsurf had annual sales of $211 million in the United States.

Natco Pharma Limited is a pharma company that is vertically integrated and focuses on R&D. It develops, manufactures, and markets finished dosage formulations (FDF) and active pharmaceutical ingredients (APIs). Our primary focus is on niche therapeutic areas and complex products.

At around 12.30 PM, Natco Pharma was trading 1.19% lower at Rs 631.95, against the previous close of Rs 639.55 on NSE. The counter touched an intraday high of Rs 654.90.

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