Hot Pursuit     20-Sep-23
Caplin Point's subsidiary gets US FDA approval for blood pressure restoration drug
Caplin Point Laboratories informed that Caplin Steriles has been granted final approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) Norepinephrine Bitartrate injection.

The said injection is a generic therapeutic equivalent version of (RLD), LEVOPHED injection of Hospira Inc.

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients with acute hypotensive states.

According to IQVIATM (IMS Health), Norepinephrine Bitartrate injection USP had US sales of approximately $40 million for the 12-month period ending June 2023.

Caplin Steriles, a subsidiary of Caplin Point Laboratories, is a niche sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP and ANVISA. Caplin Steriles has developed and filed 31 ANDAs in USA on its own and with partners, with 24 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.

Caplin Point Laboratories is engaged in the business of pharmaceuticals - producing, developing and marketing wide range of generic formulations and branded products and exporting to overseas market.

The company's consolidated net profit jumped 29.2% to Rs 102.11 crore in Q4 FY23 as compared with Rs 79.06 crore in Q4 FY22. Net sales rose 14.8% year on year to Rs 389.28 crore in Q4 FY23 over Q4 FY22.

The scrip shed 0.70% to currently trade at Rs 1034.40 on the BSE.

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