Chennai, May 12, 2023: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), 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 (≤5 days) management of moderately severe acute pain. According to IQVIATM (IMS Health), Ketorolac Tromethamine Injection USP had US sales of approximately $53 million for the 12-month period ending December 2022.
Mr. C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited 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.”