Caplin Steriles Gets USFDA Approval For Cisatracurium Besylate Injection

Caplin Steriles Limited (Caplin), a Subsidiary company of Caplin Point Laboratories Limited, 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, single dose vials and multi dose vials (preserved), a generic therapeutic equivalent version of (RLD), NIMBEX injection of AbbVie Inc., the company announced today through an exchange 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.

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.

“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. This approval will augment our growth plans for Caplin Steriles this year and the years going forward,” said C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited.

Caplin Point Laboratories Ltd Shares

The shares of Caplin Point Laboratories on Monday at 3:12 pm IST were at Rs 812.70, up by 1.58 percent.