Laurus Labs Limited has been issued the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its active pharmaceutical ingredient (API) facility in Visakhapatnam, Andhra Pradesh. This achievement reaffirms the focus of the company on regulatory compliance as well as pharmaceutical manufacturing standards of quality.
Key Points:
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USFDA Approval: The EIR validates that Laurus Labs' API plant complies with USFDA regulatory standards, paving the way for further exports to the U.S. market.
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Facility Details: The inspection was at Unit-5, Parawada, from October 24-28, 2024, endorsing the company's compliance with Good Manufacturing Practices (GMP).
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Market Impact: Post announcement, Laurus Labs' stock increased by 8%, its steepest intraday advance since January 30, 2025.
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Strategic Growth: The firm continues to concentrate on growth in its human health and animal health CDMO segments, with a robust pipeline anticipated in FY26.
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Operational Resilience: In spite of a fire accident at one of its API blocks in December 2024, Laurus Labs maintained business continuity, with operations in other units unaffected.
This success reinforces Laurus Labs' position in the global pharma industry, underlining its quality and regulatory excellence commitment.
Source: CNBC TV18, Express Pharma, Business Standard