Image Source : Business Standard
Shares of Strides Pharma Science Ltd fell up to 2.1% in early trade after the USFDA issued four procedural observations for the company’s New York based formulations plant. The company said the observations are non-critical and will not affect product supplies, assuring a timely response to the regulator.
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Key Highlights
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FDA Action: The USFDA concluded a routine inspection at Strides Pharma’s Chestnut Ridge, New York facility, issuing a Form 483 with four procedural observations.
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Company Statement: Strides termed the points as “procedural” in nature, confirming there is no impact on current supply or manufacturing operations.
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Stock Reaction: SRID.NS declined as much as 2.1% in early trade on Friday before trimming losses. The stock has been volatile after recent regulatory updates.
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Next Steps: The company said it will respond to the FDA within the prescribed timeline and remains confident of closing the observations satisfactorily.
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Broader Context: Such inspections are part of routine cGMP compliance checks conducted by the USFDA on global pharmaceutical facilities supplying the US market.
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Market takeaway: While the immediate sentiment turned cautious, analysts expect limited long-term impact if Strides resolves the observations quickly.
Sources: CNBC TV18, Business Standard, Indian Pharma Post, Medical Dialogues
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