AstraZeneca Pharma gets drug body OK to import, sell trastuzumab deruxtecan
This story was originally published at 21:09 IST on 3 October 2025
Register to read our real-time news.Informist, Friday, Oct. 3, 2025
MUMBAI – AstraZeneca Pharma India Ltd. said Friday it has been permitted by the Central Drugs Standard Control Organisation of the Directorate General of Health Services, government of India, to import the antibody-drug conjugate trastuzumab deruxtecan for sale and distribution in the country. The company said in an exchange filing that the permission applies to trastuzumab deruxtecan 100 milligram per 5 millilitre vial lyophilised powder for concentrate for solution for infusion.
The product, marketed under the brand name Enhertu, is used to treat adult patients with unresectable or metastatic human epidermal growth factor receptor2-positive tumours, particularly breast and stomach cancers, who have received prior systemic treatment and have no satisfactory alternative treatment options.
The receipt of permission paves the way for the company to market the product in India for the specified additional indication, subject to the receipt of related statutory approvals, if any, the company added in the filing.
AstraZeneca Pharma India had reported a net profit of INR 558.3 million for the June quarter on a revenue of INR 5.26 billion. Friday, shares of the company closed 1.3% higher at INR 9,339 on the National Stock Exchange. End
Reported by Pooja Sawant
Edited by Rajeev Pai
For users of real-time market data terminals, Informist news is available exclusively on the NSE Cogencis WorkStation.
Cogencis news is now Informist news. This follows the acquisition of Cogencis Information Services Ltd. by NSE Data & Analytics Ltd., a 100% subsidiary of the National Stock Exchange of India Ltd. As a part of the transaction, the news department of Cogencis has been sold to Informist Media Pvt. Ltd.
Informist Media Tel +91 (22) 6985-4000
Send comments to feedback@informistmedia.com
© Informist Media Pvt. Ltd. 2025. All rights reserved.
To read more please subscribe
Share this Story:
