US FDA Issues Warning Letter to Aurobindo Pharma Facility Near Hyderabad

A formulation manufacturing facility belonging to Eugia Pharma Specialities, a subsidiary of Aurobindo Pharma located near Hyderabad, has received a warning letter from the United States Food and Drug Administration (U.S. FDA).

The regulatory action comes after an inspection in February, during which the U.S. FDA issued four observations. In May, the regulator classified the plant under Official Action Indicated (OAI) status, which indicates that regulatory or administrative actions are recommended. Following this classification, the U.S. FDA issued the formal warning letter to the unit.

Aurobindo Pharma disclosed the development in a regulatory filing, stating that it does not anticipate any disruption or impact on its existing supplies to the U.S. market. The affected facility, Unit I of Eugia Pharma Specialities, contributes approximately 2% to the company's overall group revenue.

Following the announcement, Aurobindo Pharma's shares on the BSE traded around 1.25% lower at ₹1,636.20 around noon, recovering slightly after a sharper drop when markets opened.

Financially, the parent company reported revenue from operations of ₹9,150 crore for the quarter ended June. For the full financial year, it registered revenue from operations of ₹33,653 crore.

Aurobindo Pharma stated that it remains committed to working closely with the U.S. FDA and continues to enhance compliance across its facilities on an ongoing basis.

Under U.S. FDA procedures, inspection outcomes are classified into three categories: No Action Indicated (NAI), where no objectionable conditions are found; Voluntary Action Indicated (VAI), where objectionable conditions were noted but do not warrant administrative action; and Official Action Indicated (OAI), which leads to further regulatory actions.