Ajanta Pharma Gets 5 USFDA Observations for Paithan Facility
New Delhi: Ajanta Pharma Limited has informed that the US Food and Drug Administration (USFDA) has completed its inspection of its manufacturing facility located at Paithan, Maharashtra.
The inspection was conducted from April 13 to April 21, 2026. At the end of the inspection, the US FDA issued a Form 483 with five observations.
Form 483 is issued when investigators observe conditions that may constitute deviations from current Good Manufacturing Practices (cGMP). However, it is important to note that the issuance of Form 483 does not represent a final regulatory determination.
The company further stated that it will submit its response to the US FDA within the stipulated timeline.
The disclosure has been made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
Such inspections are critical for pharmaceutical companies as they determine compliance with US regulatory standards and can impact exports to the US market. The company’s response to these observations will be closely monitored for further regulatory action.
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