Caplin Point Laboratories’ arm gets USFDA’s nod for Ketorolac Tromethamine Injection

12 May 2023 Evaluate

Caplin Point Laboratories’ subsidiary company -- Caplin Steriles (Caplin) has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 mg/mL Single-dose Vial, a generic therapeutic equivalent version of (RLD), TORADOL injection of Roche.

Ketorolac Tromethamine Injection USP is a nonsteroidal anti-inflammatory drug (NSAID), indicated for the short-term management of moderately severe acute pain. According to IQVIA (IMS Health), Ketorolac Tromethamine Injection USP had US sales of around $53 million for the 12-month period ending December 2022.

Caplin Point Laboratories is engaged mainly in manufacturing a wide range of Ointments, Creams and other External application preparations in addition to the regular segments of pharmaceutical formulations.

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