MPI’s Drug Master File (DMF) Solutions

A Drug Master File (DMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) containing detailed information about facilities, processes, or articles used in the manufacturing process, packaging, and storing of one or more human drugs. This DMF is crucial in the regulatory compliance process as it allows for a comprehensive review of the drug product, ensuring that it meets all necessary regulatory requirements for safety, quality, and efficacy.

Medical Packaging Inc., LLC’s Drug Master File marks a key regulatory milestone, making our machines and materials trusted by pharmaceutical companies and healthcare facilities to address compliance burdens, labeling errors, and manual packaging inefficiencies.

The FDA plays a pivotal role in reviewing and accepting DMF submissions, with this process being integral to clinical development and drug evaluation phases, especially for new drugs and investigational new drug applications. The acceptance and review process of a DMF by the FDA signifies validation of quality control and manufacturing processes involved in drug product production, thereby confirming adherence to the highest standards of regulatory affairs and pharmaceutical compliance.

Medical Packaging Inc., LLC (MPI) has proudly achieved a milestone with the original submission and acceptance of a Type III Drug Master File, with this specific DMF number relating to packaging materials and underscoring MPI’s commitment to excellence in pharmaceutical packaging for hospitals and acute care facilities, specialty pharmaceutical manufacturers, and pharmaceutical repackagers. 

Comprehensive Documentation for Regulatory Success

We disclosed every packaging material, component, intended usage, as well as manufacturer information to demonstrate our product quality and support regulatory submissions. Having our own DMF means MPI can now provide more direct and efficient support to our customers, addressing critical pain points including:

• Limited automation for both low- and high-volume packaging needs
• Difficulty integrating packaging systems into existing workflows
• Complex export application requirements for international markets
• Additional information requests from regulatory agencies

This eliminates reliance on third-party vendors for critical regulatory and technical documentation, reducing potential delays in FDA regulations filings and new drug application processes.

The FDA’s acceptance of MPI’s Drug Master File marks a significant achievement in our commitment to pharmaceutical packaging excellence. This milestone enables us to provide faster, more efficient support for NDA and ANDA submissions, protect confidential data, and deliver clear documentation for regulatory review. Our DMF also supports investigational submissions, draft guidance compliance, and coordination of active substance primary files when required.

By streamlining the process through our FDA-accepted DMF, we ensure that our customers can focus more on their core activities like clinical trials, drug development, and marketing authorization without the added regulatory burden. Our comprehensive approach addresses the full spectrum of packaging challenges while maintaining the highest standards of regulatory compliance.

Speed to Market Advantages

• Reduced regulatory review timelines
• Streamlined drug approval process support
• Enhanced drug evaluation efficiency
• Optimized pharmaceutical manufacturer operations

Operational Excellence

• Elimination of inefficient manual packaging processes
• Advanced automation for consistent quality control
• Integrated systems reducing labeling errors
• Scalable solutions for diverse volume requirements

Regulatory Confidence

• FDA-validated packaging materials and processes
• Regulatory agency accepted documentation
• Complete information readily available for submissions
• Ongoing support for annual report requirements

As Medical Packaging Inc., LLC continues to evolve and grow, our DMF is more than just a certification; it is a testament to our unwavering commitment to quality, safety, and regulatory excellence. We are proud to lead the way in providing innovative, FDA-compliant packaging solutions, contributing to the advancement of healthcare and patient well-being in the United States and global operations.

Center for Drug Evaluation and Research. “Drug Master Files: Guidelines.” U.S. Food and Drug Administration, FDA, www.fda.gov/drugs/guidances-drugs/drug-master-files-guidelines. Accessed 11 Dec. 2023.