Zydus Pain relief drug Ketorolac Tromethamine gets USFDA approval
Ahmedabad: 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.
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Zydus group is headquartered in Ahmedabad, India. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil.
Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and in the high-profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
