AstraZeneca Pharma gets CDSCO nod to import and distribute TAGRISSO (Osimertinib)

AstraZeneca Pharma India announced that it has received approval from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India, to import and distribute Osimertinib Tablets (TAGRISSO).

The newly approved indication allows Osimertinib to be used in combination with pemetrexed and platinum-based chemotherapy as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

The company said that this approval paves the way for the marketing of Osimertinib Tablets 40 mg and 80 mg (TAGRISSO) in India for the specified additional indication, subject to the receipt of any related statutory approvals.

AstraZeneca Pharma India is engaged in the business of manufacture, distribution, and marketing of pharmaceutical products and also provides clinical trial services to an overseas group company.

The company?s standalone net profit surged to Rs 54.68 crore in Q3 FY25 as compared with Rs 15.80 crore in Q3 FY24. Revenue from operations jumped 44% to Rs 440.29 crore in Q3 FY25 as compared with Rs 305.79 crore in Q3 FY24.

The scrip fell 2.27% to end at Rs 7,908.50 on Friday, 4 April 2025.

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