US FDA inspection at Unit-VI concluded with three procedural observations
AUROPHARMA · price
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US FDA inspected Unit-VI, an API manufacturing facility of wholly owned subsidiary Apitoria Pharma Private Limited in Andhra Pradesh, from August 24 to 28, 2026. The inspection concluded with three observations, all described as procedural in nature. The company will respond to the US FDA within the stipulated timeline and reaffirmed its commitment to quality and compliance.
Mildly positive as only procedural observations were noted. No major compliance flags, though FDA response is still pending.