China APIs flow but India ban hinders U.S. approval of hydroxychloroquine

The production of Chinese active pharmaceutical ingredients (APIs) slipped by 10% to 20% during the early days of the COVID-19 outbreak in China but is quickly recovering. The bottleneck in the global supply chain for APIs is now shipping, particularly ocean freight.

This is the assessment of Chinese officials who held a press conference Tuesday. China is focusing its production efforts on APIs that are in highest demand, Xin Guobin, deputy minister of industry and information technology, said, according to a translated transcript of the Chinese language press conference. That includes chloroquine phosphate, which the FDA this week approved for use against COVID-19 based on anecdotal reports of its effectiveness.

Xin said production is stable at the two primary producers of chloroquine phosphate, and efforts are being focused on meeting international demand. One of those producers, Chongqing Kangle Pharmaceuticals, was able to export 4.9 tons of the API within five days, Xin said.
“We can further increase the supply in accordance with international market demand,” Xin said.

The story is different in India, perhaps the biggest producer of the chloroquine phosphate API. India last week added it to a list of more than two dozen APIs that it no longer is allowing to be exported while officials get a handle on how much will be needed for India’s COVID-19 outbreak.
India is in the beginning of a 21-day lockdown ordered by Prime Minister Narendra Modi. So far, the official count of COVID-19 cases in India is only 1,251 cases compared to 164,179 in the U.S. as of March 30. But that number is expected to skyrocket in the world’s second most populous country with about 1.4 billion people.
Trump administration officials are reportedly asking India to lift the ban on the APIs, NBC news reports, citing unnamed sources.

This comes after the FDA Tuesday approved emergency use of hydroxychloroquine, a drug already approved to treat malaria, lupus and rheumatoid arthritis. The approval came at the urging of President Donald Trump. Some small studies have suggested it can help some patients with COVID-19, but clinical trials, which experts say are essential to know its effectiveness, are just now getting underway.

That hasn’t deterred the Department of Health and Human Services from accepting 30 million donated doses from Novartis’ Sandoz unit, as well as another 1 million tablets of chloroquine phosphate, the other form of the drug. Bayer, Mylan and Amneal have each pledged donations or increased production of the drugs.

While countries try to sort out their API supplies, drugmakers and shippers are sorting out how to get them moved around the world. China’s Xin said he understands “main constraints to Chinese exports are sea freight, international shipping,” which has been hampered in the face of the outbreak, leading to much higher prices.

Finished pharmaceuticals can be shipped by air freight, but the number of flights in and out of China has fallen significantly as countries set up border restrictions, forcing drugmakers to scramble for slots to ship their products.

https://www.fiercepharma.com/manufacturing/chinese-apis-flowing-but-indian-ban-hinders-u-s-approval-hydroxychloroquine