NSEPress Release4d ago · 18 Jul 2026, 04:39 pm

Press Release

Natco Pharma Limited · NATCOPHARM

✦ AI Summary▲ PositiveOrder Win

Natco Pharma Limited has received tentative approval from the US FDA for its Olaparib tablets, a generic version of AstraZeneca's Lynparza, for the indication in the approved labelling.

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Earnings Impact8/10
Growth Catalyst9/10
Governance Concern1/10
Regulatory Risk2/10
Balance Sheet Risk1/10
Liquidity Impact8/10
Market Sentiment9/10

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Full Announcement

Natco Pharma Limited has informed the Exchange regarding a press release dated July 18, 2026, titled "NATCO received Tentative Approval for Olaparib Tablets from the United States Food and Drug Administration (U.S. FDA)".

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NATCOPHARM_18072026163843_PressRelease18072026.pdf

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July 18, 2026 Corporate Relationship Department Manager – Listing BSE Ltd. National Stock Exchange of India Ltd Mumbai 400 001 Mumbai 400 051 Scrip Code: 524816 Scrip Code: NATCOPHARM Dear Sir/Madam, Sub: Press Release under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 With reference to the above cited subject, please find enclosed herewith the Press Release under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 regarding the receipt of Tentative Approval for Olaparib Tablets from the United States Food and Drug Administration (U.S. FDA). This is for your information. Thanking you, Yours faithfully For NATCO Pharma Limited Ch. Venkat Ramesh Company Secretary & Compliance Officer Encl: As above Natco Pharma Limited Regd. Off. Press Release NATCO Pharma Ltd NATCO House Road No.2, Banjara Hills Hyderabad-500 034, India NATCO receives Tentative Approval for Olaparib Tablets from the United States Food and Drug Administration (U.S. FDA) Hyderabad, India, July 18th, 2026: 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. *Safe Harbor Statement All brand names and trademarks are the property of their respective owners About NATCO Pharma Limited NATCO Pharma Limited, (NSE:NATCOPHARM, BSE: 524816, Reuters: NATP.NS, Bloomberg: NTCPH,) headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The Company is a R&D oriented, and a science driven leading Oncology player in the targeted therapies of domestic market and focuses on limited competition molecule in the US. The Company has 9 manufacturing sites and 2 R&D facilities in India. The Company’s different manufacturing facilities are approved by several leading regulatory authorities like U.S. FDA, Brazil ANVISA, Health Canada, WHO and others catering to 50+ global markets. For more information, please visit us at www.natcopharma.com. For further information or queries please contact: Rajeev Menon – Investor Relations Email: r.menon@natcopharma.co.in Tel: 040-23547532 / Ext – 323 Follow us on: X (formerly Twitter): https://x.com/pharma_natco LinkedIn: https://www.linkedin.com/company/natcopharma