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    New USFDA warning letters show Glenmark, Lupin, Cadila Healthcare in trouble

    Medical Dialogues BureauBy Medical Dialogues BureauPublished On 2019-11-07T16:20:51+05:30  |  Updated On 2021-08-17T10:46:27+05:30

    Cadila Healthcare Ltd., Glenmark Pharmaceuticals Ltd. and Lupin Ltd. are the latest local medicine makers to be reprimanded by the US Food and Drug Administration, exchange filings show.


    New Delhi: Three major Indian drugmakers received warning letters from the US health care watchdog in the last two months, highlighting that the country's copycat drug sector is still plagued by quality issues amid rising global concern over tainted drug supplies.


    Cadila Healthcare Ltd., Glenmark Pharmaceuticals Ltd. and Lupin Ltd. are the latest local medicine makers to be reprimanded by the US Food and Drug Administration, exchange filings show. A plant with a warning letter is barred from introducing new products in the US, stymieing the company's ability to grow revenue in the world's top pharmaceutical market.


    The latest regulatory crackdown shows the US regulator's stance is hardening toward lapses in quality control even as it seeks cheaper drugs to contain health care costs. Indian pharmaceutical factories collectively produce about 40 per cent of the American generic drug supply and have been faulted in the past by the FDA for everything from lax documentation to open toilet drains and malfunctioning equipment.


    Read Also: Zydus Cadila receives warning letter from USFDA for Moraiya-based formulation facility


    The USFDA is struggling to contain the damage after carcinogenic chemicals were discovered in generic drugs to control blood pressure and stomach acid, prompting drug makers in India and elsewhere to recall the medicines.


    Cadila Healthcare received a warning letter against its Moraiya facility in the western state of Gujarat, it said in a Nov. 4 filing, about three years after a previous warning letter against this plant was lifted.


    Glenmark told exchanges in October that its manufacturing site in Baddi in Himachal Pradesh has got a similar letter, without elaborating on the reasons for this regulatory action. Lupin informed investors Sept. 19 that its Mandideep plant had also got a warning letter. The US FDA said it had found similar quality control lapses at Lupin's two other sites too.


    By Ari Altstedter


    Read Also: Torrent Pharma shares slump 3pc on USFDA warning letter for Gujarat facility

    Baddi plant Cadila Cadila Healthcare cancer carcinogenic Glenmark Glenmark Pharma Healthcare Indian pharma factories​ Lupin Mandideep facility Moraiya facility pharma pharma company pharma news USFDA USFDA warning warning letters 
    Source : Bloomberg

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    Medical Dialogues Bureau
    Medical Dialogues Bureau

      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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