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“The company received a warning letter issued by the US Food and Drug Administration (USFDA) on November 6, 2017 for our formulation manufacturing facilities at Goa and Indore (Pithampur Unit II),” Lupin said in a BSE filing.
While there will be no disruption of exiting product supplies from either of these locations, there will be a delay of new product approvals from these two facilities, it added.
The company had earlier received three Form 483 observations in Goa on April 7, 2017 and six Form 483 observations in Pitthampur (Unit II) on May 19, 2017.
Lupin said it plan to address the concerns raised by the USFDA expeditiously and will work with the USFDA to resolve these issues at the earliest.
At 01:22 PM; the stock was trading 14.5% lower at Rs 885 on the BSE, as compared to 0.57% decline in the S&P BSE Sensex. The trading volumes on the counter jumped more than four-fold with a combined 9.48 million shares changed hands on the NSE and BSE so far.