Aurobindo Pharma informed the stock exchanges that the United States Food and Drug Administration (US FDA) has completed an inspection at one of its subsidiary’s manufacturing facilities in Telangana, concluding with four observations.
The inspection was carried out at Unit-I, a formulation manufacturing facility operated by Eugia Pharma Specialities Ltd., a wholly owned subsidiary of Aurobindo Pharma. The facility is located in Kolthur Village, Shameerpet Mandal, Ranga Reddy district, Telangana. The US FDA conducted the inspection from February 16 to February 27, 2026.
According to the company’s regulatory filing under Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015, the inspection concluded with four observations. These observations are typically issued in the Form 483 format when investigators identify conditions that may require corrective action.
Aurobindo Pharma stated that it will respond to the US FDA within the stipulated timelines and remains committed to maintaining the highest quality manufacturing standards across all its global facilities. The company also assured that it will keep the stock exchanges informed of any further developments related to the inspection.
US FDA inspections are a routine part of regulatory oversight for pharmaceutical manufacturers supplying products to the United States. The outcome and subsequent response from the company will be closely monitored by investors and market participants.