Aurobindo Pharma's US Plant Gets 11 FDA Observations

Aurobindo Pharma Ltd. announced on Friday that its subsidiary, Aurolife Pharma LLC, has received a Form 483 with 11 observations from the US Food and Drug Administration following an inspection of its Raleigh plant in North Carolina, US.

The inspection took place from March 24 to April 10, 2025, according to a regulatory filing by the company.

At the conclusion of the inspection, the FDA issued the Form 483, noting 11 procedural observations. Aurobindo Pharma stated that it will provide a detailed response to the FDA within the required timeline, addressing each observation with appropriate corrective and preventive measures.

Asserting that it is committed to maintaining the highest standards of quality and compliance across all its operations, Aurobindo Pharma said, "We do not expect this development to have any material impact on the current business operations or existing supplies from this facility."

Shares of Aurobindo Pharma closed 2.31% higher at Rs 1,082.45 apiece on the NSE, compared to a 1.92% rise in the benchmark Nifty 50. The stock has fallen 0.55% in the last 12 months and 18.89% year-to-date.

Out of 29 analysts tracking the company, 22 have a 'buy' rating on the stock, three suggest 'hold' and four recommend 'sell' according to Bloomberg data. The average of 12-month analysts' price targets implies a potential upside of 35.2%.

(With PTI Inputs)