Dr. Reddy’s Hyderabad plant handed 10 US FDA observations
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This was a routine cGMP inspection at our formulations manufacturing facility (FTO-3) in Hyderabad.
The company said that the observations will be addressed within the stipulated timeline.
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Indian pharma major Dr. Reddy’s said that its manufacturing plant in Bachupally, Hyderabad was inspected by the United States Food & Drug Administration (US FDA) from October 19, 2023, to October 27, 2023.
As a result, the plant received a Form 483 with ten observations. The inspection was a routine cGMP inspection at the company’s formulations manufacturing facility (FTO-3) in Hyderabad. Dr. Reddy’s stated that it will address the observations within the stipulated timeline.
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Dr. Reddy’s announced on October 27 that it achieved its highest-ever consolidated net profit of Rs 1,480 crore in the July-September quarter, which is a 33 percent increase from the same period last year when it reported a profit of Rs 1,112.80 crore.
In the second quarter, the company’s North America business generated a revenue of Rs. 3170 crore, showing a YoY growth of 13 percent, although it experienced a QoQ decline of 1 percent. The growth was due to a rise in momentum in its core portfolio, Mayne integration, favorable foreign exchange, which was partially offset by price erosion.
As of 10:02 am, shares of the company are trading down 1.64 percent on NSE at Rs. 5,308.80.
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