New Delhi: With the novel coronavirus infections spreading at an alarming pace in the US, the country’s Food and Drug Administration (FDA) has partially lifted an import alert on Ipca Laboratories’ two plants to ensure supply of chloroquine tablets.
The medicine is considered one of the possible treatments for the infection, officially called Covid-19, by the US Centre for Disease Control (CDC).
The US FDA has allowed the import of active pharmaceutical ingredients (APIs) of hydroxychloroquine sulphate and chloroquine phosphate produced at the company’s APl manufacturing unit situated at Ratlam in Madhya Pradesh.
The regulator has also allowed import of hydroxychloroquine sulphate tablets produced at the formulations manufacturing units at Indore special economic zone and Pithampur in Madhya Pradesh, and Silvassa, Ipca Laboratories said in an exchange filing.
“US FDA has also informed that their exception will be re-considered if the shortage implications change,” Ipca Laboratories said.
Ipca Laboratories’ plants are under the US regulator’s import alert for more than three years for multiple violation of good manufacturing practices.
However, with the coronavirus infections spreading at an alarming pace in world’s largest economy, the US regulator has been forced to partially reconsider its ban.
There are nearly 20,000 people in the US who have been infected by the novel virus, with more than 100 of them dying.
Since the pandemic started in China in December, there are now more than 286,000 infected globally, with the death toll nearly 12,000, according to John Hopkins University’s live tracker for the disease.