LoginRegister

    Sun Pharma gets clearance for Halol plant from USFDA

    Written by Ruby Khatun Khatun   |  
    Sun Pharma gets clearance for Halol plant from USFDA

    Mumbai: Supply restrictions imposed on India’s largest drugmaker Sun Pharmaceutical Industries by U.S. regulators have been lifted, the company said on Tuesday, removing a major drag on its share price.


    Sun will now be able to resume shipments of drugs made at its Halol factory in western India, which contributed as much as 15 percent to its U.S. revenue in 2015. The restrictions on some drugs made at the site had been imposed after an inspection revealed quality control failures.


    The world’s fifth-largest generic drugs maker has been working on fixing problems identified by the U.S. Food and Drug Administration (FDA) and the agency conducted another inspection in February.


    “The agency concluded that the inspection is now closed and the issues contained in the warning letter issued in December 2015 have been addressed,” Sun said in a statement.








    The clearance could add as much as $100 million to the company’s 2019 revenue as it ramps up volumes, said Praful Bohra, a pharmaceuticals analyst at Religare Capital Markets.


    Halol is one of Sun’s most important sites because it also has the technical capabilities to make the complex niche drugs the company is developing to counter increasing competition in the United States.




    The company said last month that it plans to launch three new drugs this year and is considering cutting down on spending on some generic drug projects that have become unviable.




    (Reporting by Zeba Siddiqui in Mumbai; Editing by Jason Neely and David Goodman)









    clearancedrugsfailuresgeneric drugHalol plantinspectionliftedPraful Bohraquality controlrestrictionsShasun PharmaceuticalsshipmentsSun PharmaU.S. Food and Drug AdministrationUSFDAwarning letter
    Source : REUTERS

    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

    Ruby Khatun Khatun
    Ruby Khatun Khatun
      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND
      Medical Dialogues is health news portal designed to update medical and healthcare professionals but does not limit/block other interested parties from accessing our general health content. The health content on Medical Dialogues and its subdomains is created and/or edited by our expert team, that includes doctors, healthcare researchers and scientific writers, who review all medical information to keep them in line with the latest evidence-based medical information and accepted health guidelines by established medical organisations of the world.

      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. You can check out disclaimers here. © 2025 Minerva Medical Treatment Pvt Ltd

      © 2025 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      X