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The warning letter summarizes violations with respect to current good manufacturing practice (cGMP) regulations.
The contents of the warning letter will be made public by the USFDA in due course, said the firm.
Earlier on 11 April 2024, the company said that the USFDA had conducted an inspection at its Dadra facility from 4 December 2023 to 15 December 2023. US FDA had subsequently determined that the inspection classification status of this facility as official action indicated (OAI), it added.
Sun Pharmaceuticals Industries is a leading global pharmaceutical company with specialty and generic presence and India's top pharma company.
The pharma major’s consolidated net profit jumped 33.77% to Rs 2,654.58 crore in Q4 FY24 as against Rs 1,984.47 crore posted in Q4 FY23. Revenue from operations grew by 10.14% to Rs 11,813.33 crore in Q4 FY24 as against Rs 10,725.57 crore recorded in Q4 FY23.
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