Do you have the right choice of captopril?
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Last Update: 2017-06-16
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Source: Internet
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Author: User
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Recently, CFDA released the catalogue of six batches of reference preparations in three times, which caused a howl in the industry This article will take captopril tablet as an example to discuss the selection of reference preparation CFDA published the reference preparations of 12.5mg and 25mg captopril tablets in the fifth batch of reference preparations catalogue on June 9, and the manufacturer of the reference preparations is Japan's first three Co., Ltd The author has verified that the product is indeed listed in Japan, and it is included in the orange peel book as a reference preparation, and even given the original research status (see the arrow below) This seems to show the basis for CFDA to publish the reference preparation So why are the industry leaders still arguing about it? In order to explain this problem, the author will reveal the secret step by step through the principle of reference preparation selection, and verify the correctness of CFDA's publication of reference preparation 1 The first step to select the original research drug for domestic listing is to find the original research drug The author found that the original research enterprise of captopril was Squibb through the global drug R & D database of yaozhi.com Of course, the first three companies were also mentioned In order to further verify the correctness of the information obtained, the author also checked the indexes of cortellis and Merck (as shown in the figure below), basically verifying that the original research enterprise is Squibb In addition, the author found a very meaningful thing in the search process First three Co., Ltd also mentioned the original research as Squibb in the if document of drugs At this point, we can basically confirm that the original research of captopril is Squibb Further query data shows that there is no imported captopril preparation in China, only the Irish API Shanghai Shiguibao Pharmaceutical Co., Ltd of China and the United States has a real-estate captopril tablet, but it was found that the company did not declare the reference preparation by querying the reference preparation filing database Therefore, the first selection principle is inconsistent 2 As there is no imported captopril preparation in China, this article is also directly skipped 3 It seems that the drugs listed in the European Union, the United States and Japan as reference preparations can only be selected according to this article According to the FDA and PMDA, there are no captopril tablets listed in the U.S and Japan The reference preparation included in the American FDA orange peel book is Capoten of parpharmaceuticalinc, but the reference preparation has been withdrawn from the market The cortellis report also confirms this Although Squibb has obtained exclusive rights from most countries in the world, the exclusive rights of the United States and Japan have been obtained by par and Sankyo respectively According to the information, Squibb's captopril tablet was first approved by Ireland in 1981, with the trade name of Capoten and the current specifications of 25mg and 50mg In 1984, Squibb's captopril tablet was approved in France with the trade name of lopril, and the current specifications are 25mg and 50mg In addition, other European countries have also approved Squibb's captopril, such as the UK (25mg), Italy (25mg / 50mg), etc However, no specification of 12.5mg was found To sum up: the final results of the reference preparations of captopril tablets can be divided into two categories: the first, 12.5mg reference preparations selected from Japan's first three Co., Ltd The second, 25 mg / 50 mg two specifications of reference preparation to choose the products of Squibb in Ireland However, according to Article 7 of CFDA's notice on matters related to the conformity evaluation of quality and efficacy of generic drugs (Draft for comments) released on June 8, 12.5mg and 25mg captopril tablets of Squibb Shanghai, China and the United States can be selected as reference preparations, but this should be determined after the official draft is released At the same time, historical data shows that Shiguibao's captopril tablets were first listed in China in 1995, with the original approval number of hwyzz (1995) No 033002 The above is the author's point of view For specific information, please click to visit the Chinese orange peel book database (folk Edition) of yaozhi.com (more than 500 new varieties) At the same time, you can leave a message to get all references / materials of this article Original statement: This article is the original manuscript of yaozhi.com, welcome to reprint, reprint please indicate the source and author, thank you!
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