Mumbai: The US Food and Drug Administration (US FDA) has cleared Lupin Ltd’s Goa manufacturing plant of violations of good manufacturing practices (cGMP) observed during an inspection in March 2016.
The development comes as a major relief to the company, India’s third largest pharmaceutical firm, as its Goa unit accounts for about 30-40% of its sales in the US. The facility manufactures a range of finished products, including oral solids and injectables.
The company has received an Establishment Inspection Report (EIR) from the US drug regulator for its Goa unit, indicating closure of all US FDA inspections at the facility, Lupin said in an exchange filing.
“We are committed to ensuring that all systems and processes followed by Lupin are compliant with cGMP and are committed to bring in quality products to market. It is our goal to remain well ahead on the compliance curve," managing director Nilesh Gupta was quoted as saying in the filing.
The US drug regulator issues an EIR upon successful completion of site inspection.
During the inspection in March, the US FDA had made nine observations relating to deviations from cGMP at the Goa facility.
“The receipt of EIR is a positive development for Lupin. It indicates that the US FDA found the company’s remedial measures in order. The tentative product approvals, which were pending due to regulatory issues at Goa plant, will now get final approval," Ranjit Kapadia, senior vice president at Centrum Broking, said.
The US is the biggest market for the company, accounting for 43% of the total sales of Rs13,702 crore in 2015-16.