AstraZeneca Pharma India Limited on Tuesday (July 1) said it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import durvalumab solution for infusion (Brand name: Imfinzi) in 120 mg/2.4 ml and 500 mg/10 ml strengths for an additional indication.
The new indication allows durvalumab, in combination with carboplatin and paclitaxel, to be used as a first-line treatment for adults with primary, advanced, or recurrent endometrial cancer who are candidates for systemic therapy.
This is to be followed by maintenance treatment with durvalumab and olaparib for endometrial cancer that is mismatch repair proficient (pMMR).
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This regulatory clearance enables AstraZeneca to market the approved formulation of Imfinzi in India for the specified indication, subject to other applicable statutory approvals.
Fourth quarter boost
AstraZeneca Pharma India posted a sharp 47.7% year-on-year (YoY) jump in net profit to ₹58.2 crore for the fourth quarter ended March 2025, up from ₹39.4 crore a year earlier.
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 a favourable product mix. The company’s EBITDA margin expanded to 17.96%, up from 12.89% in the corresponding quarter last year.
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The management attributed the strong financial results to continued investment in innovation and its portfolio of newer-generation therapies in the oncology, cardiovascular, and respiratory segments.
Shares of AstraZeneca Pharma India Ltd ended at ₹8,890, up by ₹18.30, or 0.21%, on the BSE.
