Exploring the way of generic drug

 "China's generic drugs to the world, enterprises should not only understand the laws and regulations of other countries, but also understand the competitive environment." Recently, on the theme Salon of "Opportunities and Challenges in the Global Vision of CPhI China 2019", Wang Jianying, Vice President of the Legal Affairs Department of Shanghai Ambisheng Pharmaceutical Technology Co., Ltd., said.

The pharmaceutical industry in the United States is well developed, and many discussions on salons are centered on the American market. At the meeting, Wang Jianying pointed out a rarely mentioned fact: under the pressure of insufficient health care budget and other factors, the United States required drug manufacturers to provide outpatient drugs to eligible health care institutions at substantially reduced prices, which aggravated the downward price of generic drugs under intense competition, while some drugs were supplied because of supply. Shortage due to business withdrawal. In this context, the Food and Drug Administration of the United States (FDA) requires companies to report marketing status, issue a withdrawal announcement 180 days before the formal withdrawal of products; at the same time, issue an exclusive list of drugs to speed up the review, give 180 days exclusive period protection and other measures to encourage pharmaceutical companies to develop and produce shortage drugs. Meng Xiaofeng, CEO of Renfu Epic Pharma, has a direct and profound feeling about the change of market competition environment of generic drugs in the United States. According to him, from 2015 to 2018, generic drug prices in the U.S. market declined, but subsequent product shortages attracted FDA attention. "From 2018 to 2019, the FDA often calls companies to ask if a shortage product can be supplied and what government assistance is needed." In Meng Xiaofeng's view, this change is an opportunity for pharmaceutical companies, as long as they have good products, they will have the opportunity to enter the U.S. market. Indian pharmaceutical companies occupy 30%-35% of the generic drug market in the United States. Some business representatives asked at the salon what angle Chinese enterprises should lay out in order to enter the United States and compete with Indian generic pharmaceutical companies. According to Wang Jianying, generic drugs in India are competitive and low in price. One important reason is the low cost of labor. She suggested that the integrated enterprise of API preparation production should optimize and improve APIs, and the pharmaceutical enterprise purchasing APIs should look for cheaper APIs in the market, and calculate the cost and benefit of changing suppliers in order to find a better API supply scheme.