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    • Laurus Labs gets USFDA...

    Laurus Labs gets USFDA Establishment Inspection Report for Visakhapatnam units

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-09-06T13:03:45+05:30  |  Updated On 16 Aug 2021 3:39 PM IST

    The establishment inspection report (EIR) from US Food and Drug Administration (USFDA) is for company's active pharmaceutical ingredients units 1 and 3, at Visakhapatnam, for the inspection conducted on June 2019, Laurus Labs said in a filing to BSE.


    New Delhi: Drug firm Laurus Labs on Thursday said it has received an establishment inspection report from the US health regulator for two of its active pharmaceutical ingredients units at Visakhapatnam in Andhra Pradesh.


    The establishment inspection report (EIR) from US Food and Drug Administration (USFDA) is for company's active pharmaceutical ingredients units 1 and 3, at Visakhapatnam, for the inspection conducted on June 2019, Laurus Labs said in a filing to BSE.


    The company has also received approval from the Global Fund (GF) expert review panel for its fixed-dose combination, TLE 400, for supply in GF-funded projects, it added.


    Read Also: Laurus Labs, Rising Pharma launches neuropathic pain capsules in the US


    Laurus Labs is one among the three companies to receive the approval for this product in antiretroviral therapy, the company said.


    TLE 400 is the alternative first-line regimen for treatment of HIV/AIDS as per the World Health Organization guidelines issued in July 2019, it added.


    Read Also: USFDA completes inspection at Laurus Labs' AP unit

    AIDSEIREstablishment Inspection Reportglobal fundHIVLaurusLaurus Labspharmapharma companypharma newspharma news indiaUS Food and Drug AdministrationUS health regulatorUSFDAUSFDA inspectionUSFDA observationsVisakhapatnamWHOWorld Health Organization
    Source : PTI

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    Medical Dialogues Bureau
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      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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