India's Lupin announced it has received nine observations relating to inadequacy and adherence to operating norms for its manufacturing plant in Goa from the U.S. FDA.
Lupin noted that the observations are on aspects such as inadequacy and adherence to standard operating procedures. FDA observations are made when in the investigator’s judgement, conditions or practices observed would indicate that any drug or device has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated.
The Goa facility supplies over 100 products to several regulated markets, including the U.S. and EU.
Following the announcement, Lupin stock fell on speculation that key investor Rakesh Jhunjhunwala is selling some of his 7.42 million Lupin shares.
Read the ET article