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Aurobindo Pharma unit gets warning letter from USFDA

Aurobindo pharma unit gets USFDA warning

An active pharmaceutical ingredient (API) manufacturing facility of Aurobindo Pharma in Srikakulam district of Andhra Pradesh has been issued a warning letter by the U.S. Food and Drug Administration (USFDA).

“This action follows the earlier inspection of the site by the USFDA in February 2019,” the drug maker said in a regulatory filing on Friday. It, however, did not share details of the warning letter.

Noting that the company had received the warning letter dated June 20 relating to Unit XI, Aurobindo Pharma said the existing business from this facility would not be impacted.

“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 filing said.

In May, the regulator had issued letter to Aurobindo Pharma classifying the inspections concluded at the company’s API facilities of Unit I and XI and intermediates facility of unit IX in February as official action indicated (OAI). The company had said it was confident of the OAI classifications not having an impact on disruption of the supplies or the revenue from the operations of these facilities.

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Printable version | Feb 23, 2020 12:06:23 PM | https://www.thehindu.com/business/aurobindo-pharma-unit-gets-warning-letter-from-usfda/article28102343.ece

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