Worry! The new crown epidemic affects the supply of APIs in the pharmaceutical industry of the United States and India

In the United States, there are concerns in the pharmaceutical industry from time to time that pharmaceutical companies rely on China to provide key APIs Now, the outbreak of a new coronavirus has reignited that fear "In the supply chain of APIs, if there is a problem in China, it will be a global problem," said an FDA consultant In China, the increasing number of cases and various measures to prevent the epidemic have strained the resources of medical supplies in China Before that, most of the protective products (such as masks) available in the market had been used up, and many enterprises had already begun to resume manufacturing products Photo source: gettyimages, however, as the virus continues to spread in China and other places, a new problem arises: China gives priority to its own medical resources and the use of APIs under the situation of surging domestic demand, or the epidemic further stimulates the ban on international trade, can the United States and other regions of the world maintain adequate drug supply? Thousands of small pharmaceutical companies in India were first affected It is reported that Indian pharmaceutical manufacturers rely heavily on APIs or active pharmaceutical ingredients purchased in China, mainly including antibiotics, of which penicillin G (penicillin G) and other products based on the ingredient, such as amoxicillin and ampicillin), tetracycline and vitamin C, D, are of great importance All of these pharmaceutical ingredients are based on the use of a fermentation based manufacturing process, in which China has become a global leader Therefore, Indian media pointed out that the new coronavirus epidemic makes the future development of China's API supply situation full of uncertainty At present, China has extended the Spring Festival holiday to the middle of February If these measures continue further, Indian drug manufacturers (mainly formula factories) that use Chinese imported drug ingredients may be affected "If the holidays are extended, most of India's import dependent units may face challenges," said Sudarshan Jain, Secretary General of the pharmaceutical alliance of India Large companies may be less affected because they tend to have enough inventory, but there are about 8000 small companies in India with turnover of less than 1 billion rupees (about 90 million yuan), of which 4000-5000 are antibiotic drug manufacturers If imports are restricted or prices rise, they may be hard to survive " A spokesman for lupin, a large generic pharmaceutical company in India, said: "if the holiday is extended and the uncertainty increases, it may also start to affect the larger pharmaceutical companies in India India is totally dependent on penicillin G produced in China, not only to meet the needs of the Indian market, but also to supply products based on this ingredient to the United States " The dependence on Chinese APIs has raised concerns in the United States about the FDA's spokesman, who said no notice of drug shortages caused by the new coronavirus has yet been received, but industry concerns do exist The reason is that the U.S imports not only pharmaceutical ingredients from China, but also from India (about 40% of generic drugs), where most of India's products are based on Chinese raw materials China has always been a major supplier of APIs to the United States, especially generic drugs, which are widely used (at present, generic drugs account for more than 90% of the total prescriptions in the U.S market.) China accounted for 70.4% of U.S antibiotic imports in 2013, according to the U.S International Trade Commission "Right now, it's probably 97 percent, and it's dominant." Gary Cohn, former chief economic adviser to President trump, said In general, about 80% of the active ingredients used in the production of finished drugs in the United States come from China According to FDA data, 13% of pharmaceutical factories in China now produce pharmaceutical ingredients sold in the United States In the past decade, China has become an important player in the market of active pharmaceutical ingredients In addition, China's domestic market purchasing power also worries the United States The drug was sold out online and in pharmacies immediately after state media reported last week that Shuanghuanglian could "suppress" the new coronavirus China's internal consumption is so large that it may not have enough surplus for the rest of the world at all Although most of China's drug manufacturers have gathered in Zhejiang, Jiangsu, Shandong and other provinces on the east coast, the production, supply and transportation of APIs are relatively reduced with the development of the epidemic nationwide and even partial regional blockade Photo source: tianyancha reported that Lonza, a Swiss cdmo company, is extending its spring festival holidays at four Chinese factories to prevent the spread of the epidemic The company also imposed restrictions on travel and return to and from China, requiring two weeks of family segregation By February 4, Lonza company had stopped the production and operation of a pharmaceutical preparation and pyromellitic dianhydride factory in Nanjing, Jiangsu Province, a small molecule API and niacin factory in Nansha, Guangdong Province, a capsule and microbial control solution factory in Suzhou, Jiangsu Province, and a biological preparation factory in Guangzhou, Guangdong Province under construction "As responsible employers, we have taken steps to protect our employees and any third parties," the company said So far, the extension of the shutdown time has only resulted in a limited supply disruption But as the epidemic continues to affect us, we are also assessing the impact of potential delays in raw materials and manufactured goods " Last week, another large cdmo company in Wuxi, Jiangsu, said: "the company is implementing a business continuity plan to mitigate any potential risks and ensure that its products are not affected by the outbreak We hope to be able to resume operations after the holiday and will continue to produce key medicines for customers around the world " Multinational pharmaceutical companies are also preparing Pfizer spokesman said Friday (January 31), "the company always controls our drug supply Pfizer has 40 own sites and more than 200 suppliers around the world, which provide drugs and storage as needed At present, most of the finished products and APIs come from countries other than China " "We have a business continuity plan that includes ensuring critical inventory in major distribution centers outside high-risk areas and working with external suppliers to deal with unforeseen events," a Johnson spokesman said "The company has an API that meets global demand from China, has an existing inventory, and has the opportunity to source from another location," said a Roche representative Reference: 1 Coronavirus outbound China shutdown to hit Indian drug manufacturers httpsww.businesstoday.insectorsharmacoronavirus-outbound-china-shutdown-hit-indian-drug-manufacturerstory395005.html 2 'the time to world is now' the coronavirus in China could thread Pharma's ingradient sourcing httpswww.statnews.compharmalot20200127china-coronavirus-pharmaceutical-ingredients 3、As China battles coronavirus, Should other countries world about their drug supply httpsww.fiercepharma.compharma-asia-china-battles-coronavirus-should-other-countries-world-about-their-drug-supply 37 statement: this point of view only represents the author, not the position of drug intelligence network, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.