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人福医药:芬太尼系列产品年收入超 20 亿元,未向美国出口

医药魔方 医药魔方 来源:医药魔方
2018-12-02
人福医药 芬太尼
原文

12月2日,人福医药发布公告,称关注到网络关于芬太尼的讨论,提及芬太尼类物质在美国的走私滥用情况以及中美双方将高度关注并采取有效措施应对等情况。


人福医药指出,枸橼酸芬太尼注射液、枸橼酸舒芬太尼注射液、注射用盐酸瑞 芬太尼制剂及原料药(合成“芬太尼系列产品”)是公司主要产品,由公司控股子公司宜昌人福药业有限责任公司(简称“宜昌人福”,公司持有其 67%的股权)生产、 销售,现就公司芬太尼系列产品相关情况说明如下: 


1、公司芬太尼系列产品属于受到严格管制的麻醉药品。我国《药品管理法》及《麻 精药品管理条例》对该类药品的实验研究、生产、经营、使用、储存、运输等环节的管 理做了全面、系统的规定,宜昌人福严格按照相关规定执行,特别是在国内流通方面, 实行“定点生产企业→全国性批发企业(有资质)→区域性批发企业(有资质)→医疗 机构”的购销流程”。 


同时,国家药品监督管理局按照 1988 年联合国禁止非法贩运麻醉药品和精神药品公约对本国麻醉药品和精神药品的生产及进出口严格管控。宜昌人福根据相关规定,制定 《特殊管理药品出口销售管理》及《特殊管理药品发运管理》等管理规程,严控客户资 质、运输途径,并且在获得进口国官方颁发的进口许可证、国家药品监督管理局颁发的 出口许可证以及其它资料齐全的情况下,按法律规定的程序报关,进行产品出口及销售。 


2、2017 年度,宜昌人福芬太尼系列产品销售收入超过人民币 20 亿元;其中出口销售收入约为人民币 500 万元,主要出口至斯里兰卡、厄瓜多尔、菲律宾、土耳其等国家或地区,采购方均为进口国的国家官方采购机构、当地官方认可的具有管制药品经营资 质的公司或当地具有管制药品生产资质的工厂。截至目前,宜昌人福没有任何芬太尼类物质(中间体、原料或制剂)出口到美国。


人福医药指出,公司严格遵守国家有关麻醉药品的法律法规,积极拥护世界各国和地区对麻醉药品 的严格管制,始终恪守“企业公民”原则,努力创造和谐社会环境。


机器翻译

On December 2, Renfu Pharmaceutical issued an announcement stating that it was concerned about the discussion on fentanyl on the Internet, mentioning the smuggling and abuse of fentanyl substances in the United States and the fact that both China and the United States will pay close attention and take effective measures to deal with the situation.

Renfu Pharmaceutical pointed out that fentanyl citrate injection, sufentanil citrate injection, remifentanil hydrochloride for injection and raw material medicine (synthetic "fentanyl series products") are the company's main products, and the company's holding subsidiary Yichang Renfu Pharmaceutical Co., Ltd. (abbreviated as "Yichang Renfu", the company holds 67% of its equity) Production and sales, the company's fentanyl series products are described as follows:

1, the company's fentanyl series is a strictly controlled narcotic drugs.China's "Drug Administration Law" and "Regulations on the Administration of Hemp Drugs" have made comprehensive and systematic provisions on the management of experimental research, production, operation, use, storage, and transportation of such drugs. Yichang Renfu strictly follows the relevant regulations. Implementation, especially in terms of domestic circulation, implements the purchase and sales process of "fixed-point production enterprises → national wholesale enterprises (qualified) → regional wholesale enterprises (qualified) → medical institutions".

At the same time, the State Drug Administration strictly controls the production, import and export of narcotic drugs and psychotropic substances in China in accordance with the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.In accordance with the relevant provisions, Yichang Renfu formulated the "Special Management Drug Export Sales Management" and "Special Management Drug Delivery Management" and other management procedures, strictly controlled the customer's qualifications and transportation routes, and obtained the import license issued by the official of the importing country, the export license issued by the State Drug Administration, and other materials. In the case of completeness, the customs shall be declared according to the procedures stipulated by law to export and sell products.

2. In 2017, the sales revenue of Yichang Renfu Fentanyl series products exceeded RMB 2 billion; among them, the export sales revenue was approximately RMB 5 million, which was mainly exported to Sri Lanka, Ecuador, the Philippines, Turkey and other countries or regions, and the purchasers were all national official procurement agencies of the importing countries, local officially recognized companies with regulatory pharmaceutical business qualifications, or local factories with regulatory pharmaceutical production qualifications.As of now, Yichang Renfu has not exported any fentanyl substances (intermediates, raw materials or preparations) to the United States.

Renfu Medicine pointed out that the company strictly abides by the laws and regulations of the State on narcotic drugs, actively supports the strict control of narcotic drugs in various countries and regions of the world, and always adheres to the principle of "corporate citizenship" and strives to create a harmonious society environment.

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