Haizheng pharmaceutical's simvastatin tablets first passed the consistency evaluation

Recently, Haizheng pharmaceutical released an enterprise announcement that Hanhui Pharmaceutical Co., Ltd (hereinafter referred to as "Hanhui pharmaceutical"), a holding subsidiary of Zhejiang Haizheng Pharmaceutical Co., Ltd., learned through the website of the drug evaluation center of the State Drug Administration that the simvastatin tablet of Hanhui Pharmaceutical (hereinafter referred to as "the drug") has passed the quality and efficacy consistency evaluation of generic drugs Simvastatin is a kind of blood lipid lowering drug It is suitable for children with primary hypercholesterolemia, including heterozygous familial hypercholesterolemia, hyperlipidemia or mixed hypercholesterolemia, homozygous familial hypercholesterolemia, coronary heart disease with hypercholesterolemia, and heterozygous familial hypercholesterolemia The original manufacturer of this product is Merck & Co., which was approved to be listed in 1989 with the trade name of Zocor; in 2000, it was approved to be imported from China with the trade name of Merck sharp & Dohme limited and the trade name of Shujiang As of the announcement date, the main manufacturers of the same variety in China include more than 30 manufacturers including Yangzijiang Pharmaceutical Group Sichuan Hairong Pharmaceutical Co., Ltd., Zhejiang Jingxin Pharmaceutical Co., Ltd., Shandong Luoxin Pharmaceutical Group Co., Ltd According to the IMS database, the global sales volume of simvastatin tablets in 2018 is about 1938.52 million US dollars, of which the sales volume in China is about 84.6671 million US dollars; the global sales volume in the first quarter of 2019 is about 41.0867 million US dollars, of which the sales volume in China is about 17.4649 million US dollars Hanhui pharmaceutical is the first enterprise in China to pass the consistency evaluation of the product The conformity evaluation of the generic drug of Haizheng pharmaceutical was accepted by the State Drug Administration on September 14, 2018 Up to now, the company has invested about 7.9 million yuan in the drug consistency evaluation project.