Zydus Lifesciences Limited has received a GST demand order of ₹2.8 crores from Gujarat tax authorities related to alleged tax credit violations during the financial year 2018-19. The pharmaceutical company disclosed this development under regulatory compliance requirements on December 30, 2025.

GST Demand Order Details

The Assistant Commissioner of State Tax, Gujarat, issued the demand order under section 74 of the CGST Act, 2017. The order addresses issues pertaining to inadmissible availment of Input Tax Credit for the financial year 2018-19.

Nature of Alleged Violation

The order specifically targets the company's Input Tax Credit availment practices during FY 2018-19. According to the tax authorities, certain Input Tax Credit claims were inadmissible under the provisions of the CGST Act, 2017. The total demand of ₹2.8 crores encompasses the principal amount along with applicable interest and penalty components.

Company's Response Strategy

Zydus Lifesciences has announced its intention to challenge the order through the appellate process. The company expressed confidence in its position, citing favorable precedents from higher judicial forums.

Key aspects of the company's stance:

• Plans to file an appeal against the demand order
• References past precedents from High Court and Supreme Court judgments
• Maintains optimism about securing a favorable outcome
• Asserts no material financial impact on operations

Financial and Operational Impact

The company has categorically stated that the GST demand order will not result in any material financial impact on its operations. This assessment appears to be based on the company's confidence in successfully appealing the order and the relatively modest size of the demand in relation to the company's overall financial position.

The disclosure was made in compliance with Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements Regulations, 2015, ensuring transparency with stakeholders regarding potential regulatory challenges.

Zydus Lifesciences has entered into a strategic partnership with Swiss biopharmaceutical company Bioeq AG for the commercialisation of NUFYMCO, an FDA-approved interchangeable biosimilar to Lucentis (Ranibizumab) in the US market. The collaboration marks a significant expansion of Zydus's US biosimilar business portfolio, with the US biosimilar Ranibizumab market worth $210.00 million.

Partnership Details and FDA Approval

The strategic partnership involves Zydus Lifesciences Global FZE, a wholly-owned subsidiary of Zydus based in the United Arab Emirates, collaborating with Bioeq for the licensing, supply and commercialisation of NUFYMCO. The Biologics License Application (BLA) for NUFYMCO received approval from the US Food and Drug Administration (USFDA) on December 18, 2025.

Role Distribution and Responsibilities

Under the terms of the agreement, both companies will leverage their respective strengths to ensure successful market penetration. Bioeq will be responsible for the development, manufacturing, registration and supply of the finished product, while Zydus will handle the commercialisation of NUFYMCO in the US market.

This partnership follows Zydus's recent collaboration with Formycon AG for a biosimilar of Keytruda (Pembrolizumab), demonstrating the company's strategic focus on expanding its US biosimilar business through partnerships with established European biopharmaceutical companies.

Market Opportunity and Strategic Vision

The total addressable market opportunity for biosimilar Ranibizumab in the US is approximately $210.00 million as per IQVIA MAT September 2025. Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, expressed enthusiasm about the collaboration, stating that the partnership will leverage combined expertise and resources to accelerate organisational growth while ensuring maximum value to patients through expanded access to affordable ophthalmology care.

Dr. Thiemo Schreiber, Vice President Commercial at Bioeq, highlighted the regulatory approval significance and emphasised how the partnership will leverage Zydus's extensive distribution network and strong sales and marketing capabilities across the US to broaden treatment options for patients.

Company Profiles

Zydus Lifesciences Limited operates as an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. As of September 30, 2025, the group employs 29,000 people worldwide, including 1,500 scientists engaged in R&D.

Bioeq AG, established in 2014, is a Swiss biopharmaceutical joint venture between Polpharma Biologics Group and Formycon AG. The company specialises in the development, licensing, and commercialisation of biosimilars for highly regulated markets worldwide, focusing on creating cost-effective alternatives to leading biologics.