The United States Food and Drug Administration has granted final approval to Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereinafter referred to as “Zydus”) for Loperamide Hydrochloride Capsules USP, 2 mg (USRLD: Imodium® Capsules) (USFDA). Loperamide hydrochloride capsule is used to control and relieve the symptoms of acute nonspecific diarrhoea and chronic diarrhoea caused by inflammatory bowel disease. The drug will be produced at the group’s formulation manufacturing facility in Ahmedabad’s SEZ (India).
In the United States, Loperamide Hydrochloride Capsules USP, 2 mg had annual sales of USD 34.7 million (IQVIA MAT, January 2023). Since the beginning of the filing process in FY 2003-04, the group has received 356 approvals and has filed over 440* ANDAs.