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US FDA gives a clean chit to Lupin's Mandideep facility
CNBC-TV18 learns that Mumbai-based drug firm Lupin Pharmaceutical’s Mandideep facility has received a clearance from the United States Food and Drug Administration (US FDA) on the warning letter issued in May 2009 to its Mandideep site. However, the company’s management declined to comment on the development.
CNBC-TV18 learns that Mumbai-based drug firm Lupin Pharmaceutical 's Mandideep facility has received a clearance from the United States Food and Drug Administration (US FDA) on the warning letter issued in May 2009 to its Mandideep site.
After receiving the letter the compnay made "significant enhancements and took appropriate corrective actions," it said in a statement to the Bombay Stock Exchange.
"With the recent inspections and satisfactory resolution of all pending concerns at Mandideep, all our facilities have now been inspected in the past year and have found to be in good shape," Executive Director Nilesh Gupta said in the statement.
Earlier, in June 2009, the company's Group President and CEO, Vineeta Gupta, had had told CNBC-TV18 that the US FDA had become vigilant in investigations and inspections of facilities under pressure from the US government. She said that the company had met US FDA officials on issues concerning its Mandideep manufacturing plant and added that the company had put all corrective measures in place at Mandideep.
The warning letter had no impact on the company's revenues emanating from Mandideep, its Chief Financial Officer, S Ramesh had said in an exclusive interview with CNBC-TV18 in November. "There has been absolutely no impact on our revenue coming in from Mandideep. We do expect a re-order to take place sooner or later. The warning letter would also be revoked."
