AstraZeneca Pharma India gets CDSCO’s nod to import, distribute Durvalumab solutions

04 Mar 2025 Evaluate

AstraZeneca Pharma India has received approval from drug regulator - Central Drugs Standard Control Organisation (CDSCO) to import and distribute cancer treatment medicine Durvalumab solutions in the country. The approval by CDSCO, Directorate General of Health Services, Government of India is for import, for sale and distribution of Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) for an additional indication. 

Durvalumab in combination with Tremelimumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC). The receipt of this permission paves way for the marketing of Durvalumab solution for infusion 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) in India for the specified additional indication, subject to the receipt of related statutory approvals.

AstraZeneca Pharma India is a global biopharmaceutical company. The company is engaged in the discovery, development and commercialization of medicines for core areas of healthcare, including cardiovascular/metabolic disease, cancer and respiratory, inflammatory and autoimmune disease. The company operates through two segments Healthcare and Clinical Trial.

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