Chennai, April 19, 2021: Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT) Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited, 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 TM (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.
Mr. C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited commented “We’re expecting approvals for 3 more products this Quarter and we’re working on launches for 9 products in the next few months from the site.”