Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets

Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets

By: IPP Bureau

Last updated : October 27, 2022 7:00 am



Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.


Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Ketorolac Tromethamine Tablets USP, 10 mg (USRLD: Toradol).

Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery. The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.

Ketorolac Tromethamine Tablets had annual sales of USD 17mn in the United States according to IQVIA data (IQVIA MAT Aug 2022).

The group now has 328 approvals and has so far filed over 428* ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences Limited USFDA

First Published : October 27, 2022 12:00 am