Caplin Point Lab gains after receiving USFDA nod for Milrinone Lactate injection

Caplin Point Laboratories rose 1.90% to Rs 2,169.70 after the company 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.

The approval covers two dosage forms?20 mg/100 mL (0.2 mg/mL) and 40 mg/200 mL (0.2 mg/mL)?in single-dose infusion bags. The product is a generic therapeutic equivalent version of the Reference Listed Drug (RLD), PRIMACOR in Dextrose 5%, by Sanofi Aventis US LLC.

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

Caplin Point Laboratories is a pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. The company also has a growing presence in the regulated markets such as US through its subsidiary Caplin Steriles and Caplin Steriles USA Inc.

The company reported an 11.2% year-on-year (YoY) increase in revenue from operations to Rs 510.2 crore and a 20.7% YoY rise in profit after tax (PAT) to Rs 150.8 crore in Q1 FY26.

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