Lupin's ordeal with USFDA observations continues, shares slump over 10%

Anticipated increase in remediation and compliance costs, and possible delay in drug launches is pushing analysts to cut their forward estimates

Shares of Lupin have lost more than 10 per cent since September highs and are now trading near multi-year lows. Even though the news of its Mandideep facility receiving good manufacturing practice certificate from the Japanese drug regulator may provide some respite, the company’s ordeal with the US Food and Drug Administration (FDA) continues. This overhang is likely to keep any upsides in the stock under check.

Lupin’s Mandideep facility, which had received the Official Action Indicated (OAI) status in March 2019 from the US drug regulator, recently received a warning letter, indicating the product or process is in violation