Hyderabad: Natco Pharma Limited 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.
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Natco Pharma Limited was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 employees, Natco today has eight manufacturing facilities spread across India with modern research laboratories, capabilities in New Drug Development, etc.
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