AstraZeneca Pharma India Secures CDSCO Approval for New Cancer Treatment

AstraZeneca Pharma India Ltd has received crucial approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute its cancer treatment medication, Durvalumab. This announcement was made on March 3, 2025, paving the way for the marketing of this critical therapy in the Indian market.

The CDSCO has granted permission for the infusion solutions of Durvalumab, available in 120 mg/2.4 ml and 500 mg/10 ml formulations, known commercially as Imfinzi. This approval allows AstraZeneca to promote Durvalumab in combination with Tremelimumab for treating patients with unresectable hepatocellular carcinoma (uHCC).

This regulatory clearance is a significant milestone for AstraZeneca as it expands its oncology portfolio in India, addressing the needs of patients suffering from this aggressive form of liver cancer. The company is now set to proceed with marketing these solutions, contingent upon obtaining all necessary statutory approvals.

As the demand for effective cancer treatments continues to rise, AstraZeneca’s expansion of its offerings in India underscores its commitment to improving healthcare outcomes for patients battling cancer.