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Laurus Generics Inc., a subsidiary of Laurus Labs, received a Form 483 from the US FDA following a post-marketing inspection. Shares of Laurus Labs Ltd fell by 0.94%, closing at ₹571.45.
Laurus Labs Ltd announced that its wholly-owned subsidiary, Laurus Generics Inc. (LGI), based in Berkeley Heights, New Jersey, USA, has received a Form 483 from the US Food and Drug Administration (FDA). The Form 483, issued after a four-day post-marketing adverse drug experience (PADE) inspection from 13th to 21st January 2025, identified one observation regarding compliance practices. The company plans to address the observation within the stipulated timelines.
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Inspection Duration: Conducted over four days (13th–21st January 2025).
Inspection Focus: PADE compliance practices for Laurus Labs’ marketed products.
Observation: One observation highlighted in Form 483.
Next Steps: Laurus Labs has 15 days to respond to the US FDA.
Impact on Shares: Laurus Labs Ltd share price dropped by 0.94% on the BSE.
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The inspection scrutinised Laurus Generics Inc.’s adherence to US FDA standards for reporting adverse drug experiences. A Form 483 outlines areas of non-compliance observed during such inspections but does not indicate a final FDA determination. Companies are required to submit corrective action plans to the FDA within 15 days to address identified issues.
Aspect | Details |
Facility Inspected | Laurus Generics Inc., New Jersey, USA |
Inspection Type | Post-Marketing Adverse Drug Experience |
Duration of Inspection | 13th–21st January 2025 |
Form 483 Observations | One observation |
Response Deadline | 15 days from issuance |
Following the announcement, Laurus Labs Ltd share price closed at ₹571.45 on the BSE, reflecting a 0.94% dip. The share price movement indicates cautious investor sentiment as the company works to resolve the compliance issue.
While the issuance of a Form 483 marks a critical regulatory step, Laurus Labs Ltd remains committed to addressing the US FDA’s observation. The company’s timely response and corrective actions will be pivotal in ensuring compliance and maintaining global standards.
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