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The Lupin shares crashed over 17% to trade at Rs 851 soon after it announced, in a stock filing, that it has received a warning letter issued by the USFDA pertaining to its plants located in Goa ...
According to analysts, this resolution could help Lupin address stagnating US revenues of around $170-200 million per quarter. They believed FDA scrutiny on its Goa and Pithampur plants were key ...
Managing director Nilesh Gupta said Lupin had received notification that the inspection carried out by the US FDA in March 2016 at its Goa facility was now closed and that the agency had issued an ...
Lupin clarifies on news item, "Lupin's Goa plant receives adverse FDA observations". * Lupin clarifies that USFDA issued form 483 citing 3 observations Source text: Further company coverage ...
Problems at Lupin’s plant in Goa, India, hit the drugmaker’s latest earnings with a double whammy, undercutting its U.S. sales while raising costs to deal with remediation efforts there.
New Delhi, Feb 8 (PTI) Drug firm Lupin on Friday said the US health regulator has completed inspection of its Goa facility and made two key observations. In a BSE filing, Lupin said ...
Lupin on Monday said it had received approval ... The approval is a significant development for the company’s Goa plant, the filing added.
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 ...
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The company said it has received a notification in this respect. The USFDA, which inspected Lupin’s Goa plant in July, 2015, had made nine Form 483 observations related to inadequacies and ...
USFDA had conducted a site inspection of Lupin’s Goa plant between January 28 and February 8 and the inspection was classified as “official action indicated (OAI)”. Lupin has in turn announc ...
The FDA is in the next few months expected to clear Lupin's Goa plant, which supplies around a third of its U.S. sales, of problems found in 2015, Desai said. However, the agency also published a ...
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