AUROBINDO SHARES SLIP AFTER US FDA ISSUES THREE OBSERVATIONS

Aurobindo Pharma’s share price edged lower in early trade on August 31 after the company disclosed that the US Food and Drug Administration (US FDA) issued three observations following an inspection of one of its API manufacturing facilities. The US FDA conducted an inspection of Unit-VI, an API manufacturing facility operated by Apitoria Pharma, a wholly owned subsidiary of Aurobindo Pharma, in Anakapalli district, Andhra Pradesh. The inspection was carried out from August 24 to August 28, 2026, and concluded with three observations. According to the company, the observations are procedural in nature, and it will submit its response to the US FDA within the stipulated timeline. The development follows a similar inspection last week at Lannett Company LLC, a wholly owned step-down subsidiary of Aurobindo Pharma, located in Seymour, Indiana, USA. The inspection, conducted from August 17 to August 21, resulted in four observations, which the company also described as procedural in nature. Separately, AuroPeptides, the company’s Telangana-based subsidiary engaged in manufacturing peptide APIs, received one observation from the US FDA related to facility and equipment maintenance. Despite the regulatory developments, Aurobindo Pharma’s stock remains well above its yearly low. The shares touched a 52-week high of ₹1,682 on August 13, 2026, and a 52-week low of ₹1,017 on September 2, 2025. The company’s market capitalisation stands at approximately ₹95,701.59 crore.