Mumbai, Sept. 3 -- 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...