USFDA Inspects Zydus Lifesciences' Biologics Injectable Plant in Ahmedabad; Reports 7 Observations

Zydus Lifesciences Limited has informed stock exchanges that the United States Food and Drug Administration (USFDA) has concluded a GMP (Good Manufacturing Practice) surveillance inspection at its Biologics Injectable manufacturing facility. The disclosure was made pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Inspection Details

The USFDA conducted the GMP surveillance inspection at the company's Unit 9 facility, situated at Zydus Biotech Park, Changodar, Ahmedabad. The key details of the inspection are summarised below:

Parameter:	Details
Facility:	Unit 9, Zydus Biotech Park, Changodar, Ahmedabad
Facility Type:	Biologics Injectable Plant
Inspection Type:	GMP Surveillance Inspection
Inspection Period:	April 27 to May 5, 2026
Total Observations:	Seven
Data Integrity Observations:	None

Outcome and Next Steps

The inspection closed with seven observations. Notably, there were no data integrity related observations recorded during the inspection. Zydus Lifesciences stated that the company will closely work with the USFDA to address the observations expeditiously.

The development was communicated to BSE Limited and the National Stock Exchange of India Limited as a regulatory disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

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Zydus Lifesciences Limited has disclosed, under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, that its wholly owned subsidiary, Zydus VTEC Limited (ZVTEC), has received a demand Order-In-Original from the Deputy Commissioner of CGST & Central Excise, Ahmedabad North Commissionerate. The order was received at 11:21 a.m. on May 4, 2026, and the disclosure was filed on May 5, 2026.

Nature of the Demand Order

The order has been passed under Section 74 of the CGST Act, 2017, and pertains to the period from September 2020 to March 2023. The authority has raised a demand and imposed a penalty of Rs. 9.00 million each on ZVTEC, citing alleged availment of inadmissible Input Tax Credit during the said period. The key details of the order as disclosed are summarised below:

Parameter:	Details
Authority:	Deputy Commissioner of CGST & Central Excise, Ahmedabad North Commissionerate
Nature of Order:	Demand and penalty under Section 74 of CGST Act, 2017
Demand Amount:	Rs. 9.00 million
Penalty Amount:	Rs. 9.00 million
Period Covered:	September 2020 to March 2023
Date of Receipt:	11:21 a.m. on May 4, 2026
Alleged Violation:	Inadmissible Input Tax Credit availment

Company's Response and Financial Impact

Zydus Lifesciences has stated that ZVTEC firmly believes the matter has strong merits and intends to appeal against the order. The company has cited past precedents of High Court and Supreme Court judgments on the matter, expressing confidence in obtaining a favourable outcome on appeal.

With respect to the financial implications, the company has clarified that there is no material financial impact on either ZVTEC or on Zydus Lifesciences Limited as a result of this order.

Regulatory Disclosure

The disclosure was made in compliance with Regulation 30 read with Schedule III of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, and the SEBI Master Circular dated January 30, 2026. The filing was signed by Dhaval N. Soni, Company Secretary and Compliance Officer of Zydus Lifesciences Limited (Membership No. FCS7063).