AstraZeneca Pharma gets nod to import for sale, distribution of Durvalumab Solution

31 Jan 2026 Evaluate

AstraZeneca Pharma India has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Durvalumab Solution for Infusion 120 mg/2.4 mL and 500 mg/10 mL [Brand Name: Imfinzi] for an additional indication.

Through this approval, Durvalumab in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single-agent Durvalumab, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).

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, if any.

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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