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Caplin Point Laboratories Limited ( (IN:CAPLIPOINT) ) just unveiled an update.
Caplin Steriles, the sterile injectables arm of Caplin Point Laboratories, has received final U.S. FDA approval for its Abbreviated New Drug Application for Calcium Gluconate Injection USP in multiple vial sizes, a generic equivalent to Fresenius Kabi’s reference product. The drug treats acute symptomatic hypocalcemia in pediatric and adult patients, targeting a U.S. market with about $71 million in annual sales.
The approval strengthens Caplin Steriles’ growing U.S. injectable portfolio and underscores the group’s capability to compete in regulated markets beyond its traditional Latin American and African base. This regulatory milestone supports Caplin Point’s strategy of diversifying revenue streams globally and may enhance its positioning among hospital-focused generic injectable suppliers, benefiting both the parent company and its expanding network of subsidiaries.
More about Caplin Point Laboratories Limited
Caplin Point Laboratories is a fast-growing pharmaceutical company focused on emerging markets in Latin America and Africa, offering a broad range of finished dosage formulations from advanced manufacturing facilities. Its subsidiary Caplin Steriles specializes in sterile injectables, holds multiple U.S. and international regulatory approvals, and has built a sizable ANDA portfolio across regulated and non-regulated markets.
Caplin’s strong track record of consistent growth in cash flows, profitability, and revenues over the past 15 years has earned repeated recognition on Forbes Asia’s “200 Best Under a Billion” list. The group is expanding into oncology through Caplin One Labs, which is in its second year of operations and already holds approved injectable ANDAs for both regulated and other global markets.
Average Trading Volume: 6,276
Technical Sentiment Signal: Buy
Current Market Cap: 130B INR
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