The United States Food & Drug Administration (USFDA) is currently inspecting Unit 9 of Aurobindo Pharma, sources told CNBC-TV18. Sources added that the inspection began last week at this facility, which makes bulk drugs (APIs) and certain intermediates for pharmaceutical formulations. The Unit 9 plant of Aurobindo is located at Hatnoora in Hyderabad.
The Unit 9 received an Official Action Indicated status from the USFDA in 2019. An OAI classification means that the USFDA may withhold approvals of any pending products until outstanding observations are resolved.
Aurobindo Pharma's unit 9 is used in the manufacturing of intermediaries.
Aside of Unit 9, the company's unit 11 has been classified as a Voluntary Action Indicated status, according to the USFDA site. The regulator had issued a warning letter to this unit in June 2019.
An approval with Voluntary Action Indicated (VAI) means objectionable conditions or practices were found at the manufacturing unit but USFDA does not recommend any administrative or regulatory action.
The company is yet to hear from the USFDA for Unit 11.
Aurobindo Pharma has been in the news after its Director, P Sarath Chandra Reddy, had been arrested by the Enforcement Directorate. On the company's earnings call, the management said that Reddy will remain a non-executive director and his responsibilities will be reallocated.
Shares of Aurobindo Pharma are trading 0.7 percent higher at Rs 491.
First Published: Nov 15, 2022 12:48 PM IST
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