AstraZeneca Pharma gets CDSCO nod to market Imfinzi for muscle-invasive bladder cancer

AstraZeneca Pharma India Ltd, on Monday (July 14), said it has received permission from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, to import Durvalumab Solution for Infusion (brand name: Imfinzi) for an additional indication in the country.The approval allows the company to market Imfinzi 120 mg/2.4 ml and 500 mg/10 ml in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi monotherapy as adjuvant treatment post-radical cystectomy. This regimen is intended for adult patients with muscle-invasive bladder cancer (MIBC).

Also Read: AstraZeneca Pharma India shares rise 8% after revenue, margin jump in Q4
This regulatory clearance enables AstraZeneca to proceed with the marketing of the drug for the specified indication, subject to other statutory approvals, if applicable.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. 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 Q3 Results: Profit nearly doubles, margin expands sharply

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.

For the full year, AstraZeneca India also saw double-digit growth in revenue and operating profits, underscoring the resilience of its business despite macroeconomic headwinds and regulatory challenges.

Shares of Astrazeneca Pharma India Ltd ended at ₹9,171.40, down by ₹65.65, or 0.71%, on the BSE.

Also Read: Astrazeneca Pharma India Appoints Praveen Rao Akkinepally as MD