Aurobindo Pharma Limited announced the completion of a US FDA inspection at its wholly-owned subsidiary, Auroactive Pharma Private Limited. The inspection covered facilities manufacturing Active Pharmaceutical Ingredients (API) and Pharmaceutical Formulation Intermediates. The audit resulted in 2 observations, which the company will address within the stipulated timeframe. Aurobindo reiterated its commitment to maintaining high quality manufacturing standards.
US FDA Inspection Completed at Subsidiary
AUROBINDO PHARMA LIMITED has disclosed the conclusion of an inspection conducted by the United States Food and Drug Administration (US FDA) at its wholly-owned subsidiary, Auroactive Pharma Private Limited. This facility, located in Srikakulam District, Andhra Pradesh, is involved in the manufacturing of Active Pharmaceutical Ingredients (API) and Pharmaceutical Formulation Intermediates.
Inspection Details and Outcomes
The inspection took place from June 22, 2026, to June 26, 2026. The US FDA’s assessment resulted in a total of 2 observations. Aurobindo Pharma Limited has committed to providing responses to these observations within the regulatory stipulated time. The company emphasized its ongoing dedication to upholding the highest standards in its manufacturing processes.
Impact on Operations
Aurobindo Pharma Limited stated that the inspection, and its outcomes, will not have any impact on the company’s financial performance or its overall operations. The company will continue to inform the stock exchanges should any further significant information arise regarding this matter.
Source: BSE
