India's second largest drug maker by market value Lupin Ltd. has announced that it has got an all clear from the United States Food and Drug Administration(USFDA). This comes after the U.S. pharma watchdog inspected its Goa plant in March 2016.
The drug regulatory agency has issued an establishment inspection report, Lupin said in a media statement. With this, all outstanding USFDA inspections at Lupin's Goa facility have been completed.
An establishment inspection report is issued by the USFDA which details the inspectional findings after completion.
We are committed to ensuring that all systems and processes followed by Lupin are compliant with cGMP and are committed to bringing quality products to market. We are grateful for the USFDA’s confidence in our corrective action plan and in our team. It is our goal to remain well ahead on the compliance curveVinita Gupta, CEO, Lupin and Nilesh Gupta, MD, Lupin