Caplin Steriles Ltd granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA

Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL (0.2 mg/mL) and 40 mg/200 mL (0.2 mg/mL) Single-dose Infusion Bags, 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 Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a fast-growing sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA. Caplin Steriles Limited has developed and filed 51 ANDAs (including two ANDA's acquired in the month of April 2025) in USA on its own and with partners, with 40 approvals so far. The Company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products that it intends to file over the next 4 years. The company also has multiple products filed with several approvals in non-US markets such as Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, Saudi Arabia etc.

Shares of Caplin Point Laboratories Limited was last trading in BSE at Rs. 2160.10 as compared to the previous close of Rs. 2129.30. The total number of shares traded during the day was 11280 in over 1676 trades.

The stock hit an intraday high of Rs. 2187.90 and intraday low of 2111.15. The net turnover during the day was Rs. 24346458.00.

Source : Equity Bulls

Keywords

CaplinPointLaboratories INE475E01026 CAPLINSteriles Pharmaceuticals USFDA ANDA Approval