Caplin Steriles Gets USFDA Nod for Generic Calcium Gluconate Injection in Multiple Strengths
New Delhi: Caplin Steriles Limited (CSL), a subsidiary of Caplin Point Laboratories Limited, has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Calcium Gluconate Injection USP (100 mg/mL) in 10 mL, 50 mL, and 100 mL vial presentations.
The approved product is a generic therapeutic equivalent of Fresenius Kabi USA, LLC’s reference listed drug (RLD) Calcium Gluconate Injection (NDA 208418).
Calcium Gluconate Injection is indicated for the treatment of acute symptomatic hypocalcemia in both pediatric and adult patients.
According to IQVIA data for the 12-month period ending March 2026, the approved product recorded sales of approximately USD 71 million in the United States market.
Caplin Point Laboratories stated that Caplin Steriles continues to strengthen its presence in regulated markets through expansion of its sterile and injectable portfolio.
Caplin Steriles Limited, which manufactures sterile pharmaceutical products, has approvals from multiple regulatory agencies including the USFDA, EU-GMP, ANVISA, and INVIMA. The company has developed and filed 54 ANDAs in the United States independently and through partners, with 54 approvals received so far, including acquired ANDAs.
The company is also developing a pipeline of more than 55 simple and complex injectable and ophthalmic products planned for filing over the next four years. In addition to the US market, Caplin Steriles has products filed and approved in several international markets including Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, South Africa, and Saudi Arabia.
Caplin One Labs Limited (COL), another subsidiary of Caplin Point Laboratories, is currently in its second year of oncology operations at its Kakkalur facility. The unit is engaged in multiple generic and specialty pharmaceutical projects targeting regulated and semi-regulated markets and currently holds five approved ANDAs for injectable products.
Caplin Point Laboratories is a Chennai-headquartered pharmaceutical company with a strong presence in emerging markets across Latin America and Africa. The company manufactures a wide range of finished dosage formulations and has featured multiple times in Forbes Asia’s “Best Under A Billion” list.
