Aurobindo Pharma subsidiary completes US FDA inspection with two observations

Aurobindo Pharma subsidiary completes US FDA inspection with two observations


Aurobindo Pharma informed stock exchanges that the United States Food and Drug Administration (US FDA) has completed an inspection at Auroactive Pharma Private Limited, a wholly owned subsidiary of the company.

According to the regulatory filing, the inspection was conducted at the subsidiary’s manufacturing facility located in Sancham Village, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, from June 22 to June 26.

The facility manufactures Active Pharmaceutical Ingredients (API) and pharmaceutical formulation intermediates.

The company stated that the inspection concluded with two observations. Aurobindo Pharma said the observations would be addressed and responded to within the stipulated timeline.

In its disclosure, the company added that there is no impact on its financials or operations arising from the inspection outcome.

The filing was submitted to both the National Stock Exchange of India (NSE) and BSE Limited under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Aurobindo Pharma said it remains committed to maintaining high quality manufacturing standards and would keep the stock exchanges informed of any further developments related to the matter.

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