Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited (BSE: 524742, NSE: CAPLIPOINT), has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) of Milrinone Lactate in 5% Dextrose Injection. The approved strengths include 20 mg/100 mL (0.2 mg/mL) and 40 mg/200 mL (0.2 mg/mL) single-dose infusion bags. This product is the generic version of PRIMACOR (Sanofi Aventis US LLC).
Milrinone is used for the short-term intravenous treatment of acute decompensated heart failure. As per IQVIA (IMS Health), Milrinone Lactate in 5% Dextrose Injection recorded US sales of around $11 million for the 12-month period ending July 2025.
Caplin Steriles has built a strong presence in the US with 51 ANDA filings and 40 approvals to date. The company also plans to expand its portfolio with 40+ injectable and ophthalmic products in the pipeline. Beyond the US, Caplin Steriles has secured multiple regulatory approvals in markets such as Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, and Saudi Arabia.
