Aurobindo Pharma Limited has informed the stock exchanges that the US Food and Drug Administration completed a regulatory inspection at Auroactive Pharma Private Limited, a wholly owned subsidiary of Aurobindo Pharma. The US FDA conducted the inspection across five days from June 22 to June 26, 2026, at the subsidiary's facility.
The Auroactive Pharma facility is located at Sy Nos 231, 285 to 291, Sancham Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh. The site is engaged in the manufacture of Active Pharmaceutical Ingredients (API) and Pharmaceutical Formulation Intermediates. Aurobindo Pharma made the announcement to the exchanges on June 27, 2026.
The regulatory inspection concluded with 2 observations. Aurobindo Pharma will submit its response to the observations within the stipulated time.
Aurobindo Pharma has confirmed that there is no impact on its financials or operations from this inspection.
Aurobindo Pharma received the communication from the US FDA on June 26, 2026. The disclosure was made to the National Stock Exchange of India and BSE Limited under Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements Regulations, 2015. A detailed annexure containing information on the authority, nature of action, date of receipt, observations, and impact was submitted as part of the filing.
Aurobindo Pharma will keep the stock exchanges informed of any further developments regarding this matter.
Disclaimer: This article is based on company filings submitted to the Bombay Stock Exchange (BSE) and National Stock Exchange of India (NSE) and is for informational purposes only. It does not constitute investment advice or a recommendation. Investors should conduct their own research and consult a qualified financial advisor before making investment decisions.