AstraZeneca Pharma India wins CDSCO permission to import breast cancer drug Datverzo

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-12-18 09:45 GMT | Update On 2025-12-18 09:45 GMT

Bangalore: AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India to import for sale and distribution of Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin), under Brand name Datverzo, which is a new drug in India.

Through this approval, Datverzo is indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

The receipt of this permission paves way for the marketing of Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin) (Brand name: Datverzo) in India for the specified indication, subject to the receipt of related statutory approvals, if any.

Read also: AstraZeneca Gets SEC Nod for New Trastuzumab Deruxtecan Indication in HER2-Positive Solid Tumors

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.

Read also: AstraZeneca Pharma India gains CDSCO permission for Enhertu in HER2-positive solid tumours

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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AstraZeneca Pharma India wins CDSCO permission to import breast cancer drug Datverzo

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