The largest drug maker of India, Sun Pharma has stopped production and shipment at its Punjab-based Mohali facility to the US market. However the halt is temporary and in line with corrective actions guided by the US healthcare regulator FDA.
The company in its regulatory filing on Sunday said that, “These actions include, among others, retaining an independent CGMP expert to conduct batch certifications of drugs manufactured at the Mohali facility.”
It added that the company is taking required measures and corrective steps but there will be a temporary pause in the release of batches from Mohali until US FDA-mandated measures are implemented.
Sun Pharma’s Mohali plant came under US FDA radar in august last year where it carried inspection from August 3rd to August 12th, 2022. The inspection was classified as “Official Action Indicated’ (OAI).
That time, the FDA had issued a Form-483, with 6 observations. Sun Pharma said, it remains committed to work closely with the US FDA and continues to enhance its compliance on an ongoing basis.
On Monday, at 10.12 AM, Sun Pharma is the top loser on Nifty with trading at Rs 968.25 per share down by 2.14% from the previous close of Rs 989.45 on NSE.
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