NATCO Pharma Receives Tentative U.S. FDA Approval for Olaparib Tablets

NATCO Pharma Receives Tentative U.S. FDA Approval for Olaparib Tablets​

Natco Pharma Limited has secured tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Olaparib tablets, signaling a significant development in the targeted oncology market.

The approval covers Olaparib 100 mg and 150 mg, confirming the drug is bioequivalent to Lynparza® tablets, which are manufactured by AstraZeneca Pharmaceuticals. This indication corresponds with the approved labelling specifications.

NATCO Pharma Limited will be responsible for manufacturing the Olaparib tablets. The company has partnered with Alembic Pharmaceuticals Limited, who will handle the distribution of the product in the U.S. market.

The success of this venture is against a backdrop where Para IV litigation is ongoing. Industry sales data indicated that Olaparib tablets held an estimated sales potential of approximately USD 1.4 billion in the U.S. for the 12 months ending March 2026.

NATCOPHARM Stock Price Movement​

Natco Pharma Limited shares slipped on Friday, closing at ₹945.00 after shedding 2.40% or ₹23.20 from the previous close. The stock saw considerable trading volume of 338,307 shares, settling within an intraday range defined by a low of ₹940.10 and a high of ₹968.50.