Caplin Steriles Secures USFDA Final Approval for Calcium Gluconate Injection

Caplin Steriles Secures USFDA Final Approval for Calcium Gluconate Injection​

Caplin Steriles Limited (CSL), a subsidiary of Caplin Point Laboratories Limited, has received final approval from the United States Food and Drug Administration (USFDA). This approval pertains to its Abbreviated New Drug Application (ANDA) for Calcium Gluconate Injection USP.

The approved product is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) originally developed by Fresenius Kabi USA, LLC (NDA 208418). The injectable drug, marketed as Calcium Gluconate Injection USP, is indicated for the treatment of acute symptomatic hypocalcemia in pediatric and adult patients. The product is available in multiple formats, including 100 mg/mL in 10 mL, 50 mL, and 100 mL Vials.

Market intelligence indicates the significant demand for this product. According to IQVIA TM (IMS Health), the US sales of Calcium Gluconate Injection USP for the 12-month period ending March 2026 reached approximately $71 million.

Operational Capacity and Portfolio Expansion​

Caplin Point Laboratories Limited is established as a fast-growing pharmaceutical company, with a business model centered on emerging markets in Latin America and Africa. The parent company is recognized for its history of consistent growth in cash flows, profitability, and revenues over the last 15 years.

Caplin Steriles Limited, which manufactures sterile products, holds approvals from several major regulatory bodies, including US FDA, EU-GMP, ANVISA, and INVIMA. The company has demonstrated a robust pipeline of generic drugs. CSL has developed and filed a total of 54 ANDAs in the USA, securing 54 approvals to date (including acquired ANDAs).

CSL’s strategic focus extends beyond the US market. The subsidiary manages a portfolio of 55+ simple and complex Injectable and Opthalmic products, slated for filing over the next four years. Furthermore, the company has secured multiple product approvals in various non-US markets, including Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, South Africa, and Saudi Arabia.

In addition to CSL, Caplin One Labs Limited (COL), another subsidiary of Caplin Point Laboratories Limited, operates an oncology unit in Kakkalur. COL currently has five approved ANDAs for injectable products and maintains several ongoing projects for generic and specialty drug development in both regulated and other markets.

CAPLIPOINT Stock Price Movement​

Shares of Caplin Point Laboratories Limited are gaining momentum in live trading, currently at ₹1750.9 as of 12:53 PM, rallying by 0.84%. The equity sees significant market interest, bolstered by a strong trading volume of 39,374 shares.