Ipca Laboratories has been banned by the United States Food and Drug Administration (FDA) from selling drugs in the US from its plant in Ratlam Madhya Pradesh due to violations of standard production practices.
Ipca had voluntarily halted shipments to the US from the plant in July 2014 after the FDA outlined half a dozen violations including data integrity issues.
The US drug regulator announced the ban, called import alert, in a notice on its website late on Thursday. It did not elaborate.
Over the past year, large home-grown drug firms such as Ranbaxy Laboratories and Wockhardt have been hit by a spate of regulatory sanctions due to concerns about production processes at their local plants.
Ipca shares were trading at Rs 672.40 a piece, down 3.8 per cent in morning trade on Friday, while the Nifty was up 1.1 per cent.