MedPharm, the leading global contract development organisation for topical and transdermal products, has successfully completed a preapproval inspection by the FDA at its facility in Durham (NC, US).
The inspection took place on 27–31 January. The FDA inspectors found the site to be compliant and no Form 483 observations were 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 demonstrate the bioequivalence of the new generic to the originator in line with the new FDA guidelines.
"The successful outcome of this inspection by the FDA is a direct reflection of the innovation and quality inherent in everything MedPharm does and a strong endorsement of the integrity and diligence of our scientific team," commented Eugene Ciolfi, MedPharm’s President and CEO.
"I would like to congratulate the Durham team as well as the entire MedPharm global group. This underlines the quality of the sophisticated and proprietary in vitro models MedPharm has developed to de-risk clients’ development programmes."
