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