Lupin said the US drug regulator issued the same after concluding its inspection, which was conducted from April 13 to April 17, 2026.
“We will address the observations and respond to the USFDA within the stipulated timeframe. We are committed to be compliant with CGMP standards across all our facilities,” Lupin said in an exchange filing.
On another note, last week, Lupin announced the launch of dapagliflozin tablets in the 5mg and 10mg strengths in the US. The launch was post the USFDA approved its abbreviated new drug application (ANDA).
Earlier this month, Lupin said its wholly-owned subsidiary Nanomi BV, the Netherlands, is set to acquire the minority shareholding of its arm Multicare Pharmaceuticals Philippines Inc (MPPI).
It said Nanomi inked the definitive agreements to acquire the minority shareholding from certain existing shareholders of MPPI to acquire 1.1 crore shares, or 43.38% of its total outstanding paid up shares.
Lupin shares ended the previous trading session 0.2% lower at ₹2,322.5 apiece. The stock has risen 10.5% this year, so far.
