FDA lifts import alert on Ipca Labs for chloroquine supply

24-Mar-2020 - Last updated on 24-Mar-2020 at 16:15 GMT

(Image: Getty/Oleksii Liskonih)

In order to boost the supply of chloroquine, the US FDA has allowed Ipca to supply APIs and finished product to the country.

After hydroxychloroquine and chloroquine were spoken about by President Trump as a potential treatment for the novel coronavirus, supply of the products and its active pharmaceutical ingredient (API) has become a major talking point.

Over the last week, a number of manufacturers of the product have come forward offering donations of supplies and announced expansions to their manufacturing capacity.

Despite this, the US Food and Drug Administration (FDA) has taken an additional step to secure supplies for a treatment that is also used to treat malaria, arthritis and lupus.

Ipca Laboratories announced that on Friday of last week, the FDA had emailed the company to inform it that an exception would be made to the import alert previously placed upon its supply to the US.

The updated status now allows the company to export hydroxychloroquine sulphate and chloroquine phosphate APIs, produced at its Ratlam, India, site; the company will also be able to export hydroxychloroquine sulphate tablets produced at its Pithampur site.

However, the situation may only be temporary, with Ipca stating, “FDA has also informed that their exception will be re-considered if the shortage implications change.”

As yet, it has not been confirmed that chloroquine products are effective at treating COVID-19 – clinical trials assessing the efficacy of the treatment are still ongoing.