Alkem Laboratories Limited has informed that US FDA has conducted a GMP and Pre-Approval inspection at the company’s manufacturing facility located at Indore from 1st - 7th July, 2022. At the end of the inspection, the company has received Form 483 with one observation with respect to ANDA filed for the products to be manufactured at the said plant. There is no data integrity observation.

This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observation.