Chennai: Caplin Steriles Limited (CSL), 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) Calcium Gluconate Injection USP (100 mg/mL in 10 mL, 50 mL and 100 mL Vials), a generic therapeutic equivalent version of the Reference Listed Drug (RLD) from Fresenius Kabi USA, LLC (NDA 208418).
Calcium Gluconate Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. According to IQVIATM (IMS Health), Calcium Gluconate Injection USP, (100 mg/mL in 10 mL, 50 mL and 100 mL Vials) had US sales of approximately $71 million for the 12-month period ending March 2026.
