Natco Pharma Ltd announces submission of Abbreviated New Drug Application

Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has announced its submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of TABRECTA® (Capmatinib hydrochloride) Eq 150mg base and Eq 200 mg base tablets. TABRECTA® is the brand of Novartis. Natco believes it is the first company to have filed a substantially-complete ANDA containing a paragraph IV certification for this product and expects to be eligible for 180 days of sole marketing exclusivity at the time of potential launch of the product under certain circumstances.

TABRECTA® has recorded sales of USD 126 million in the US market for the year 2023.

Capmatinib hydrochloride is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a specific type of mutation.

Shares of Natco Pharma Limited was last trading in BSE at Rs. 1499.55 as compared to the previous close of Rs. 1540.50. The total number of shares traded during the day was 88591 in over 8043 trades.

The stock hit an intraday high of Rs. 1549.80 and intraday low of 1490.00. The net turnover during the day was Rs. 133577533.00.

Source : Equity Bulls

Keywords

NatcoPharma INE987B01026 ANDA USFDA Para4Certification GenericVersion TABRECTA