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ASTRAZEN · price
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AstraZeneca Pharma India has received permission from CDSCO (Central Drugs Standard Control Organization) to import and distribute Acalabrutinib maleate tablets 100mg (Brand: Calquence®) for an additional indication. The drug is now approved for use in combination with Bendamustine and Rituximab (BR) to treat adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant. This approval expands the therapeutic scope of Calquence® in the Indian market, subject to any related statutory approvals that may be required. The permission was received on May 20, 2026, and the company submitted the intimation to stock exchanges on May 21, 2026.
This regulatory approval expands Calquence®'s addressable patient population in India, potentially boosting revenue for AstraZeneca Pharma India. Positive development for shareholders as it strengthens the company's oncology portfolio in the Indian market.