Dr. Reddy's Laboratories has disclosed receiving five separate orders from the GST Authority imposing penalties totaling ₹8.38 crores for alleged tax violations spanning FY 2018-19 to FY 2022-23. The pharmaceutical company made this disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 on January 1, 2026.

GST Authority Orders Details

The Joint Commissioner, Office of Principal Commissioner of Central Tax, Visakhapatnam issued all five orders on December 31, 2025, which were received by the company on the same date. The orders seek demand including interest and levy penalties under the APGST Act 2017, alleging that Dr. Reddy's Laboratories availed excess input tax credit during the specified period.

Financial Year-wise Penalty Breakdown

The GST orders impose varying penalty amounts across the five financial years under scrutiny:

The highest penalty of ₹3.53 crores pertains to FY 2020-21, while the lowest penalty of ₹80.41 lakhs relates to FY 2019-20.

Company's Response and Impact Assessment

Dr. Reddy's Laboratories has stated that based on its evaluation, there is no material impact on the company's financials, operations, or other activities. The company indicated it will evaluate filing the necessary appeal with the appellate authority regarding these orders.

Regulatory Compliance

The disclosure was made in compliance with SEBI regulations, with the company providing detailed information about the nature of violations, receipt dates of orders, and financial implications. Company Secretary, Compliance Officer & Head-CSR K Randhir Singh signed the regulatory filing on behalf of Dr. Reddy's Laboratories Limited.

The orders represent the GST Authority's allegation that the company claimed excess input tax credit, though the company maintains its position that there will be no material adverse impact on its business operations.

Dr. Reddy's Laboratories has disclosed receiving a regulatory setback from the United States Food and Drug Administration regarding its biosimilar development program. The pharmaceutical company announced that its wholly owned subsidiary Dr. Reddy's Laboratories SA, Switzerland has received a Complete Response Letter for its AVT03 biosimilar application.

Regulatory Development Details

The Complete Response Letter pertains to the Biologics License Application for AVT03, which is a proposed biosimilar candidate to denosumab products Prolia and Xgeva. The CRL specifically refers to observations from a pre-license inspection of Alvotech's Reykjavik manufacturing facility. The biosimilar has been developed in partnership with Alvotech hf, an Iceland-based biopharmaceutical company specializing in biosimilar development.

Manufacturing Facility Inspection

The CRL specifically references observations arising from a pre-license inspection conducted at Alvotech's manufacturing facility located in Reykjavik. Pre-license inspections are routine regulatory procedures where the FDA evaluates manufacturing facilities to ensure compliance with current Good Manufacturing Practices before approving new drug applications.

About AVT03 Biosimilar

AVT03 represents Dr. Reddy's entry into the denosumab biosimilar market. Denosumab is a monoclonal antibody used for treating osteoporosis and preventing skeletal-related events in patients with bone metastases from solid tumors. The reference products Prolia and Xgeva are established treatments in the bone health therapeutic area.

Partnership Structure

The biosimilar development involves a collaboration between Dr. Reddy's Swiss subsidiary and Alvotech hf. This partnership structure allows Dr. Reddy's to leverage Alvotech's biosimilar development expertise while utilizing its own regulatory and commercial capabilities for market access.

Regulatory Disclosure

The announcement was made under Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements Regulations, 2015, ensuring transparency with stakeholders regarding material regulatory developments.