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    • Laurus Labs gets...

    Laurus Labs gets tentative USFDA approval for HIV combo drug

    Farhat NasimWritten by Farhat Nasim Published On 2019-02-04T09:30:58+05:30  |  Updated On 16 Aug 2021 4:17 PM IST

    Hyderabad: Indian pharmaceutical player, Laurus Labs said Sunday it has received tentative approval from the United States Food and Drug Administration for TLD, which is one of a preferred first-line regimen for the treatment of HIV. The approval for Tenofovir/Lamivudine/Dolutegravir (TLD) 300/300/50mg fixed-dose combination (FDC) was given under the US President's Emergency Plan for AIDS Relief, the company said in a release.


    The TLD will be available in the generic form in low and middle-income countries, it said.


    The drug will be manufactured from the company's Unit 2 located at APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.


    Read Also: Laurus Labs gets USFDA approval for diabetes drug


    Commenting on the USFDA approval, Laurus Labs CEO Satyanarayana Chava said, "It is a significant approval for Laurus Labs which has forayed into finished dosage forms recently. This product would demonstrate the company's capability to develop fixed-dose combinations of ARVs (antiretroviral).


    Laurus Labs has also received an Establishment Inspection Report from the USFDA for its Unit 6 located at APSEZ, Atchutapuram, on February 2, it said.


    The Company is one of the manufacturers of Active Pharmaceutical Ingredients (APIs) for anti-retroviral (ARV) and Hepatitis C. Laurus also manufactures APIs in Oncology and other therapeutic areas. Laurus Labs also forayed into Finished Dosages Forms capabilities on the back of existing strengths in APIs.

    AIDSAndhra PradeshAPSEZAPSEZ AtchutapuramEstablishment Inspection ReportHIVHIV drugHyderabadLaurus LabsSatyanarayana ChavatreatmentUnited States Food and Drug AdministrationUSFDA
    Source : With input

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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