AstraZeneca Pharma gets permission to Import for sale and distribution of Trastuzumab deruxtecan solution

04 May 2023 Evaluate

AstraZeneca Pharma India has received a permission in Form CT-20 to Import for sale and distribution of Trastuzumab deruxtecan (Enhertu) 100mg/5mL vial lyophilized powder for concentrate for solution for infusion from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India. Through this approval, Trastuzumab deruxtecan (Enhertu) is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen.

The receipt of this permission paves way for the launch of Trastuzumab deruxtecan (Enhertu) solution of 100mg/5mL in India for the specified 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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