Caplin Point Laboratories’ arm gets USFDA’s approval for Cisatracurium Besylate Injection

12 Jun 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) Cisatracurium Besylate Injection USP, 10 mg/5 mL (2 mg/mL) and 200 mg/20 mL (10 mg/mL) Single-dose Vials; and 20 mg/10 mL (2 mg/mL) Multiple-dose Vials (Preserved)., a generic therapeutic equivalent version of (RLD), NIMBEX injection of AbbVie Inc.

Cisatracurium Besylate Injection USP is a nondepolarizing skeletal neuromuscular blocker, indicated as an adjunct to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgical procedures. According to IQVIATM (IMS Health), Cisatracurium Besylate Injection USP had US sales of approximately $35 million for the 12- month period ending December 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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