Suppliers Plan for Chloroquine Capacity

Following reports that hydroxychloroquine and chloroquine are under evaluation in clinical trials as a potential treatment of COVID-19, drug companies are donating doses and planning for ramping up supply. 

Bayer announced in a March 19, 2020 press release that it will donate 3 million tablets of the drug Resochin (chloroquine phosphate). It is currently not approved for use in the United States, but Bayer said it is working with appropriate agencies on an Emergency Use Authorization for the drug’s use in the US.

Novartis announced in a March 20, 2020 press release that it will donate up to 130 million doses of generic hydroxychloroquine and that it is supporting ongoing clinical trials. The company also noted in the release that it would aim to ensure that patients currently depending on this medicine are not impacted by the donation, and that it is exploring scaling of capacity to increase supply. Novartis Sandoz division currently only holds a registration for hydroxychloroquine in the US, and it will pursue appropriate regulatory authorizations from FDA and the European Medicines Agency, the company reported.

Mylan said in a March 19, 2020 press release that it has restarted production of hydroxychloroquine sulfate tablets at its West Virginia manufacturing facility in the US to meet the potential for increased demand resulting from potential effectiveness of the product in treating COVID-19. Mylan’s drug is approved by FDA for the treatment of malaria, lupus erythematosus, and rheumatoid arthritis. The company said it is also taking steps to initiate production of this product outside the US in the coming weeks. The press release noted that Mylan expects to be in a position to begin supplying product by mid-April, and with currently available API, will be able to ramp up manufacturing to provide 50 million tablets.

Teva said in a March 20, 2020 press release that it would donate more than six million doses of hydroxychloroquine sulfate tablets, which are approved by FDA for malaria, lupus erythematosus, and rheumatoid arthritis, to US hospitals as an investigational target to treat COVID-19. “Additional production of hydroxychloroquine sulfate tablets is also being assessed and subsequently ramped up with materials that are being sent to Teva from our ingredient supplier. Teva will ship six million tablets through wholesalers to hospitals by March 31, and more than 10 million within a month,” the company said in the press release. 

FDA noted in a March 19, 2020 press release that it would ensure the drug would remain available for patients who take it to treat severe and life-threatening illnesses, such as lupus. While cautioning that first the efficacy of the drug in treating COVID-19 must be ensured, FDA Commissioner Stephen Hahn, MD, said in the press release, “At the same time, we will engage with domestic manufacturers to ramp up production of this product to mitigate any potential supply chain pressures. If clinical data suggests this product may be promising in treating COVID-19, we know there will be increased demand for it.”

Sources: FDA, Novartis, Bayer, Mylan, Teva