Updated on 12 August 2013
After Tata Aeronautics Limited started part production in Mihan a few months ago, Lupin will become the second unit there to become partly operational.
Mumbai: Indian drug giant Lupin Pharma has begun trial run at Mihan that it expects to become fully functional in two years. The Nagpur unit will export drugs to US.
After Tata Aeronautics Limited (TAL) started part production in Mihan a few months ago, Lupin will become the second unit there to become partly operational.
"We have now begun commissioning of the unit. We have the exhibit batch of the products developed by our research and development (R&D) wing. It will take six months for their stability test and then we will apply for a license from United States (US) food and drugs administration (FDA)," said Mr KR Gupta, director, corporate affairs, Lupin.
He added that the products that Lupin intends to manufacture at the Mihan unit have been successfully tested in the company's research laboratory, but US FDA norms require them to be tested commercially.
"After we apply for US FDA license the officials will inspect the Mihan plant. They will give us two permits - unit permit and product permit. Then they give the clearance. It will take two years for completing all the formalities. This much time is required for all units that manufacture products for US," he explained.