Shares of Aurobindo Pharma Ltd. gained on Thursday, December 18, despite the US drug regulator issued Form 483 with five observations for one of its subsidiaries’ units.The company, in an exchange filing, said the US Food and Drug Administration (USFDA) inspected Unit-IV of APL Healthcare Ltd., a wholly-owned subsidiary of the company, in Andhra Pradesh, from December 8 to December 17, 2025.
At the end of the inspection, the US drug regulator issued the form 483 and observations, which the company said are procedural in nature.
Aurobindo Pharma said it will respond to the USFDA within the stipulated timelines.
The pharma company added that the development does not impact the financials and operations of the facility.Last week, the US drug regulator had issued another Form 483 with three observations to Aurobindo Pharma after inspecting its Unit-V, an active pharmaceutical ingredient (API) manufacturing facility of its wholly-owned subsidiary Apitoria Pharma Pvt. Ltd., in Telangana.
At the end of the inspection, the US drug regulator issued the form 483 and observations, which the company said are procedural in nature.
Aurobindo Pharma said it will respond to the USFDA within the stipulated timelines.
The pharma company added that the development does not impact the financials and operations of the facility.Last week, the US drug regulator had issued another Form 483 with three observations to Aurobindo Pharma after inspecting its Unit-V, an active pharmaceutical ingredient (API) manufacturing facility of its wholly-owned subsidiary Apitoria Pharma Pvt. Ltd., in Telangana.
The US drug regulator had inspected the facility from December 1 to December 12, 2025. Aurobindo Pharma said the observations were procedural and it would reply to the regulator in the stipulated timeframe.
Shares of Aurobindo Pharma are trading 1.3% higher at ₹1,208.9 apiece. The stock has declined 11% this year, so far.
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