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MedPharm Completes FDA Inspection

No 483s issued at its Durham, NC CoE

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By: Tim Wright

Editor-in-Chief, Contract Pharma

MedPharm, a global contract development organization for topical and transdermal products, has successfully completed a pre-approval inspection by the FDA at its facility in Durham, NC. The inspection took place between January 27-31. The FDA inspectors found the site to be compliant and no Form 483 observations issued.   The inspection was triggered by data generated by MedPharm as part of a client’s ANDA for a generic topical product. The ANDA submission used MedPharm’s in vitro models to demo...

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