Caplin Point Laboratories’ arm gets USFDA nod for Milrinone Lactate Injection

19 Apr 2021 Evaluate

Caplin Steriles (Caplin), a Subsidiary Company of Caplin Point Laboratories, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Milrinone Lactate Injection USP, 10 mg/10 mL (1 mg/mL), 20 mg/20 mL (1 mg/mL), 50 mg/50 mL (1 mg/mL), Single-dose vial presentation, a generic therapeutic equivalent version of (RLD), PRIMACOR Injection, 1 mg/mL, of Sanofi-Aventis U.S. LLC.

Milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. According to IQVIA (IMS Health), Milrinone Lactate Injection had US sales data of approximately $24 million for the 12-month period ending Dec 2020, for both the Vial and Bag presentations, the latter of which is under development at Caplin Steriles.

Caplin Point Laboratories is engaged mainly in manufacturing a wide range of Ointments, Creams and other External application preparations in addition to the regular segments of pharmaceutical formulations.

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