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List of Chemical Generic Reference Formulations (the 23rd batch)

Date: 2019-08-30
浏览次数: 295

On August 28, the drug evaluation center of the State Food and Drug Administration issued the publication of the catalogue of the 23rd batch of chemical generic reference formulations, with the publication date from August 28 to September 10. This time, there are 318 product specifications, involving 169 drugs (see the attached table at the end of the article for details). Among them, 170 injection specifications accounted for 53.5%.


2224 reference formulations have been published, with 630 injection varieties


According to statistics, up to now, FDA has released a total of 2224 reference formulations in 23 batches (among which, the 23rd batch is the published quantity).


According to several batches of reference formulations in recent years, new dosage forms are gradually included. The twenty-first batch of reference formulations was first included in the list of injections, inhalants and oral film formulations, and the twenty second batch of reference formulations was first included in the list of patches and paste formulations. It is believed that with the development of consistency evaluation, more dosage forms will be included in the list of reference preparations. It can be seen from the inclusion of the referenceformulation that the consistency evaluation of the enterprise or the imitation of pharmaceutical hot products, inhalants, oral soluble films, patches and pastes are expected to become new hot spots of domestic formulations.


At present, 17 injections have been evaluated, and the consistency evaluation of injections has been accelerated


From the statistical data, the injection appeared for the first time  from the 21st batch of reference formulation catalog, so far, a total of 630 injections have been involved. Among them, there are 196 injections in the 21st batch, 264 injections in the 22nd batch and 170 injections in the 23rd batch.



enclosure: 

List of Chemical Generic Reference Formulations (the 23rd batch)List of Chemical Generic Reference Formulations (the 23th batch)



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