AstraZeneca Pharma gets nod to import Osimertinib Tablets 40 mg & 80 mg

05 Apr 2025 Evaluate

AstraZeneca Pharma India has received permission from the Central Drugs Standard Control Organization, Directorate General of Health Services, Government of India to import for sale and distribution of Osimertinib Tablets 40 mg & 80 mg (TAGRISSO) for an additional indication.

Through this approval, Osimertinib is indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

The receipt of this permission paves way for the marketing of Osimertinib Tablets 40 mg & 80 mg (TAGRISSO) 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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