Pharma major Lupin and Natco announced the final ANDA approval of Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) from the United States Food and Drug Administration (FDA). The product, as the first generic, will be launched shortly.

Natco’s Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) are generic equivalents of Shire Development LLC's Fosrenol Chewable Tablets 500 mg, 750 mg and 1000 mg. Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) are indicated to reduce serum phosphate in patients with end stage renal disease (ESRD).

Fosrenol Chewable Tablets has US sales of USD 122.4 million (IMS MAT June 2017). Lupin and Natco had entered into an agreement on September 01, 2008 to jointly commercialize generic equivalents of Fosrenol Chewable Tablets.

Nilesh Gupta, Managing Director, Lupin said, ''We are very happy to finally be able to launch Lanthanum Carbonate Chewable Tablets in partnership with Natco. Lupin’s proven IP capabilities, marketing reach and expertise coupled with Natco’s solid development and manufacturing abilities make a great combination''.

Shares of the company gained Rs 25.35, or 2.69%, to settle at  Rs 967.60.  The total volume of shares traded  was  149,420 at the BSE (Monday).