Caplin Steriles Gets USFDA Nod For Ketorolac Tromethamine Injection

Caplin Steriles, a subsidiary of Caplin Point Laboratories 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, the company said in a regulatory filing on Friday.

Ketorolac Tromethamine Injection USP is a nonsteroidal anti-inflammatory drug (NSAID), indicated for the short-term (≤5 days) management of moderately severe acute pain. According to IQVIATM (IMS Health), Ketorolac Tromethamine Injection USP had US sales of approximately USD 53 million for the 12-month period ending December 2022. 

C. C. Paarthipan, Chairman of Caplin Point Laboratories commented “Our regulated markets business continues to grow at a robust pace, and this new approval will help augment the growth. We have also received a few approvals from other markets such as Canada and Australia and we look forward to launches there within this year too.”