Caplin Point subsidiary gets USFDA nod for cisatracurium besylate injection

Caplin Steriles Limited (Caplin), a Subsidiary company of Caplin Point Laboratories on Monday said in the filing that it 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.

Mr. C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited commented “We’ve been consistent with our filings and also happy to receive approvals on time. We’re creating a healthy portfolio of products that we will launch not only in the US but in global markets as well.

The company's chairman said this approval will augment our growth plans for Caplin Steriles this year and the years going forward.

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, the company said in the filing. 

According to IQVIATM (IMS Health), Cisatracurium Besylate Injection USP had US sales of approximately $35 million for the 12- month period ending December 2022.

Source: Media reports