Caplin Steriles gets USFDA approval for Norepinephrine Bitartrate Injection

Caplin Steriles Limited, a subsidiary company of Caplin Point Laboratories Limited, has received final approval from 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. This generic therapeutic equivalent version of LEVOPHED injection of Hospira Inc. is used for the restoration of blood pressure in adult patients with acute hypotensive states.

Norepinephrine Bitartrate Injection

This approval is a significant milestone for Caplin Steriles Limited as it allows the company to provide a more affordable alternative to the branded version of the drug. According to IQVIATM (IMS Health), Norepinephrine Bitartrate Injection USP had US sales of approximately $40 million for the 12-month period ending June 2023. The approval of Caplin Steriles Limited’s ANDA is expected to contribute to the availability of affordable healthcare options for patients in the United States.

Caplin Steriles Limited is committed to providing high-quality and affordable healthcare solutions to patients around the world. The company’s focus on research and development, quality control, and regulatory compliance has enabled it to become a leading player in the pharmaceutical industry. With this latest approval, Caplin Steriles Limited continues to demonstrate its commitment to providing affordable and accessible healthcare to patients in need.

In conclusion, the approval of Caplin Steriles Limited’s ANDA for Norepinephrine Bitartrate Injection USP is a significant development in the pharmaceutical industry. This approval will allow the company to provide a more affordable alternative to the branded version of the drug, which will benefit patients in the United States. Caplin Steriles Limited’s commitment to research and development, quality control, and regulatory compliance will continue to drive its success in the pharmaceutical industry and benefit patients around the world.

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