Lupin receives approval from U.S. FDA for Obeticholic Acid Tablets

Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Obeticholic Acid Tablets, 5 mg and 10 mg, a generic equivalent of Ocaliva® Tablets, 5 mg and 10 mg, of Intercept Pharmaceuticals, Inc. This product will be manufactured at Lupin's Nagpur facility in India.

Obeticholic Acid Tablets (RLD Ocaliva®) had estimated annual sales of USD 262 million in the U.S. (IQVIA MAT Mar 2023).

Shares of Lupin Limited was last trading in BSE at Rs. 803.65 as compared to the previous close of Rs. 805.45. The total number of shares traded during the day was 58805 in over 2225 trades.

The stock hit an intraday high of Rs. 813.30 and intraday low of 798.70. The net turnover during the day was Rs. 47313134.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 USFDA ANDAApproval ObeticholicAcidTablets