Zhejiang Anglikang Pharmaceutical Co.Ltd(002940) on January 20, it was announced that the company learned through the drug evaluation center (CDE) of the State Drug Administration that the isoflurane API of Haixi pharmaceutical, a holding subsidiary, had passed the CDE technical review. Now, the registration information publicity platform of CDE API, pharmaceutical excipients and drug packaging materials shows that the registration number is changed to “a”, that is, the raw materials approved for use in listed preparations.
The company said that the variety passed the CDE technical review, which will further enrich the company’s product line and enrich the varieties of API.
Isoflurane API was originally developed by Baxter International Co., Ltd. for the induction and maintenance of general anesthesia for in-hospital surgery and outpatient surgery of adult and pediatric patients.
Haixi pharmaceutical submitted and accepted the drug registration application for isoflurane API in November 2017. Isoflurane API has passed the CDE technical approval, and it can be produced and sold in China only after it is publicized that the GMP compliance inspection result of Fujian drug administration is “qualified”.
Up to now, isoflurane has completed GMP compliance inspection and is waiting for Fujian drug administration to publicize the GMP compliance inspection results of this variety.
