Impax smacked after FDA inspection


Shares of Impax Laboratories (IPXL -14.6%) plunge on a 7x surge in volume after an FDA inspection of its Taiwan manufacturing facility. The site makes 12 products for U.S. distribution and will produce Ryatary, the firm's drug candidate for Parkinson's disease.

The inspection notes contain numerous references to GMP violations. Investors perceive that the deficiencies could jeopardize the company's product supply.

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Comments (2)
  • Joe McCann
    , contributor
    Comments (261) | Send Message
     
    The severity of a 483 can vary widely. One of the most common times I used an FOIA request when working at a hedge fund was to see if there were outstanding 483s.

     

    After finding one I would speak to a cGMP expert (typically recently retired) to understand how serious the 483 actually was.

     

    Join me in this project: http://bit.ly/1toPgvi
    and find out the likelihood that IPXL's supply chain will actually be disrupted or if this is a buying opportunity.
    29 Jul 2014, 04:31 PM Reply Like
  • petergrt
    , contributor
    Comments (541) | Send Message
     
    I never thought that I will ever be able to buy this stock for under $28 . . . . . so I bought a few k for > $24 today.

     

    I think that it is the next Actavis . . . . they too had a pile of plant problems as they acquired ADRX . . . .

     

    IPXL has a ton of cash ($6/share) - they should be able to buy a decent producer.

     

    Alternatively, they maybe acquired.
    29 Jul 2014, 04:33 PM Reply Like
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