Caplin Steriles gains USFDA approval for heart failure drug

Caplin Steriles Limited, 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 Milrinone Lactate in 5% Dextrose Injection. This approval covers 20 mg/100 mL (0.2 mg/mL) and 40 mg/200 mL (0.2 mg/mL) single-dose infusion bags, a generic equivalent of Sanofi Aventis US LLC's Primacor in Dextrose 5%.

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. According to IQVIA™ (IMS Health), US sales for Milrinone Lactate in 5% Dextrose Injection were approximately $11 million for the 12-month period ending July 2025.

Caplin Steriles Limited, a fast-growing sterile product manufacturer, has developed and filed 51 ANDAs, with 40 approvals to date. The company also has a portfolio of over 40 injectable and ophthalmic products planned for filing over the next four years.