Zydus Lifesciences gets final approval from USFDA for Ketorolac Tromethamine Tablets

25 Oct 2022 Evaluate

Zydus Lifesciences 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 $ 17mn in the United States.  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 (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

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