Aurobindo Pharma announced the conclusion of a United States Food and Drug Administration (US FDA) inspection at its wholly-owned subsidiary, Eugia Pharma Specialities Ltd.’s Unit-I, a formulation manufacturing facility. The inspection took place from February 16 to February 27, 2026. The inspection resulted in 4 observations. Aurobindo confirmed it remains committed to high quality standards and will submit a response to the US FDA within the stipulated timelines. Importantly, the company stated there is no impact on financials or operations.
US FDA Inspection Concluded at Subsidiary Facility
Aurobindo Pharma has officially notified stock exchanges regarding the conclusion of a key regulatory inspection. The United States Food and Drug Administration (US FDA) inspected Unit-I, a formulation manufacturing facility belonging to Eugia Pharma Specialities Ltd., which is a wholly owned subsidiary of the Company.
The inspection was conducted at the facility located in Kolthur Village, Shameerpet Mandal, Ranga Reddy, Telangana, and spanned from February 16 to February 27, 2026. The communication detailing the outcome was received by the company on February 27, 2026.
Inspection Outcome and Response
The inspection concluded with the identification of 4 observations. Aurobindo Pharma stated its commitment to resolving these findings and confirmed that it will respond to the US FDA within the stipulated timelines.
The Company stressed its ongoing commitment to maintaining the highest quality manufacturing standards across all its global facilities. Furthermore, Aurobindo confirmed that, based on the current situation, there is no impact on the Company’s financials or operations due to the findings.
Annexure Summary
The disclosure included an annexure summarizing the details:
- Authority: US Food and Drug Administration (US FDA), USA.
- Action/Details: Inspection of Eugia Pharma Specialities Ltd.’s Unit-I Formulation manufacturing facility.
- Observations: The inspection concluded with 4 observations.
- Financial Impact: There is no impact on the Company’s financials or operations.
Source: BSE
