China’ s annual exports of $100 billion worth of active pharmaceutical ingredients (API) to the US are encountering disruptions as the coronavirus assault continues, industry insiders said.
The US Food and Drug Administration (FDA) issued a statement on Thursday, saying “a (US) manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list.”
This shortage, related to a site affected by the coronavirus, is due to an issue with manufacturing of an API that is an ingredient for the drug, the report said.
The FDA said that among the 20 other drugs that it has identified that solely source their APIs or finished drug products from China, none of the companies contacted have reported any shortages. “Also, these drugs are considered non-critical drugs,” the FDA said.
Yet experts believe the actual impact could be much more severe than the FDA officials deem.
“It is normal for an outbreak in China to cause a shortage of drug ingredients in the US, since almost all of the APIs’ primary products in the world are made in China,” a source in the medical resources industry told the Global Times on Monday. The person added that these products have limited technical content, but the upstream industry chain is long and the environmental pressure on production is heavy, making it very difficult to be replaced.
The medical trade volume between China and the US is relatively large, involving many products but focusing on APIs. It should involve over $100 billion in goods that the US needs for pharmaceutical production every year, Yu Mingde, honorary chairman of Chinese Pharmaceutical Enterprises Association, told the Global Times on Monday.
“In an outbreak, the production and transportation of raw materials could be affected, so could exports to the US,” Yu said. “API exports from China to the US are mostly for prescription drugs, while the proportion of over-the-counter drugs is small.”
Yu said that the association is counting the actual number of pharmaceutical raw material enterprises affected by the outbreak and no result has been unveiled yet.
Sharon Yam, sales director of Hubei Biocause Group, which sells 70 percent of its products overseas, including over 30 percent to the US, told the Global Times on Monday that there will certainly be an impact on the company’s supply chain.
“We cannot resume work till March 10 because of epidemic prevention, so the products cannot be made, the logistics are stagnant and the backlog cannot be shipped,” Yam said.
The company’s APIs are mainly for antipyretics targeting global pharmaceutical manufacturers, mainly the US and other Western markets.
Dou Yongliang, chief representative of Gyma’s China office, told the Global Times that one of its business partners in Wuhan, the worst-hit city amid the epidemic, has encountered some obstacles in conducting normal operations and even partial capacity has not resumed.
“On top of that, the logistics sector is disrupted at the moment, delaying the sending of API samples to clients in the US,” Dou noted.
Gyma is a US sourcing agent linking downstream API suppliers with upstream manufacturers of finished dosage.
“Most Chinese APIs are exported to India, where the materials will be processed to finished products, before they are exported to America,” said Dou, adding that there are also some Chinese APIs directly exported to the US.
Despite the uncertainties, experts and representatives that the Global Times reached all believed that the impact would be limited on markets outside China if the epidemic in China can be contained in April.
Yu also said that if it is a one-quarter effect, it may not have much of an impact on overseas markets.
“The effect on exports may only be temporary and I think the production and supply of APIs in China will resume in May and June, if no accident happens,” he said.
(In association with Global Times)
