Aurobindo Pharma Unit-IV Clears US FDA Inspection with 5 Procedural Observations

Aurobindo Pharma Limited announced the completion of a United States Food and Drug Administration (US FDA) inspection at Unit-IV of its wholly-owned subsidiary, APL Healthcare Limited. The inspection ...

Aurobindo Pharma Limited announced the completion of a United States Food and Drug Administration (US FDA) inspection at Unit-IV of its wholly-owned subsidiary, APL Healthcare Limited. The inspection took place from December 08 to December 17, 2025, at the facility located in Palchur village and part of Palepalem Village, Naidupeta Mandal, SPSR Nellore District, Andhra Pradesh. Following the inspection, the US FDA issued a Form 483 with five observations. The company has stated that these observations are procedural in nature and that it will provide a response to the US FDA within the stipulated timelines. Aurobindo Pharma reiterated its commitment to upholding the highest quality manufacturing standards across all its global facilities. The company has also indicated that this development is not expected to have any impact on the financial or operational activities of the facility. They will keep the stock exchanges informed of any further developments.

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Why is Aurobindo Pharma Limited in the news today?

Aurobindo Pharma Limited (AUROPHARMA) is in the news due to the us fda inspection concluded with procedural observations, which are not uncommon. while the company has committed to responding, the immediate impact is neutral as no significant issues were highlighted that would negatively affect operations or financials.

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Aurobindo Pharma Unit-IV Clears US FDA Inspection with 5 Procedural Observations

December 18, 2025, 04:35 AM

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Aurobindo Pharma Limited announced the completion of a United States Food and Drug Administration (US FDA) inspection at Unit-IV of its wholly-owned subsidiary, APL Healthcare Limited. The inspection took place from December 08 to December 17, 2025, at the facility located in Palchur village and part of Palepalem Village, Naidupeta Mandal, SPSR Nellore District, Andhra Pradesh.

Following the inspection, the US FDA issued a Form 483 with five observations. The company has stated that these observations are procedural in nature and that it will provide a response to the US FDA within the stipulated timelines.

Aurobindo Pharma reiterated its commitment to upholding the highest quality manufacturing standards across all its global facilities. The company has also indicated that this development is not expected to have any impact on the financial or operational activities of the facility. They will keep the stock exchanges informed of any further developments.

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