Caplin Point shines on getting USFDA nod for Etomidate injection

Caplin Point Laboratories’ subsidiary company, Caplin Steriles Limited has received final approval from United States Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Etomidate injection USP, 20 mg/10 ml (2 mg/ml) and 40 mg/20 ml (2 mg/ml) single-dose vial presentations. It is a generic therapeutic equivalent version of (RLD), AMIDATE (Etomidate) injection of Hospira Inc.  

Etomidate is a general anesthetic, used for the induction of general anesthesia as well as for the supplementation of sub-potent anesthetic agents. According to the data provided by IQVIA (IMS Health) for the 12- month period ending October 2020, Etomidate injection USP had US sales data of approximately USD 9 million. 

Caplin Steriles Ltd has developed and filed 19 ANDAs on its own & with partners, having a total of 11 approvals, so far. 

The company’s management has informed that Etomidate injection had frequently been on the shortage list in the US market and probably due to which, it has received this approval within 6 months. It plans to launch this product within a short period in the US. It is also working on a portfolio of 35 simple & complex injectable and ophthalmic products to be filed over the next 4 years, with addressable market size of USD 2.1 billion. 

Caplin Point’s long-term plan is to develop key starting materials (KSM), intermediates, and API for 80-100 small volume formulations such as injectables & hormones, for complete integration to the company’s front-end markets. Good progress is seen in the R&D of 150 new formulations, specifically targeting various therapeutic areas like injectables for hospitals, psychiatric and neuropsychiatric products for brand marketing, anti-cancer products, hormones & Penems. 

During the early morning session, Caplin Point was trading high by 3.9 per cent at Rs 515 from its previous close of Rs 495.80 on BSE.