Hot Pursuit     16-Jun-23
Natco Pharma gets USFDA nod for colorectal cancer drug
Natco Pharma said that it has received final approval from US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA), Tipiracil Hydrochloride and Trifluridine Tablets.
The said drug is generic equivalent to Lonsurf of Taiho Oncology Inc. It 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.

Meanwhile, the company has received an Establishment Inspection Report (EIR) from USFDA for its drug formulations manufacturing facility at Visakhapatnam (Vizag), Andhra Pradesh, India. The US drug regulator conducted an inspection during the period from 30 January to 3 February 2023.

Natco Pharma is engaged in the business of pharmaceuticals which comprises research and development, manufacturing and selling of bulk drugs and finished dosage formulations. The company has manufacturing facilities in India which caters to both domestic and international markets including regulated markets like United States of America and Europe.

The company reported consolidated net profit of Rs 275.80 crore in Q4 FY23 as compared with net loss of Rs 50.50 crore in Q4 FY22. Net sales jumped 50.5% year on year to Rs 897.90 crore in Q4 FY23.

The scrip was down 0.16% to Rs 638.60 on the BSE.

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