Caplin Point Laboratories Limited announced that its subsidiary, Caplin Steriles Limited, has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Calcium Gluconate Injection USP. The medication, used to treat acute symptomatic hypocalcemia, represents a significant addition to the company’s sterile product portfolio. According to IQVIA data, the product recorded US sales of approximately $71 million for the 12-month period ending in March 2026.
Advancing Sterile Product Portfolio
Caplin Steriles Limited (CSL) has successfully secured final approval from the United States Food and Drug Administration (USFDA) for its Calcium Gluconate Injection USP. The approval covers multiple dosage formats, specifically 100 mg/mL in 10 mL, 50 mL, and 100 mL vials. This generic therapeutic equivalent version of the reference listed drug provides an important treatment option for both pediatric and adult patients suffering from acute symptomatic hypocalcemia.
Market Opportunity and Strategic Growth
The market for Calcium Gluconate Injection is robust, with US sales reaching approximately $71 million for the year ending March 2026. This milestone further cements Caplin Steriles’ position as a key player in the generic injectable market. To date, CSL has filed 54 ANDAs in the United States, all of which have received approval, demonstrating the company’s strong regulatory and manufacturing capabilities.
Commitment to Complex Injectables
Beyond this latest approval, Caplin Steriles is aggressively expanding its footprint. The company is currently developing a pipeline of 55+ simple and complex injectable and ophthalmic products, which it aims to file over the next 4 years. With state-of-the-art facilities and a growing international presence across markets like Australia, Canada, Mexico, and the Middle East, Caplin continues to prioritize high-quality growth in its sterile manufacturing division.
Source: BSE
