Zydus Life Sciences , a prominent player in the pharmaceutical industry, has achieved a significant milestone in its manufacturing capabilities. The company recently announced that its SEZ-II manufacturing facility in Ahmedabad has successfully passed a U.S. Food and Drug Administration (FDA) inspection with zero observations.

Inspection Details

The FDA conducted a Pre-Approval Inspection (PAI) at the Zydus SEZ-II manufacturing facility in Ahmedabad from August 11-14, 2025. The inspection concluded with the facility receiving a 'No Action Indicated' (NAI) classification, indicating that it meets all regulatory standards.

Key Highlights

• Inspection Period: August 11-14, 2025
• Inspection Type: Pre-Approval Inspection (PAI)
• Result: Zero observations
• Classification: No Action Indicated (NAI)
• Outcome: Establishment Inspection Report (EIR) received

The receipt of the Establishment Inspection Report (EIR) confirms the successful completion of the inspection process, marking a crucial achievement for Zydus Life Sciences in maintaining high-quality manufacturing standards.

Recent Developments

This approval comes on the heels of other positive developments for Zydus:

1. Budesonide Approval: On November 4, 2025, Zydus received tentative approval from the USFDA for Budesonide delayed-release capsules, 4 mg. This medication is indicated for mild to moderate active Crohn's disease.

2. Manufacturing Capabilities: The Budesonide capsules will be produced at the same SEZ-II facility in Ahmedabad that received the recent FDA approval.

3. ANDA Portfolio: As of September 30, 2025, Zydus has 425 approvals and has filed 487 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in FY 2003-04.

The successful FDA inspection and recent drug approval underscore Zydus Life Sciences' commitment to maintaining high-quality manufacturing processes and expanding its product portfolio in the U.S. market.

Zydus Life Sciences - Recent Milestones

These developments highlight Zydus Life Sciences' ongoing efforts to strengthen its position in the global pharmaceutical market through regulatory compliance and product innovation.

Zydus Lifesciences Limited , a prominent player in the pharmaceutical industry, has received a significant tax demand from Indian authorities. The company plans to challenge the order, maintaining its stance on the issue.

Demand Order Details

The Joint Commissioner of Common Adjudication Authority CGST, Ahmedabad, Gujarat, has issued a demand order to Zydus Lifesciences for ₹74.23 crores. This order pertains to an alleged excess refund claim of Integrated Goods and Services Tax (IGST) on the export of goods for the period from April 2018 to March 2024.

The Crux of the Matter

The tax authority claims that Zydus Lifesciences used the CIF (Cost, Insurance & Freight) value instead of the FOB (Free On Board) value for export calculations. This discrepancy forms the basis of the demand order.

Order Specifics

The order encompasses four GST registrations across Gujarat, Maharashtra, Himachal Pradesh, and Goa.

Company's Response

Zydus Lifesciences has stated its intention to challenge the order by filing an appeal. The company believes it has a strong case against the demand. In its disclosure to the stock exchanges, Zydus Lifesciences emphasized that there is no material financial impact on the company as a result of this order.

Implications

While the demand order represents a significant amount, Zydus Lifesciences' confident stance and immediate plan to appeal suggest that the company is prepared to defend its position. The outcome of this case could have implications for how pharmaceutical companies calculate IGST refunds on exports, potentially setting a precedent for the industry.

As the situation develops, stakeholders will be keenly watching how this case unfolds and its potential impact on Zydus Lifesciences' operations and the broader pharmaceutical sector's tax practices related to exports.