Lupin gets USFDA warning For Goa And Pithampur plants
Lupin has received warning letter from the US Food And drug Administration for its Goa and Pithampur Unit 2 plant indicating a continued regulatory concerns for the Drug maker. Last week Lupin gains 1% on USFDA Approval to launch tablets in US market.
The Lupin stock fell avg. 15% in intraday Trade to Rs. 848 after the company notified the exchange about the warning letter. While the company can continue to supply existing product to the US market, fresh approval will be delayed.
The company earlier had received 3 Form 483 observations in Goa on April 7, 2017 and 6 Form 483 observations in Pithampur (Unit II) on May 19, 2017.
The company had responded to all the observations.
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“We are deeply disappointed to have received these outcome. While there will be no disruption of existing product supplies from either of these locations, there will be likely to be delay on new product approvals from these two facilities, company said in release.
We plan to address the concerns raised by the USFDA expeditiously and will work with USFDA to resolve these issues at the earliest, it added.
