FDA Drug Master File
Zhengzhou Aoshine Pharmaceutical Technology Corp.,Ltd has deposited a type III DMF through FDA in 2012.
Halogenated Butyl Rubber Stopper for Injection : DMF No. 25949
Halogenated Butyl Rubber Stopper for Freeze-Drying Injection: DMF No. 25945
Halogenated Butyl Rubber Stopper for Injection Sterile Powder: DMF No. 25950
The DMF contains all relevant info for Drug Application in USA, it is regularly maintained to include all new developments.
Ready For Sterilization (RFS)
RFS products are washed with WFI and packed in a Cleanroom GMP Class C.
Products are packed in steam sterilizable bags to be used by customers without any further handling prior to autoclaving.