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Caplin Steriles Ltd., a subsidiary of Chennai-based Caplin Point Laboratories Ltd, has been granted final approval from the US drug regulator for its Abbreviated New Drug Application (ANDA) Norepinephrine Bitartrate Injection USP, 4 mg/4 mL (1 mg/mL) single-dose vial.
Norepinephrine Bitartrate is a generic therapeutic equivalent version of RLD, LEVOPHED injection of Hospira Inc.
In a regulatory filing, Caplin Point Laboratories said, 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.
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Caplin Steriles is into injectable and ophthalmic manufacturing.
Its manufacturing plant, located in Gummidipoondi near Chennai, is approved by several regulatory agencies such as USFDA, EU-GMP and ANVISA. Earlier this month, Caplin Steriles received an Establishment Inspection Report (EIR) from USFDA for one of its units.
Caplin Steriles has developed and filed 31 ANDAs in the USA on its own and with partners, with 24 approvals so far. The Company is also working on a portfolio of over 40 simple and complex Injectable and Ophthalmic products that it intends to file over the next 4 years.
Meanwhile, shares of Caplin Point were trading flat at ₹1,037.60 on NSE.
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