Caplin Steriles Ltd receives final approval from USFDA for ANDA Cisatracurium Besylate Injection USP

Caplin Steriles Limited (Caplin), a Subsidiary company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), 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.

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. This approval will augment our growth plans for Caplin Steriles this year and the years going forward."

Shares of Caplin Point Laboratories Limited was last trading in BSE at Rs. 800.30 as compared to the previous close of Rs. 808.85. The total number of shares traded during the day was 9136 in over 786 trades.

The stock hit an intraday high of Rs. 809.00 and intraday low of 791.00. The net turnover during the day was Rs. 7302167.00.

Source : Equity Bulls

Keywords

CaplinPointLaboratories INE475E01026 CaplinSteriles FinalApproval USFDA 3ANDA CisatracuriumBesylateInjection