US FDA classifies observations for Lupin’s API unit at Madhya Pradesh

NEW DELHI: The US Food and Drug Administration (FDA) has classified violations it observed at Lupin’s manufacturing unit at Mandideep in Madhya Pradesh as non-serious. The unit manufactures active pharmaceutical ingredient (API), which are key raw materials for medicines.

The classification of observations as voluntary action indicated (VAI) in an establishment inspection report (EIR) for the unit virtually signals a clearance for it.

“We are pleased to have received the EIR for our Mandideep Unit II facility, our important cardiovascular API manufacturing facility. We remain committed to enhancing compliance and quality standards across all our manufacturing sites,” Lupin managing director Nilesh Gupta was quoted as saying in a release.

The inspection was carried out by the US regulator between November 26 and December 4, after which it had issued an EIR.

The regulator issues EIRs to manufacturing units when it considers violations of good manufacturing practices as not being serious in nature and clears the plant for export of drugs to the US.

This is the third EIR Lupin has received in April so far, having received clearances for its plants at Aurangabad and Nagpur in Maharashtra earlier.

Lupin’s other API manufacturing unit at Mandideep in Madhya Pradesh had received a warning letter in September for repeated violations at its plant. The warning letter was issued for lack of hygiene and written procedures and failure to investigate unexplained discrepancy in batches.

Lupin’s plants at Goa and Pithampur in Madhya Pradesh are under warning letters since 2017.