BSECompany Update8 Aug 2026 · 8 Aug 2026, 11:34 am
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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 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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AstraZeneca Pharma India Ltd - 506820 - Intimation Under Regulation 30 Of SEBI (Listing Obligations And Disclosure Requirements) Regulation, 2015
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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