The US health regulator has placed an import alert on its Roorkee-based manufacturing facility, affecting its exports to the American market said Jubilant Pharmova the drug firm on Thursday.
After conducting an examination of the formulations plant in March this year, the US Food and Drug Administration (USFDA) has taken the action, the drugmaker said in a regulatory filing. In December 2018, the Roorkee facility had received an OAI (Official Action Indicated) from the USFDA, followed by a warning letter in March 2019.
Jubilant Pharmova further noted that the company will engage with the agency to resolve the import alert at the soonest and ensure the Current Good Manufacturing Practice (cGMP) compliance.
It added that the agency has relieved 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.
The drug company stated, the products that got impacted due to the import alert, contributing to less than 3 per cent of FY21 total revenues for the company.
Shares of the Noida-based drug firm closed 6.10 per cent down at Rs 705.80 apiece on BSE.