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    Home > Medical News > Latest Medical News > This domestic pharmaceutical company has accelerated the layout of overseas markets, and this year has been approved with four American anda numbers

    This domestic pharmaceutical company has accelerated the layout of overseas markets, and this year has been approved with four American anda numbers

    • Last Update: 2016-08-26
    • Source: Internet
    • Author: User
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    Recently, Huahai pharmaceutical industry announced that it had received a notice from the U.S Food and Drug Administration (FDA) recently The Anda of voriconazole tablets declared by the company to the U.S FDA has been approved, and the company has the qualification to sell the products in the U.S market Voriconazole tablet is a broad-spectrum triazole antifungal drug, which is used to treat invasive aspergillosis, serious invasive infection caused by fluconazole resistant Candida (including Candida crenulatus) and serious infection caused by Actinomyces pedis and Fusarium Voriconazole tablets were developed by Pfizer and listed in the United States in 2002 According to the announcement, in 2015, the global sales volume of voriconazole tablets was about US $500 million, the sales volume of the US market was about US $100 million, and the sales volume of the domestic market was about RMB 1.59 billion As early as the first half of this year, Huahai Pharmaceutical Co., Ltd has been approved the Anda numbers of valsartan hydrochlorothiazide tablets and olmesartan ester hydrochlorothiazide tablets, plus the newly approved voriconazole tablets This year, Huahai Pharmaceutical Co., Ltd has obtained three American anda numbers, with a total of 25 American anda numbers approved At the same time, the author expects that there will be more anda numbers approved in the second half of this year The frequent application of overseas preparations by Huahai pharmaceutical industry marks that the company's preparation R & D and application have reached a new level, which is inseparable from the huge R & D strength and standardized preparation production line behind Huahai pharmaceutical industry On May 23, 2014, South Sichuan Branch of Huahai Pharmaceutical Co., Ltd passed the U.S FDA certification with zero defects, which is the fifth time since Huahai Pharmaceutical Co., Ltd first passed the U.S FDA certification with zero defects in 2004 FDA certification has laid a good foundation for the company to obtain anda number, which is conducive to further consolidating and expanding the share of export products in the United States and other international markets By inputting relevant contents into the drug registration and acceptance database and the Chinese clinical trial database, the author found that the generic drug registration application of Huahai pharmaceutical in 2016 was as follows: We see that in the first half of 2016, Huahai pharmaceutical had only one application for amlodipine besylate API, no application for related preparations, and no amlodipine related clinical trials were found in the Chinese clinical trial database Therefore, the author makes two conjectures: (1) Huahai pharmaceutical may imitate the previous mode of lisinopril tablets, purchase the relevant anda number, and then change the API supplier to produce lisinopril tablets with its own APIs and sell them in the U.S market (2) Huahai pharmaceutical industry may apply for amlodipine related preparations in China and then submit an anda application to FDA after approval, so as to enter the U.S market No matter what kind of possibility, it can't be denied that Huahai pharmaceutical industry is increasing product R & D and application, accelerating the layout of overseas markets, increasing overseas market share, and striving to develop into a truly global generic multinational company.
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