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Lupin gets two observations from USFDA for Somerset facility

16 Jan 2023 , 09:16 AM

Lupin Limited has informed to the exchanges that the USFDA inspected Lupin’s Somerset, New Jersey, U.S.A. manufacturing facility from January 2, 2023 to January 13, 2023. 

According to the filing, the inspection closed with issuance of a Form-483 with two observations. 

‘We are addressing the observations comprehensively and will work with the U.S. FDA to resolve these issues at the earliest’, the company said in a statement.

It further added, ‘We uphold quality and compliance with utmost importance and are committed to be compliant with CGMP standards across all our facilities.’

On Monday early morning trade, Lupin was trading at Rs750 per share lower by 0.74% on the BSE.

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