Caplin Steriles Ltd granted final approval from USFDA for ANDA Rocuronium Bromide Injection

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) 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 IQVIATM (IMS Health), Rocuronium Bromide Injection had US sales of approximately $53 million for the 12-month period ending September 2022.

Mr. C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited commented "This is an important product in our anesthesia portfolio for global markets, and we look forward to launching it in the US in the coming months."

Shares of Caplin Point Laboratories Limited was last trading in BSE at Rs. 655.55 as compared to the previous close of Rs. 659.00. The total number of shares traded during the day was 1001 in over 111 trades.

The stock hit an intraday high of Rs. 665.00 and intraday low of 654.15. The net turnover during the day was Rs. 659782.00.

Source : Equity Bulls

Keywords

CaplinPointLaboratories INE475E01026 CaplinSteriles FinalApproval USFDA ANDA RocuroniumBromideInjection