Caplin Steriles gets USFDA approval for Etomidate Injection USP

Chennai, December 24, 2020: Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT) Caplin Steriles Limited, 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) Etomidate injection USP, 20 mg/10 mL (2 mg/mL) and 40 mg/20 mL (2 mg/mL)

Single-dose vial presentations, a generic therapeutic equivalent version of (RLD), AMIDATE (Etomidate) Injection, of HOSPIRA INC. According to IQVIATM (IMS Health), Etomidate injection USP had US sales data of approximately $9 million for the 12- month  period ending Oct 2020.  Caplin Steriles  Limited,  has developed  and filed 19 ANDAs on its own and with partners, with 11 approvals so far.

Etomidate is a general anesthetic, used for the induction of general anesthesia and for the supplementation of subpotent anesthetic agents.

Mr.C.C.Paarthipan, Chairman of Caplin Point Laboratories Limited commented “We  understand Etomidate injection has frequently been on the shortage list in the US, which is probably the reason why we received this approval within 6 months. We hope to launch this product within a short period in the US”

The Company is also working on a portfolio of 35 simple and complex Injectable and Ophthalmic products, to be filed over the next 4 years, with an addressable market size of USD 2.1 Billion


Caplin Point Laboratories Limited is a fast-growing pharmaceutical Company with a unique business model catering predominantly to emerging markets of Latin America and Africa. Caplin Point has state of the art manufacturing facilities that cater to a complete range of finished dosage forms. The Company’s Subsidiary Caplin Steriles Limited caters to the Regulated Markets for Injectable and Ophthalmic products.

Caplin Point Laboratories Limited has been selected on Forbes Asia’s “200 Best Under a Billion” list for three consecutive years (2014, 2015 & 2016), and was recently awarded “The Emerging Company of 2018” and “Business Excellence Award for 2019” by Economic Times.