Lupin receives approval from U.S. FDA for Doxycycline Hyclate Delayed-Release Tablets USP

Global pharma major Lupin Limited (Lupin) has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Doxycycline Hyclate Delayed-Release Tablets USP, 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg, to market a generic equivalent of Doryx® Delayed-Release Tablets, 50 mg, 75 mg, 80 mg, 100 mg, 150 mg, and 200 mg and Doryx® MPC DelayedRelease Tablets, 60 mg and 120 mg, of Mayne Pharma International Pty. Ltd. This product will be manufactured at Lupin's Pithampur facility in India.

Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx ®) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT June 2023).

Shares of Lupin Limited was last trading in BSE at Rs. 1081.70 as compared to the previous close of Rs. 1076.95. The total number of shares traded during the day was 90529 in over 4824 trades.

The stock hit an intraday high of Rs. 1105.80 and intraday low of 1077.35. The net turnover during the day was Rs. 98894131.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 USFDA Approval ANDA DoxycyclineHyclate DelayedReleaseTablets