FDA Clears Lupin India Plant

Nov 06, 2016

Live Mint

The U.S. FDA has officially cleared Mumbai-based Lupin’s Goa manufacturing plant of cGMP violations observed during a March 2016 inspection.

During the inspection in March, the agency had made nine observations relating to cGMP deviations.

Lupin announced that it has received an Establishment Inspection Report (EIR) from the FDA, indicating closure of all FDA inspections at the facility.

Lupin has 30 Abbreviated New Drug Applications (ANDAs) pending from this location.

Read the Live Mint coverage


Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.


No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments