Aurobindo Pharma Limited has announced the completion of a United States Food and Drug Administration (USFDA) inspection at its Raleigh, North Carolina facility, operated by Aurolife Pharma LLC, a wholly owned step-down subsidiary of the company.
The inspection, which took place from March 24 to April 10, 2025, focused on the facility established for manufacturing inhalers and dermatology products. At the conclusion of the inspection, the USFDA issued a Form 483 with 11 observations. According to the company, these observations are procedural in nature.
Aurobindo Pharma stated that it will provide a detailed response to the USFDA within the required timeframe. The response will include corrective and preventive actions (CAPA) to address each observation.
The company further clarified that it does not anticipate any material impact on its current business operations or ongoing product supplies from the facility as a result of this development.
Aurobindo Pharma has committed to keeping the stock exchanges informed of any further updates related to this matter.
In the meantime, Aurobindo Pharma shares opened today at ₹1,099.50 today, reaching a high of ₹1,109.80 and dipping to a low of ₹1,073.10. The stock remains volatile, trading significantly below its 52-week high of ₹1,592.00 but above the 52-week low of ₹1,010.00
