The company stated that the approval paves the way for marketing of Enhertu in India for the specified additional indication, subject to receipt of other related statutory approvals, if any. Shares of Astrazeneca Pharma India Ltd ended at ₹9,320.00, up by ₹98.75, or 1.07%, on the BSE.

AstraZeneca Pharma India | The drug firm has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import, sell, and distribute durvalumab (Imfinzi) solution for infusion in 120 mg/2.4 ml and 500 mg/10 ml doses for an additional indication. With this approval, durvalumab can now be used for treating patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT).

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Published Oct 03, 2025 | 12:22 PM GMT-04

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Drug firm AstraZeneca Pharma India Limited on Friday (October 3) said it has received approval from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, to import, sell, and distribute trastuzumab deruxtecan 100mg/5mL vial lyophilised powder for concentrate for solution for infusion (brand name: Enhertu) for an additional indication.

Under this approval, Enhertu is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours, who have received prior systemic treatment and have no satisfactory alternative treatment options.

The company stated that the approval paves the way for marketing of Enhertu in India for the specified additional indication, subject to receipt of other related statutory approvals, if any.

Also Read: AstraZeneca vows to spend $50 billion on US manufacturing, development

Fourth Quarter Results

AstraZeneca Pharma India posted a sharp 47.7% year-on-year jump in net profit to ₹58.2 crore for the fourth quarter ended March 2025, up from ₹39.4 crore a year earlier. The robust performance was underpinned by solid growth in revenue and a significant expansion in operating margin.

Revenue for the quarter rose 25.4% to ₹480.4 crore, compared with ₹383.2 crore in the same period last year, driven by continued demand across its key therapy areas and improved market penetration.

Earnings before interest, tax, depreciation and amortisation (EBITDA) surged 74.7% to ₹86.3 crore from ₹49.4 crore a year ago, reflecting better cost controls and favourable product mix. The company’s EBITDA margin expanded to 17.96%, up from 12.89% in the corresponding quarter last year.

Also Read: AstraZeneca Pharma India shares rise 8% after revenue, margin jump in Q4

Shares of Astrazeneca Pharma India Ltd ended at ₹9,320.00, up by ₹98.75, or 1.07%, on the BSE.