Caplin Steriles Secures Landmark USFDA Approval for Milrinone Lactate in Infusion Bags, Boosting Generic Portfolio

Caplin Steriles Limited, a prominent subsidiary of Caplin Point Laboratories Limited, has announced a significant achievement with the granting of final approval from the United States Food and Drug Administration (USFDA). The approval is for its Abbreviated New Drug Application (ANDA) for Milrinone Lactate in 5% Dextrose Injection, available in two single-dose infusion bag sizes: 20 mg/100 mL and 40 mg/200 mL.

This approval marks the company’s 40th ANDA approval to date and allows it to launch a generic therapeutic equivalent to the reference listed drug (RLD), PRIMACOR in Dextrose 5%, by Sanofi Aventis US LLC. The milestone underscores Caplin Steriles’ robust manufacturing capabilities and regulatory prowess, which is also recognized by international bodies like EU-GMP, ANVISA, and INVIMA.

The newly approved product is a critical medication for the short-term intravenous treatment of patients with acute decompensated heart failure, a serious condition where the heart’s ability to pump blood effectively is suddenly compromised. According to data from IQVIA™ (IMS Health), the U.S. sales for Milrinone Lactate in 5% Dextrose Injection were approximately $11 million for the 12-month period ending July 2025. This approval opens up a valuable new market for Caplin Steriles, reinforcing its commitment to providing high-quality, cost-effective generic alternatives to meet critical healthcare needs.