The Japanese pharmaceutical enterprise: Sanyo Chemical Laboratories Co., Ltd.’s refusal of the NMPA’s inspection was disclosed and exposed by the NMPA on July 31. The detailed written report is not disclosed, however, the NMPA mentioned on its website: “As the enterprise expressed in writing its refusal of the onsite inspection, the enterprise was deemed as refusing the inspection according to the Provisions on the Administration of Overseas Inspection of Drugs and Medical Devices.”
Source: NMPA
My first reaction to this news was, “Will there be a mandatory recall?” Then, I came to know that the product involved was an API upon inquiry. Then I started to worry whether it would result in an interruption of supply to Chinese pharmaceutical enterprises. We have been aware of how arrogant API enterprises could be, for example, an enterprise dared to directly throw away the USB flash drive of the NMPA’s inspection team, which was something other types of pharmaceutical enterprises would never dare to do. And we know how far China will punish such kind of deed: even up to RMB100 million is possible.
Then, why this Japanese pharmaceutical enterprise did it? With this question, I searched the related data and discovered that only this enterprise sells imported methoxyphenamine hydrochloride, i.e., only it exports this drug to China.
Source: NMPA
Then, how about the Chinese pharmaceutical enterprises? The results seem surprising. There is also only one Chinese API pharma companies, and there are ten formulation enterprises.
Source: NMPA
Here is the question: is the number of enterprises producing that API really this small or does the NMPA not timely update the data? I choose to believe the former. Please note that the following descriptions are based on data disclosed by the NMPA. If there is any omission, please urge the drug administration to update the data. Any comments are welcome.
There are two possible reasons for this Japanese enterprise’s daring to refuse the inspection in writing. Firstly, they do not take this market seriously because the export volume is too small. Is this possible? Definitely. In particular, the export and transportation costs have increased greatly during this pandemic, therefore, the enterprise might choose to give up. If this was the case, it would indirectly show the absolute market share of Yangzhou No. 3 Pharmaceutical in methoxyphenamine hydrochloride variety. Can we check which enterprises use the API of this Japanese enterprise and which en...
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