Lindal Group announced that the Chinese National Medical Product Administration’s (NMPA) Center for Drug Evaluation (CDE) has listed the drug master file (DMF) for Lindal’s 20 mm male MDI metering valve as active following review. The company said that “the inclusion of the KHFA valve marks significant progress in Lindal headway into the Chinese aerosol dispensing market.”
Now that the DMF has been activated by the CDE, the valve can be imported into China for use in a marketed product. As a result, a pharmaceutical company that wants to seek marketing approval for an MDI in China could now incorporate the KHFA valve into a product in development for that market.
Lindal Group Marketing Manager Kashif Choudhry commented, “This is an exciting step for us. We are now looking ahead to the next stage towards approval when the submission will be revised following the first drug application. The listing represents great advancement and demonstrates our readiness for the next phase in this promising market.”
Read the Lindal Group press release.
