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The shares of pharma companies Dr Reddy’s Laboratories and Divi’s Laboratories, both Hyderabad-based, took big hits following recent observations by the US regulator on their manufacturing units.
The Divi’s Labs scrip was down 20 per cent (19.77 per cent) on Tuesday to close at ₹634.55 on an import alert 66-40 issued by the US FDA on products manufactured at the company’s Unit-II located at Visakhapatnam.
The Divi’s Labs’ management has said that the company, along with third party consultants, is currently working to address the concerns of the US FDA and is making all efforts to fully meet the compliance requirements.
On Tuesday, Dr Reddy’s Labs’ scrip too closed down, though only 4.36 per cent at ₹2,622.80, over reports of the US FDA’s recent inspection and observations on its manufacturing plant in Duvvada near Visakhapatnam.
In a filing to the stock exchanges, the pharma major said it was preparing a comprehensive response and would submit it to the US FDA within the stipulated timeframe on the Duvvada manufacturing facility.
The company had earlier this month informed about the audit of the company’s formulation facility in Duvvada by the US regulator. The inspection was completed on March 8, 2017 and the company was issued a Form 483 with 13 observations and that it was addressing the observations made by the inspection team on their facility.
In the past few weeks, the company had been facing issues with regard to US FDA observations, which had hit the company share price.
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