Natco gets USFDA approval for Tipiracil Hydrochloride, Trifluridine Tablets

Natco Pharma Ltd, on Friday, received final approval for its abbreviated new drug application (ANDA) for Tipiracil Hydrochloride and Trifluridine Tablets (generic for Lonsurf) from the US Food and Drug Administration (USFDA).

In a regulatory filing, the company said, “Natco believes it is one of the first-to-file for the product and may be eligible for a 180-day exclusivity at the time of launch.”

Lonsurf is sold in the US by Taiho Oncology Inc.

Lonsurf is indicated primarily for the treatment of colorectal cancer. As per IQVIA data, Lonsurf had generated annual sales of $211 million in USA during the twelve months ending December 2022, the company said in a statement.

Shares of Natco Pharma Ltd, on Friday, fell over 1 per cent at Rs 632 on BSE.

In April 2023, Natco Pharma said its board has approved setting up of a subsidiary in Indonesia with an investment of up to $3 million (nearly Rs 25 crore) for selling pharmaceutical products in that country.

The new subsidiary -- PT. NATCO Lotus Farma -- will be a joint venture with Natco holding 51 per cent and the balance stake 49 per cent by PT. Mitra Medis Exim (MME), a part of Mitra Jaya Group, which is a 40-year-old multi-diversified group, as the co-promoter, the company said in a regulatory filing.

Natco will initially invest $1 million for a stake of 51 per cent as capital contribution and balance will be invested as and when the funds are required by the subsidiary, it added.