US FDA DMF (Drug Master File)

DMFs are typically submitted by manufacturers of:

• Active Pharmaceutical Ingredients (APIs)
   
• Excipients
   
• Pharmaceutical Packaging Materials
   

DMFs are not mandatory, but they are commonly used to support New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Investigational New Drug Applications (INDs). This allows the FDA to independently review the confidential manufacturing details without disclosing proprietary information to the finished product applicant.

DMFs are not mandatory, but they are commonly used to support New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Investigational New Drug Applications (INDs). This allows the FDA to independently review the confidential manufacturing details without disclosing proprietary information to the finished product applicant.

The DMF typically includes:

• Raw material specifications
   
• Manufacturing processes and controls
   
• Stability data
   
• Facility details and GMP compliance
   
• Quality control procedures
   

Due to the technical complexity and regulatory importance of DMFs, expert preparation and submission are critical to avoid delays or rejections.

RAPS – Your Strategic Partner for US FDA DMF Preparation

With regulatory expertise and global presence, RAPS ensures that your Drug Master File is accurately prepared, compliant, and submission-ready.

 DMF Type II, III, IV & V expertise
Complete document preparation and filing
Support for DMF referencing in NDAs/ANDAs/INDs End-to-end regulatory consulting

 Contact RAPS today to ensure your DMF submission meets all FDA requirements—on time and with confidence.

Navigating Drug Master File (DMF) regulations requires precision, expertise, and confidentiality. With RAPS, you get a trusted regulatory partner who understands the technicalities and expectations of the US FDA.

☆ What We Offer:

• Complete DMF documentation & submission
   
• US Agent services from our US-based office
   
• eCTD conversion and compliant formatting
   
• Direct FDA query handling on your behalf
   
• Secure, confidential data management
   
• Fast turnaround times (2–3 months)
   

 Affordable Plans Starting at $2,500

 Get in touch today for a customized quote and ensure your DMF submission is accurate, timely, and fully FDA-compliant.

RAPS – Your Global DMF Compliance Partner.