Mumbai: The US drug regulatory agency, the Food and Drugs Administration (FDA), has warned Sun Pharma, India's biggest drug-manufacturing company, for lapses it observed at its key facility in Halol during an inspection in September 2014, the company said today.
The US FDA inspection had found pointed to about 23 serious issues which stood in violation to the standard manufacturing norms.
The move gathers importance for a slew of factors. The manufacturing unit in Halol is among Sun Pharma's largest. It is used for producing multiple formulations, including injectables, which are mainly exported to US, its largest market.
The FDA action have hindered the company's efforts to ramp up its US sales at the rates seen earlier and has led to lower FY16 earnings estimates.
The stock too trades almost 35 percent lower (CMP Rs 790) compared to its peaks of Rs 1,200 in April 2015.
Warning letters, such as the one sent to the pharma giant, are issued for violations of regulatory significance and could lead to enforcement action such as import alerts, if not promptly and adequately corrected in compliance with US regulations.
The Halol site has been a primary contributor to Sun's revenues from the US. Prior to the US FDA's objections raised last year, analysts estimate Halol facility had accounted for about 10 per cent or $440 million of Sun's global revenues of $4.3 billion.
Over the last few months, it has declined to around $240 million post the FDA audits.
