Aurobindo Pharma Received Form 483 With 9 Observations From US FDA For Jedcherla Unit

Aurobindo Pharma Limited has informed exchanges that the United States Food and Drug Administration (US FDA) issued a 'Form 483' with 9 observations following an inspection of its  oral solid dosage manufacturing unit in Telangana. The regulator conducted the audit of the company’s Unit-VII facility from January 28, 2026, to February 10, 2026.

The company in the release stated that "all observations are procedural in nature" and confirmed that it intends to respond to the US regulator within the stipulated timelines. The disclosure was made pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Regarding the potential effect on business, the filing explicitly noted: "There is no impact on the company’s financials or operations due to the said action." The company reiterated its commitment to maintaining the "highest quality manufacturing standards" across its global facilities.