Mumbai-based Lupin Pharmaceuticals has been hauled up by the U.S. FDA on a manufacturing operation, this time at its Goa plant for failure to meet 9 areas of operating standards.
|Lupin's Nilesh Gupta|
The warning comes in the same month Lupin completed a purchase of privately held U.S.-based GAVIS Pharmaceuticals to expand its manufacturing footprint in the U.S.
The inspection of the Goa plant happened last week, Lupin said in a notice to the Bombay Stock Exchange, and the company is working up a reply.
"We wish to state that the U.S. FDA inspected company's Goa facility last week and cited nine observations," Lupin said in the stock exchange note.
"We are in midst of putting together a response to address the FDA's observations."
In February, Lupin Managing Director Nilesh Gupta told the Business Standard newspaper that the company's expansion plans include a deeper foray into Japan with the addition of a plant there and another plant in Goa, India, to work directly with the Japanese market.
In 2011 Lupin made an acquisition in Japan, buying Tokyo-based I'rom Pharmaceutical. In 2007 it bought Kyowa Pharmaceutical Industry.
Lupin's current Goa plant, the Economic Times said, supplies over 100 products to various regulated markets.