Lupin receives nine observations from USFDA for Goa plant
New Delhi : Drug major Lupin said it has received nine observations relating to inadequacy and adherence to operating norms for its manufacturing plant in Goa from the US Food and Drug Administration (USFDA).
"We wish to state that the USFDA inspected company's Goa facility last week and cited nine observations," Lupin said in a regulatory filing.
The observations are on aspects such as inadequacy and adherence to standard operating procedures (SOPs), it added.
"We are in midst of putting together a response to address the FDA's observations," the Mumbai-based company said.
The company's Goa facility supplies over 100 products to various regulated markets including the US and EU. The plant has filed more than 115 abbreviated new drug applications (ANDA's) in the US market.
Lupin has also filed for ANDAs for markets like the EU, Japan and Brazil from the facility.
Lupin stock was trading 7.31 per cent down at Rs 1,731.95 during the afternoon session on BSE.
"We wish to state that the USFDA inspected company's Goa facility last week and cited nine observations," Lupin said in a regulatory filing.
The observations are on aspects such as inadequacy and adherence to standard operating procedures (SOPs), it added.
"We are in midst of putting together a response to address the FDA's observations," the Mumbai-based company said.
The company's Goa facility supplies over 100 products to various regulated markets including the US and EU. The plant has filed more than 115 abbreviated new drug applications (ANDA's) in the US market.
Lupin has also filed for ANDAs for markets like the EU, Japan and Brazil from the facility.
Lupin stock was trading 7.31 per cent down at Rs 1,731.95 during the afternoon session on BSE.
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