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Caplin Point’s arm gets USFDA’s approval for Calcium Gluconate Injection
May-05-2026

Caplin Point Laboratories’ subsidiary -- Caplin Steriles (CSL) 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. 

Calcium Gluconate Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. According to IQVIA (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.

Caplin Point Laboratories is the mid-sized company in India’s pharmaceutical sector to be engaged in the manufacture of APIs, finished formulations, research & development, clinical research, frontend generic presence in Latin America, brand marketing in Francophone Africa and an USFDA approved injectable facility.


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