AstraZeneca Pharma India has received permission from the Central Drugs Standard Control Organization (CDSCO) to import and distribute Calquence tablets in India for an additional indication, according to a regulatory filing issued on May 21, 2026.
The approval covers Acalabrutinib maleate tablets 100 mg, sold under the brand name Calquence. The company said the permission was granted on May 20 by the Directorate General of Health Services under the CDSCO framework.
Under the approval, the drug can be used along with Bendamustine and Rituximab (BR) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).
Mantle cell lymphoma is a form of non-Hodgkin lymphoma that affects B lymphocytes, a type of white blood cell. Treatment plans for the condition generally depend on factors such as age, stage of disease, and transplant eligibility.
The company said the approval allows the import and marketing of the tablets in India for the specified indication, subject to related statutory approvals, if any.
The disclosure was submitted to the BSE Limited and the NSE Limited under Regulation 30 of SEBI’s listing norms. The filing was signed by Tanya Sanish, Company Secretary, and Compliance Officer.
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As of May 21, 2026, 2:40 pm, AstraZeneca Pharma India Ltd share price was trading at ₹8,602.50, down 0.081% from the previous closing price.
The latest regulatory clearance adds another approved use for Calquence in India in the treatment of mantle cell lymphoma patients covered under the specified category.
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Published on: May 21, 2026, 3:01 PM IST
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