NSEGeneral Updates8 Aug 2026 · 8 Aug 2026, 11:38 am

General Updates

AstraZeneca Pharma India Limited · ASTRAZEN

✦ AI SummaryRegulatory

AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organization to import and sell Trastuzumab Deruxtecan 100mg/5mL lyophilized powder for concentrate for solution for infusion (Brand name: Enhertu) for an additional indication in India.

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Earnings Impact5/10
Growth Catalyst6/10
Governance Concern1/10
Regulatory Risk8/10
Balance Sheet Risk2/10
Liquidity Impact9/10
Market Sentiment5/10

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AstraZeneca Pharma India Limited has informed the Exchange about General Updates

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ASTRAZEN_08082026113742_Intimation_to_Stock_Exchanges_Enhertu_DB05.pdf

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August 8, 2026 The Manager- Listing BSE Limited P J Towers, Dalal Street, Fort, Mumbai - 400001 The Manager- Listing National Stock Exchange of India Limited Exchange Plaza Bandra –Kurla Complex, Bandra (E), Mumbai - 400051 Dear Sir, Sub: Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulation, 2015 This is to inform that on August 7, 2026, AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organization, Directorate General of Health Services, Government of India to import for sale and distribution of Trastuzumab Deruxtecan 100mg/5mL lyophilized powder for concentrate for solution for infusion (Brand name: Enhertu®) for an additional indication. Through this approval, Trastuzumab Deruxtecan Powder for Concentrate for Solution for Infusion 100 mg (ENHERTU) is indicated for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant Trastuzumab (with or without Pertuzumab) and taxane-based treatment. The receipt of this permission paves way for the marketing of Trastuzumab Deruxtecan 100mg/5mL lyophilized powder for concentrate for solution for infusion (Brand name: Enhertu®) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any. We request you to take the above intimation on record. Thanking you, For AstraZeneca Pharma India Limited Tanya Sanish Company Secretary & Compliance Officer