Aurobindo Unit 1 likely under US FDA scanner
The US FDA is likely to inspect the company Aurobindo Pharma's Unit 1 facility, sources told CNBC-TV18. It is an API plant, and it has an official action indicated status which was issued by the US FDA in May 2019. This basically increases the chance of any kind of adverse regulatory action on the facility.
The US FDA is likely to inspect the company Aurobindo Pharma's Unit 1 facility, sources told CNBC-TV18. It is an API plant, and it has an official action indicated status which was issued by the US FDA in May 2019. This basically increases the chance of any kind of adverse regulatory action on the facility.
Now the US FDA inspection is expected to be from August 2 to August 7. It is expected to be an onsite inspection, not a virtual inspection.
Unit 1 is an API plant where it is used both for captive consumption and external sales.
Aurobindo has quite a lot of pending regulatory issues to reckon with. For example -- their subsidiary in the US received a warning letter in October 2020. Unit 7 was classified as an official action indicated status in January 2020. Unit 11 has a warning letter, Unit 1 and Unit 9 have official action indicated statuses.
CNBC-TV18’s Ekta Batra has more details.
(Edited by : Priyanka Rathi)
First Published: Jul 27, 2021 4:38 PM IST
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