India Pharma Outlook Team | Thursday, 04 September 2025
Caplin Point Laboratories Ltd revealed today that its subsidiary Caplin Steriles Ltd has received final approval from the United States Food and Drug Administration (USFDA) for its generic Milrinone Lactate in 5% Dextrose Injection. Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure.
The approval is for the abbreviated new drug application (ANDA) for Milrinone Lactate in 5% Dextrose Injection, in 20 mg/100 mL and 40 mg/200 mL single-dose infusion bags. This makes Caplin Steriles' product therapeutically equivalent to Sanofi Aventis US LLC's reference listed drug, PRIMACOR.
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Milrinone is one of the important treatment options in a hospital environment, allowing health professionals to treat patients that have severe heart failure, and helps to improve heart function. This approval represents a milestone as Caplin Steriles bolsters its injectables portfolio for an aggrieved and highly regulated US market, as it embarks on an expansion in the realm of critical care therapeutics.
As per IQVIA (IMS Health) data, Milrinone Lactate in 5% Dextrose Injection, generated sales of about USD 11 million from the US market for the 12 months ended July 2025. While the market size is likely small, the approval illustrates Caplin Steriles strategy to target specialised hospital based products with reliable demand and less competition.
This development highlights Caplin Point Laboratories’ continued progress in securing USFDA approvals and reinforces its commitment to bringing cost-effective generic alternatives to the US healthcare system.
