Aurobindo Pharma has received a Form 483 from the US Food and Drug Administration containing 9 observations related to its Eugia Pharma Unit-II facility. The regulatory communication represents a formal notice of deficiencies identified during an FDA inspection of the manufacturing facility from November 03 to November 14, 2025.

FDA Inspection Details

The US FDA inspected Unit-II of Eugia Pharma Specialities Limited, a wholly owned subsidiary of Aurobindo Pharma, situated at RIICO Industrial Area, Phase-III, Bhiwadi, Rajasthan. Following the inspection completion, the FDA issued Form 483 with 9 observations and subsequently classified the facility as 'Official Action Indicated'.

Company Response and Business Impact

Aurobindo Pharma has informed stock exchanges about the FDA classification under SEBI Regulation 30. The company stated that it does not foresee any impact on business operations at this point in time. The pharmaceutical manufacturer emphasized its commitment to maintaining the highest quality manufacturing standards across all global facilities.

Regulatory Implications

Form 483 represents the FDA's official documentation of conditions or practices that may violate food, drug, or cosmetic regulations. The 'Official Action Indicated' designation suggests that the observations require formal response and corrective action from the pharmaceutical manufacturer to maintain compliance with FDA standards.

Aurobindo Pharma Limited has disclosed that the Principal Commissioner of Customs and Central Tax (Appeals I), Hyderabad, has confirmed a GST demand of Rs. 77,61,35,242/- along with an equal penalty amount. The pharmaceutical company received the appellate order on March 12, 2026, and informed stock exchanges on March 13, 2026, in compliance with SEBI regulations.

GST Demand Details

The confirmed demand stems from three primary allegations against the company during the period from July 1, 2017, to March 23, 2020. The tax authorities have alleged that Aurobindo Pharma availed excess IGST refunds based on CIF versus FOB valuations, failed to surrender IGST refunds on account of short realization of export proceeds under Rule 96 of CGST Rules, and did not reverse Input Tax Credit as required under Rule 37 of CGST Rules.

Appellate Authority Decision

The Principal Commissioner of Customs and Central Tax (Appeals I), Hyderabad, partially allowed the company's appeal by dropping the demand for interest on ITC reversed under Rule 37 of CGST Rules. However, the appellate authority upheld the original demand and penalty that were confirmed by the Additional Commissioner of Central Tax, Ranga Reddy GST Commissionerate, Hyderabad, in its order dated January 28, 2025.

The company had previously received the original authority's order on February 4, 2025, and had duly informed the stock exchanges on February 5, 2025, maintaining transparency in its regulatory disclosures.

Company's Response and Financial Impact

Aurobindo Pharma has stated that there is no material impact on the company's financials or operations due to the confirmed order. The pharmaceutical manufacturer has already taken proactive measures by paying Rs. 23,71,71,782/- under protest and reversing ITC of Rs. 8,78,23,385/-, which has been accepted by the tax authorities.

Future Legal Action

The company has indicated its intention to file an appeal against the appellate order dated February 27, 2026, before the Goods and Services Tax Appellate Tribunal (GSTAT) within the stipulated timeframe. This represents the next level of judicial review available to challenge the confirmed GST demand and penalty.

The disclosure was made pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, ensuring compliance with stock exchange notification requirements for material developments affecting listed entities.