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    Glenmark Pharma shares tank 10% as USFDA issues warning letter for Baddi facility

    Glenmark Pharma shares tank 10% as USFDA issues warning letter for Baddi facility

    Glenmark Pharma shares tank 10% as USFDA issues warning letter for Baddi facility
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    By CNBC-TV18  IST (Published)

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    Glenmark Pharma stock tanked 10 percent on Monday to touch its 52-week low after the US Food & Drug Administration (USFDA) issued a warning letter to the company's Baddi facility.

    Glenmark Pharma stock tanked 10 percent on Monday to touch its 52-week low after the US Food and Drug Administration (USFDA) issued a warning letter to the company's Baddi facility.
    The stock fell 10 percent to its 52-week low of Rs 284.40 per share on BSE. At 12:15 pm, the stock was trading 9.4 percent lower at Rs 285.85 as compared to a 0.5 percent or 194 points rise in BSE Sensex at 37,867.
    The inspection was conducted at the Baddi facility in Himachal Pradesh between April 15 and April 20 and the company had earlier informed bourses that the inspection was classified as 'official action indicated' vide a letter by USFDA.
    "With regards to the same inspection, the USFDA has now issued a warning letter to the Baddi facility. The company is committed to work along with the USFDA to implement all the necessary corrective actions required to address the concerns raised in the letter and is in the process of preparing a detailed response to the USFDA within 15 working days," the firm said in a BSE filing.
    The company said that it believes that the existing manufacturing and the sale of products from this facility will not be impacted. Glenmark's Baddi facility is expected to contribute $30 million in total sales for this financial year which is approximately 7 percent of its total US sales, the filing added.
    There are no major pending approvals from this facility in the next 12 months. There will be no financial impact on the organisation on account of this development, the firm said.
    Glenmark currently has eight manufacturing facilities approved by the USFDA — five formulations facilities and three API facilities under Glenmark Life Sciences Limited. None of these facilities except Baddi has any outstanding issues with the USFDA at this point in time.
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