Caplin Steriles Gets USFDA Approval For Norepinephrine Bitartrate Injection

Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited, has been granted 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, a generic therapeutic equivalent version of (RLD), LEVOPHED injection of Hospira Inc., the company on Wednesday announced through an exchange filing.

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 US Dollar 40 million for the 12-month period ending June 2023.

About Caplin Steriles Limited

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 Point Laboratories Ltd shares

The shares of Caplin Point Limited on Wednesday at 11:22 am IST were at Rs 1,037.80, down by 0.57 percent.