Low BP treatment: Caplin Steriles bags USFDA nod for Norepinephrine Bitartrate Injection

Published On 2023-09-20 08:00 GMT   |   Update On 2023-10-12 11:06 GMT

Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval by the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Norepinephrine Bitartrate Injection USP, 4 mg/4 mL (1 mg/mL) Single-Dose Vial.The product is a generic therapeutic equivalent version of (RLD),...

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Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval by the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Norepinephrine Bitartrate Injection USP, 4 mg/4 mL (1 mg/mL) Single-Dose Vial.

The product 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.

Read also: USFDA nod to Caplin Steriles Cisatracurium Besylate Injection

Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a niche sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP and ANVISA. Caplin Steriles Limited, 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. 

Read also: Caplin Steriles bags USFDA nod for Ketorolac Tromethamine Injection



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