Sun Pharma received the EIR or Establishment Inspection Report from the US Food and Drug Administration (FDA) for its Halol facility in Gujarat. The American regulator had conducted inspection at Sun Pharmaceutical Industries’ facility in Halol from February 12 to February 23, 2018.
In December 2015, the US regulator had issued a warning letter to Sun Pharma indicating dissatisfaction with the remedial measures the company had implemented. The US FDA concluded that the issues contained in the warning letter issued in December 2015 have been addressed. Sun Pharma will now be able to restart supplies to its largest market, the US, from the Halol facility. US market contributed around 15 per cent to the company’s US revenue.