Thursday, June 20, 2024

Health

Aurobindo Pharma arm Eugia's manufacturing unit gets 'official action indicated' status by USFDA

IANS | May 25, 2024 03:59 PM

NEW DELHI: Drug maker Aurobindo Pharma on Saturday announced that the US Food and Drug Administration (FDA) has classified Eugia Pharma Specialities' (a wholly owned subsidiary of the company) formulation manufacturing facility -- Unit III, as 'Official Action Indicated (OAI)'.

According to the company, the USFDA conducted an inspection at Unit III of Eugia Pharma Specialities, situated in Sangareddy District, Telangana, from January 22 to February 2.

"Subsequently, the USFDA has determined the inspection classification status of this facility as Official Action Indicated, " Aurobindo Pharma said in a regulatory filing.

"The company remains committed to working closely with the USFDA and continues to enhance its compliance on an ongoing basis, " it added.

OAI means objectionable conditions or practices were found, and/or the firm's response was not satisfactory, so regulatory and/or administrative actions will be recommended.

In an Enforcement Report published earlier this month, the USFDA informed that Aurobindo Pharma is recalling products in the US due to manufacturing issues.

The drug maker recalled 13, 605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg) from the US market. Clorazepate Dipotassium Tablets are used to treat anxiety.

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