AstraZeneca Pharma India Limited has submitted a regulatory disclosure under SEBI Listing Regulations Regulation 30 regarding receipt of drug approval permission.
On July 15, 2026, the company received permission from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India for import, sale and distribution of Benralizumab 30 mg/ml solution for injection in pre-filled syringe under the brand name Fasenra® for an additional indication.
The approval specifically covers the treatment of patients aged 12 years and older with Hypereosinophilic Syndrome (HES) without an identifiable non-haematologic secondary cause.
This permission enables the marketing of Benralizumab 30 mg/ml solution for injection in pre-filled syringe (Fasenra®) in India for the specified additional indication, subject to receipt of related statutory approvals that may be required.
The disclosure was signed by Tanya Sanish, Company Secretary & Compliance Officer of AstraZeneca Pharma India Limited, and submitted to both BSE Limited and National Stock Exchange of India Limited on July 16, 2026.