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Home Health USFDA issues import alert on Jubilant Pharmova's Roorkee plant - ET HealthWorld

USFDA issues import alert on Jubilant Pharmova’s Roorkee plant – ET HealthWorld


REUTERS/Dado Ruvic/File Photo

Drug firm Jubilant Pharmova on Thursday said the US health regulator has placed an import alert on its Roorkee-based manufacturing facility, affecting its exports to the American market. The US Food and Drug Administration (USFDA) has taken the action after conducting an inspection of the formulations plant in March this year, the drug maker said in a regulatory filing.

Earlier, the Roorkee facility had received an OAI (Official Action Indicated) from the USFDA in December 2018, followed by a warning letter in March 2019.

The company will engage with the agency to resolve the import alert at the earliest and ensure Current Good Manufacturing Practice (cGMP) compliance, Jubilant Pharmova noted.

The agency has exempted Meclizine tablets, Olanzapine orally disintegrating tablets, Risperidone orally disintegrating tablets, Spironolactone tablets, and Valsartan tablets from the import alert subject to the company meeting a few conditions, it added.

The products that got impacted due to the import alert contributed to less than 3 per cent of FY21 total revenues for the company, the drug firm stated.

Shares of the Noida-based drug firm closed 6.10 per cent down at Rs 705.80 apiece on BSE. MSS DRR DRR





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