Caplin Point Laboratories’ arm gets USFDA’s approval for Rocuronium Bromide Injection

03 Mar 2023 Evaluate

Caplin Point Laboratories’ subsidiary -- Caplin Steriles has been granted final approval from 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, 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 around $53 million for the 12-month period ending September 2022.

Caplin Point Laboratories is engaged mainly in manufacturing a wide range of Ointments, Creams and other External application preparations in addition to the regular segments of pharmaceutical formulations.

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