AstraZeneca gets CDSCO nod for new indications of Benralizumab, Osimertinib in India
Bangalore: AstraZeneca Pharma India Limited has received regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services, Government of India, to import for sale and distribution of Benralizumab 30 mg/ml Solution for Injection (Brand name: Fasenra) and Osimertinib Tablets 40 mg & 80 mg (TAGRISSO) for an additional indication in India.
The company stated that this regulatory nod paves the way for the marketing of Benralizumab and Osimertinib in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.
Earlier, in April 2025, the Medical Dialogues team reported that AstraZeneca had received CDSCO permission to import for sale and distribute Osimertinib Tablets 40 mg and 80 mg (Tagrisso) for another additional indication. That approval 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 NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
Read also: AstraZeneca Pharma India gets CDSCO nod to import, distribute lung cancer drug Osimertinib
AstraZeneca India was established in 1979 and is headquartered at Bengaluru, Karnataka. AstraZeneca Pharma India Limited is the operating company and covers manufacturing, sales and marketing activities of the company in India.
It is a listed company and is a subsidiary of AstraZeneca Plc, UK.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.