Caplin Steriles bags USFDA nod for Rocuronium Bromide Injection
Rocuronium Bromide Injection is a neuromuscular blocking agent, indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
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) Rocuronium Bromide Injection, 10 mg/mL in 5 mL and 10 mL Multi-dose Vials.
The product is a generic therapeutic equivalent version of (RLD), ZEMURON Injection, of Organon USA Inc.
Rocuronium Bromide Injection is a neuromuscular blocking agent, indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
According to IQVIA (IMS Health), Rocuronium Bromide Injection had US sales of approximately $53 million for the 12-month period ending September 2022.
Mr. C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited commented “This is an important product in our anesthesia portfolio for global markets, and we look forward to launching it in the US in the coming months.”
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Caplin Steriles Ltd, 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, EUGMP and ANVISA. Caplin Steriles Limited, has developed and filed 29 ANDAs in USA on its own and with partners, with 19 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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