Hyderabad: Aurobindo Pharma, on Friday, May 3, said it has received seven observations from the United States Food and Drug Administration ( US FDA) for its unit-II formulation manufacturing facility located in Bhiwadi, Rajasthan.
The FDA conducted an inspection of the pharmaceutical company’s facility from April 25 to May 3, 2024. The US FDA has issued seven observations for the facility.
The facility is operated by Eugia Pharma Specialities Ltd, a wholly-owned subsidiary of Aurobindo Pharma. “The United States Food and Drug Administration (US FDA) inspected Unit-II, a Formulation manufacturing facility, of Eugia Pharma Specialities Ltd., a wholly-owned subsidiary of the Company, situated at Bhiwadi, Alwar, Rajasthan, from April 25th to May 3rd 2024,” the company said in an exchange filing.
The observations from the FDA are procedural in nature, according to Aurobindo Pharma. In response to this development, the company said that it would address these observations within the stipulated time frame.
Earlier last month, the US FDA conducted an inspection of its newly-operational injectable facility in Andhra Pradesh and issued three observations.
The shares of the pharma company ended 0.8% in the red on Friday, May 3. The stock has gained 6.19% in 2024 so far and 87.27% in one year.
