Medical Packaging Inc., LLC (MPI) is pleased to announce that the company has completed a Type III Drug Master File (DMF) submittal to the U.S. Food & Drug Administration (FDA). This will enhance MPI’s customer partnerships by providing speed-to-market regulatory and technical support related to our packaging components with our medical and pharmaceutical market clients.
Establishing a DMF enables MPI to rapidly support customers’ compliance and filing needs within the pharmaceutical industry as well as meet the needs of pharmaceutical drug manufacturers and contract drug manufacturing organizations (CDMOs) for FDA-compliant liquid cup packaging capabilities.
“Typically, MPI has relied on our vendors and sub-vendors to obtain all necessary regulatory and technical documents, sometimes adding delays while awaiting critical support files, which could result in delayed FDA Filings by customers. Having a DMF allows us to better support our customers in meeting and exceeding expectations for regulatory and technical requirements, confirming a high-quality, safe product is delivered, and expediting the application process during a New Drug Application (NDA) or Abbreviated New Drug Filing (ANDA),” said John Zripko, President & CEO for MPI.