Themis gets DCGI approval of Remifentanil Hydrochloride 1mg/2mg injection for import and marketing
Drug Approval

Themis gets DCGI approval of Remifentanil Hydrochloride 1mg/2mg injection for import and marketing

Themis will market this drug with the brand name REMITHEM.

  • By IPP Bureau | February 18, 2023

Themis Medicare has received approval from Drug Controller General of India (DCGI) for import & marketing of Remifentanil 1 mg/2mg Powder for Concentrate for Solution for Injection.

The drug been approved for use as an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures, for continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting, and as an analgesic component of monitored anesthesia care in adult patients.

Themis will market this drug with the brand name REMITHEM.

Remifentanil is short-acting narcotic analgesic with a rapid onset & rapid offset of action that offers easy dose titration, predictable and precise intraoperative control, and reduced or rapidly reversed side effects. Due to its distinct pharmacokinetic and pharmacodynamic properties and rapid extra-hepatic clearance, Remifentanil has several applications in general anesthesia and in intensive care where rapid clearance of drug is beneficial.

Remifentanil was - first approved by USFDA in 1996. With the current approval in India, the long wait for the rapid acting narcotic analgesic is over. REMITHEM® will be imported by Themis and marketed in India soon by its well-trained sales team which is currently marketing a range of anesthesia and critical care products to hospitals across the country.

With a strong R&D backup, skilled domestic & export teams, and state-of-the-art manufacturing sites, the endeavour at Themis has always been to support the medical fraternity with solutions for major unmet medical needs and REMITHEM approval is yet another step in this direction.

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