The US FDA conducted an inspection at Sun Pharma’s Dahej facility from May 10 to May 17. During the inspection, the FDA issued 4 adverse observations along with Form 483.
As a result of these reports, Sun Pharmaceutical shares declined on May 30. The decline was attributed to the news of the US FDA issuing four observations to one of Sun Pharma’s manufacturing facilities.
At the time of writing, Sun Pharma shares were trading at ₹1,457 per share on the NSE, marking a 1.47% decrease compared to the previous session’s closing price. In the past year, Sun Pharma shares have risen by approximately 52%, outperforming the Nifty 50 index, which rose by 22%.
Observations made by the US FDA included inadequate precautions against API contamination and a lack of procedures for routine maintenance.
Sun Pharma also faced criticism for not documenting material sampling methods and was instructed to identify impurity reference standards before analytical standards.
The Dahej facility holds significance for Sun Pharma’s exports to the US, although specific revenue contributions are not disclosed.
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