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April 30, 2014

Pharmalucence Aseptic Fill and Finish Facility Milestone - DMF Submission

Pharmalucence has achieved a significant milestone on its way to bringing its new aseptic drug production facility in Billerica, MA into full operation.  On April 29, we submitted our DMF, a comprehensive description of facility equipment, operations and validation, to the FDA.  This step will be followed by submission of our Prior Approval Supplement (PAS) for transfer of the production of our Sulfur Colloid kit to the new facility.  The PAS submission will trigger an FDA inspection as the last step toward final approval.  This inspection is anticipated within four months from the time of our sending the PAS.  Assuming an acceptable FDA inspection, Pharmalucence expects to begin drug manufacturing at the Billerica, MA site in early Q4 of this year.





For more information, please contact:
John Felock
Director; Sales, Marketing and Customer Service
1-781-687-1245
jfelock@pharmalucence.com



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