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(18 Dec 2025, 10:59)

Aurobindo Pharma arm gets Form-483 with five observations

Aurobindo Pharma said that the US Food and Drug Administration (US FDA) has completed the inspection of APL Healthcare’s Unit-IV, wholly owned subsidiary, located at Palchur village, Andhra Pradesh (AP).


The inspection was conducted from 8 December to 17 December 2025. At the end of the current inspection, a ‘Form 483’ was issued with 5 observations which are procedural in nature, and the company said that it will respond to the US FDA within the stipulated timelines.

Aurobindo Pharma is principally engaged in the manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals, and related services.

The company’s consolidated net profit increased 3.8% to Rs 848.45 crore on 7.7% increase in net sales to Rs 8,236.96 crore in Q2 FY26 over Q2 FY25.

The scrip rose 0.36% to Rs 1,197.40 on the BSE.

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