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Drugmaker Lupin has received a warning letter from the US Food and Drug Administration on its finished medicines plants in Goa and Indore.
“We had earlier three Form 483 observations in Goa on April 7, 2017, and six 483 observations in Pithampur (Unit II, Indore) on May 19, 2017. We responded to all observations,” the company told the Bombay Stock Exchange, expressing its disappointment at the outcome.
The development sent the company’s stock price into a tailspin, closing 17 per cent lower at ₹860.50 on the BSE on Tuesday.
“While there will be no disruption of existing product supplies from either of the locations, there will likely be a delay of new product approvals from these two facilities,” the company said.
A form 483 involves regulatory observations made following an inspection.
A company is given time to respond and depending on whether this was to the regulator’s satisfaction or not, the matter escalates to a warning letter.
Ranjit Kapadia, Senior Vice-President with Centrum Broking, feels that it will take at least six months for the issue to take a direction of some sort. The company will have to take aggressive remedial measures to get matters under control, says Kapadia.
Sarabjit Kour Nangra, Angel Broking’s VP Research — Pharma, points out that these Lupin plants together contributed more than half of the drugmaker’s US sales and approximately 20 percent of its total sales.
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