Caplin Steriles, a Chennai-based Caplin Point Laboratories Ltd. subsidiary, has received final approval from the United States Food and Drug Administration (USFDA) for its Rocuronium Bromide Injection.
The USFDA has approved it's Abbreviated New Drug Application (ANDA) for Rocuronium Bromide Injection, 10 mg/mL in 5 mL and 10 mL multi-dose vials, 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.
In February, Caplin Steriles received US FDA's final approval for Carboprost Tromethamine Injection, used to treat severe bleeding after childbirth (postpartum).
Caplin Steriles Ltd is a niche sterile product manufacturing company approved by several regulatory agencies such as US FDA, EU- GMP, and ANVISA. It has developed and filed 29 ANDAs in the USA by itself 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 four years.
