NATCO receives Tentative Approval for Olaparib Tablets from the U.S. FDA

NATCO Pharma Limited (BSE: 524816 and NSE: NATCOPHARM) ("NATCO") today received tentative approval from the U.S. FDA for Olaparib, 100 mg, and 150 mg, as bioequivalent to reference listed drug (RLD) Lynparza® tablets of AstraZeneca Pharmaceuticals for the indication in the approved labelling. NATCO will be manufacturing Olaparib tablets and our partner Alembic Pharmaceuticals Limited (Alembic), would be distributing the product in the U.S.

The Para IV litigation is on-going. Olaparib tablets had estimated sales of approximately USD 1.4 billion in the U.S. for 12 months ending Mar'26 as per industry sales data.

Shares of Natco Pharma Limited was last trading in BSE at Rs. 945.75 as compared to the previous close of Rs. 965.75. The total number of shares traded during the day was 91657 in over 2630 trades.

The stock hit an intraday high of Rs. 974.75 and intraday low of 941.65. The net turnover during the day was Rs. 86859159.00.

Source : Equity Bulls

Keywords

NatcoPharma INE987B01026 TentativeApproval USFDA Olaparib AstraZenecaPharmaceuticals