Zydus Lifesciences has achieved a significant regulatory milestone by receiving tentative approval from the US Food and Drug Administration (USFDA) for Dapagliflozin tablets. The approval covers both 5 mg and 10 mg strengths of the medication, which is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.

Market Opportunity and Commercial Potential

The USFDA approval positions Zydus Lifesciences to enter a substantial market segment, as Dapagliflozin tablets represent a significant commercial opportunity in the US pharmaceutical market. The drug had annual sales of USD 10,486.90 million in the United States according to IQVIA MAT December 2025 data.

Regulatory Significance and Portfolio Impact

The tentative approval from the USFDA represents an important step in Zydus Lifesciences' regulatory pathway for this diabetes medication. Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that provides healthcare providers with an effective treatment option for Type 2 diabetes management.

Manufacturing and ANDA Portfolio

The Dapagliflozin tablets will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad. This approval adds to Zydus Lifesciences' robust regulatory portfolio, bringing the group's total approvals to 430. The company has filed 505 ANDAs since commencing the filing process in FY 2003-04, demonstrating its sustained commitment to expanding its generic pharmaceutical offerings.

Strategic Market Position

This approval strengthens Zydus Lifesciences' presence in the diabetes care segment, adding to its existing portfolio of therapeutic solutions. The substantial annual US sales figure underscores the significant market potential and commercial value of this regulatory achievement for the company's US operations.

Zydus Lifesciences Ltd on Friday announced the completion of a US Food and Drug Administration (USFDA) inspection at its Unit-2 manufacturing facility in Ankleshwar, Gujarat. The regulatory review, conducted from 19 to 23 January, 2026, concluded with three observations, with the company noting that none were related to data integrity concerns.

USFDA Inspection Results

The pharmaceutical company stated it will collaborate closely with the USFDA to address the identified observations promptly. The completion of the inspection represents a routine regulatory milestone for the manufacturing facility.

Launch of Cancer Biosimilar

In a separate announcement, Zydus introduced Tishtha™, positioned as the world's first biosimilar of Nivolumab, a cancer immunotherapy drug. The treatment addresses multiple cancer types and will be available in the Indian market at approximately one-fourth the cost of the reference drug.

The biosimilar will be offered in two dosage options to optimize treatment protocols:

This pricing strategy aims to enable oncologists to optimize dosing while minimizing drug wastage, potentially improving access to advanced oncology treatments across India.

Acquisition Speculation

Regarding media reports about potential acquisition discussions with US biopharmaceutical company Ardelyx, Zydus declined to provide commentary on business development activities. Sources had indicated on 20 January that the company might pursue either a controlling stake acquisition or selective molecule purchases as part of a proposed transaction.

Market Performance

Shares of Zydus Lifesciences Ltd closed trading on Friday, January 23, at ₹883.00 on the NSE, representing a decline of 0.26% for the session.