Aurobindo Pharma Gets USFDA Form 483 for Unit IV, Shares Gain 1.5%

18 Dec 2025 , 12:13 PM

Shares of Aurobindo Pharma Ltd rose on Thursday, December 18, even after the US drug regulator issued a Form 483 with observations for one of its subsidiary units. As of 12:09 PM, the share price of Aurobindo Pharma is trading at ₹1,211, which is a 1.58% gain in the NSE.

In an exchange filing, the company said the US Food and Drug Administration conducted an inspection at Unit IV of APL Healthcare Ltd, a wholly owned subsidiary, located in Andhra Pradesh.

The inspection at the Andhra Pradesh facility was carried out between December 8 and December 17, 2025. At the conclusion of the inspection, the USFDA issued a Form 483 with five observations. Aurobindo Pharma said the observations are procedural in nature and do not have any impact on the financials or operations of the unit. The company added that it will submit its response to the regulator within the stipulated timelines.

Separately, the company said the USFDA had issued another Form 483 last week following an inspection of Unit V, an active pharmaceutical ingredient manufacturing facility operated by Apitoria Pharma Pvt Ltd, its wholly owned subsidiary in Telangana. The inspection at the Telangana facility was conducted from December 1 to December 12, 2025.

Aurobindo Pharma stated that the three observations issued for Unit V were also procedural in nature and that it would respond to the US drug regulator within the prescribed timeframe.

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