Shanghai Securities News China Securities Network News (reporter Han Yuanfei) Enhua Pharmaceutical announced at noon on December 30 that the company recently received the "Notice of Approval of Drug Clinical Trials" approved by the State Food and Drug Administration, and the company's injectable refentanil hydrochloride meets the relevant requirements of drug registration, and agrees that this product carries out early postoperative analgesia (under the supervision of anesthesiologists) in anesthesia intensive care unit patients and as a component of analgesics for regulating anesthesia care in adult patients.
Remifentanil hydrochloride for injection is used for general anesthesia induction and maintenance of analgesia in general anesthesia, and is a nationally controlled narcotic drug. Enhua Pharmaceutical obtained the production approval of remifentanil hydrochloride product for injection in 2014, which was produced and listed in the same year, and in June 2021, the drug passed the consistency evaluation of generic drug quality and efficacy. In October 2021, according to the indications of the same variety of drugs at home and abroad, the company applied for the addition of early postoperative analgesia (under the supervision of anesthesiologists) in patients with refentanil hydrochloride anesthesia or intensive care unit for injection and the indications for regulating anesthesia care in adult patients as an analgesic components, and was accepted.
![Announcement #Enhua Pharmaceutical a new drug of anesthesia class 1 was approved for clinical trials[fig]](data:image/gif;base64,R0lGODlhAQABAIAAAP///wAAACwAAAAAAQABAAACAkQBADs=)