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USFDA issues 4 adverse observations after inspection of Sun Pharma's Dahej facility

30 May 2024 , 07:50 PM

Sun Pharmaceutical shares fell on May 30 after reports surfaced that the US Food and Drug Administration (US FDA) has issued four observations to one of the company’s manufacturing facilities.According to sources, the USFDA investigated Sun Pharma’s Dahej facility from May 10 to May 17, and issued four observations along with Form 483.

According to reports, the USFDA made various observations concerning Sun Pharma. First, the company did not take appropriate safeguards to avoid API contamination. Another remark pointed to a lack of routine maintenance processes.

Furthermore, Sun Pharma neglected to document their material sampling procedures. The business was also told to identify impurity reference standards before analytical standards. The US Food and Drug Administration defines a reference-standard substance as a highly pure and well-characterized chemical.

Dahej is an important operation for Sun Pharma because it contributes significantly to the company’s exports to the United States, which is its principal market. Sun Pharma does not disclose particular revenue streams from individual units.

Sun Pharma shares have grown by almost 52% over the last year, compared to a 22% increase in the Nifty 50 index.

At around 2.25 PM, Sun Pharma was trading 1.48% lower at ₹1,457.05 per piece, against the previous close of ₹1,478.95 on NSE. The counter touched an intraday high and low of ₹1,477.40, and ₹1,452.65, respectively.

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