USFDA Concludes Inspection of Aurobindo Pharma Subsidiary with 2 Observations
New Delhi: Aurobindo Pharma Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed an inspection at Auroactive Pharma Private Limited, its wholly owned subsidiary, with the inspection concluding with two observations.
The company disclosed the development under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, stating that the inspection was conducted at the subsidiary's manufacturing facility located at Sy Nos. 231, 285 to 291, Sancham Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh – 523409, from June 22, 2026, to June 26, 2026.
According to the filing, Auroactive Pharma Private Limited manufactures Active Pharmaceutical Ingredients (APIs) and Pharmaceutical Formulation Intermediates. The US FDA inspection concluded on June 26, 2026, with two observations, which the company said will be responded to within the stipulated timeline.
Aurobindo Pharma stated that it remains committed to maintaining the highest quality manufacturing standards and will keep the stock exchanges informed of any further developments relating to the inspection.
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The company further clarified that the inspection resulted in two observations, which constitute the details of the observations communicated by the regulator. It reiterated that appropriate responses will be submitted to the US FDA within the prescribed timeframe.
According to the Aurobindo Pharma regulatory filing, the inspection of Auroactive Pharma Private Limited's API and pharmaceutical formulation intermediates manufacturing facility in Srikakulam, Andhra Pradesh, concluded with two observations, and the company has stated that there is no impact on its financials or operations as a result of the inspection. The filing also confirms that the company will continue to update the stock exchanges if there are any further developments related to the inspection.
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