Sun Pharmaceutical shares were trading in red on May 30 after reports suggested that the US Food & Drug Administration (US FDA) issued four observations to one of the pharma major's manufacturing facilities.
According to CNBC-TV18, the US FDA inspected Sun Pharma's Dahej facility between May 10 - May 17, following which it issued four observations along with the Form 483.
At 1.30 pm, Sun Pharma shares were quoting at Rs 1,459.4 apiece, lower by 1.3 percent on the NSE as compared to the previous session's closing price.
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According to reports, USFDA made several observations about Sun Pharma. First, the firm didn't take adequate precautions to prevent API contamination. Another observation highlighted the lack of procedures for routine maintenance.
Additionally, Sun Pharma failed to document their material sampling methods. The company was also instructed to identify impurity reference standards before analytical standards. According to the USFDA, a reference-standard material must be a highly purified and well-characterized compound.
Dahej is a key unit for Sun Pharma, as it significantly contributes to its exports to the US, a primary market for the company. Sun Pharma does not reveal the specific revenue contributions of individual units.
Over the past year, Sun Pharma shares have risen around 52 percent as against a 22 percent rise in the Nifty 50 index.
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