NSEPress Release4d ago · 18 Jul 2026, 04:39 pm
Press Release
Natco Pharma Limited · NATCOPHARM
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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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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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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