The US Food and Drug Administration has issued six observations in its latest inspection at Lupin Ltds. Pithampur facility, the company informed the exchanges today.
According to the company, three of the observations were made on Active Pharmaceutical Ingredients and on finished products.
"The inspection closed with three observations each on the API and Finished Product side. We are addressing the observations comprehensively and will respond to the US FDA within the stipulated timeframe", the company told the exchanges.
The inspection was conducted from Sept. 16-27, where the US regulator made these observations on unit one of the plant.
On Friday, shares of Lupin Ltd. closed 1.6% higher at Rs.2,222.20 on the National Stock Exchange.
(With text inputs from PTI.)
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