USFDA5 May 2026, 12:35 pm
Caplin Steriles Gets USFDA Nod for Calcium Gluconate Injection
AI Summary
Caplin Point Laboratories' subsidiary, Caplin Steriles Limited, received final approval from the USFDA for its ANDA Calcium Gluconate Injection USP. The injection, a generic version of Fresenius Kabi USA, LLC's drug, is indicated for treating acute symptomatic hypocalcemia in pediatric and adult patients. The US sales for Calcium Gluconate Injection USP were approximately $71 million for the 12 months ending March 2026, according to IQVIA (IMS Health).
Key Highlights
- Caplin Steriles received USFDA approval for Calcium Gluconate Injection USP.
- The drug is a generic version of Fresenius Kabi's Calcium Gluconate Injection.
- Calcium Gluconate Injection treats acute symptomatic hypocalcemia.
- US sales for the injection were approximately $71 million for the year ending March 2026.
- Caplin Steriles has 54 ANDA approvals in the USA.