Date: November 11, 2026
Regulatory Action Disclosure
Inspection Details
The United States Food and Drug Administration (US FDA) conducted an inspection at Lannett Company LLC, a wholly owned step-down subsidiary of Aurobindo Pharma Limited. The inspection took place at the facility located at Seymour, IN, USA from August 17 to August 21, 2026.
Inspection Outcome
After completion of the inspection, the US FDA issued four observations to which the company responded within the stipulated time. The US FDA has now determined that the inspection classification of this facility is "official action indicated" (OAI).
Impact Assessment
According to the company's disclosure, there is no impact on the Company's financials or operations due to this regulatory action.
Company Commitment and Future Communications
The Company states it is committed to maintaining robust quality and compliance standards across its manufacturing facilities. Aurobindo Pharma will keep the Stock Exchanges informed of any further developments in this regard as required under applicable regulations.
Annexure Details
- Name of the authority: US Food and Drug Administration (US FDA), USA
- Nature and details of the action: US FDA conducted inspection at Lannett Company LLC from August 17-21, 2026 and issued four observations
- Date of receipt of communication: November 11, 2026
- Details of alleged violations: US FDA determined inspection classification as "official action indicated" (OAI)
- Financial/operational impact: No impact on Company's financials or operations