Lupin receives approval from U.S. FDA for Paliperidone Extended-Release Tablets

Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Paliperidone Extended-Release Tablets 1.5 mg, 3 mg, 6 mg, and 9 mg, to market a generic equivalent of Invega® Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg, of Janssen Research and Development, LLC. The product will be manufactured at Lupin's facility in Goa, India.

Paliperidone Extended-Release Tablets (RLD Invega®) had estimated annual sales of USD 152 million in the U.S. (IQVIA MAT March 2022).

Shares of Lupin Limited was last trading in BSE at Rs. 611.40 as compared to the previous close of Rs. 620.20. The total number of shares traded during the day was 29094 in over 1707 trades.

The stock hit an intraday high of Rs. 619.90 and intraday low of 607.40. The net turnover during the day was Rs. 17818065.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 USFDA ANDA Approval Paliperidone ExtendedReleaseTablets