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Aurobindo Pharma gets warning letter from US FDA for Andhra Pradesh unit

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The company received a warning letter from the United States Food and Drug Administration (US FDA) related to their unit XI, active pharmaceutical ingredient (API) manufacturing facility at Srikakulam

Drug firm Aurobindo Pharma said that it has received a warning letter from the US health regulator for one of its units in Srikakulam district, Andhra Pradesh, which was the subject of an inspection earlier this year.

The company has received a warning letter from the United States Food and Drug Administration (US FDA) relating to our unit XI, active pharmaceutical ingredient (API) manufacturing facility situated at Srikakulam District, Andhra Pradesh. This action follows the earlier inspection of the site by the US FDA in February 2019, Aurobindo Pharma said in BSE filing.

Aurobindo Pharma said it “believes the existing business from this facility will not be impacted”.

The drug firm, however, did not provide any details of the contents of the warning letter received from the regulator.

“We will be engaging with the regulator and are fully-committed in resolving this issue at the earliest. The company is also committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe,” the company added.

Shares of Aurobindo Pharma were trading 5.82 per cent lower at Rs 590.40 apiece on BSE.

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