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Warning given by France's medicines regulatory authority of fake GMP certificates

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 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. The US drug regulator issues an EIR upon successful completion of site inspection. 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.

According to the MD of the company, Lupin is committed to ensuring that all systems and processes followed are compliant with cGMP and are committed to bring in quality products to market. It is the goal of the company to remain well ahead on the compliance curve. 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.



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