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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.

Peers
Company Name CMP
Sun Pharma. Inds. 1853.00
Dr. Reddys Labs. 1200.40
Cipla 1404.00
Lupin 2098.00
Zydus Lifesciences 1180.00
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