BSECompany Update2d ago · 28 Jul 2026, 01:21 pm

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AstraZeneca Pharma India Ltd · 506820

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AstraZeneca Pharma India Ltd has received permission from the Central Drugs Standard Control Organization to import and market 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 Impact2/10
Growth Catalyst6/10
Governance Concern1/10
Regulatory Risk1/10
Balance Sheet Risk1/10
Liquidity Impact8/10
Market Sentiment6/10

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AstraZeneca Pharma India Ltd - 506820 - Intimation Under Regulation 30 Of SEBI (Listing Obligations And Disclosure Requirements) Regulation, 2015

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July 28, 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/ Madam, Sub: Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulation, 2015 This is to inform that on July 27, 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 followed by a taxane, trastuzumab, and pertuzumab (THP) is indicated for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer. 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