Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
August 18, 2025
Approximately 5 minutes
Understanding the Drug Master File (DMF) for Pharmaceutical APIs
Understanding the Drug Master File (DMF) for Pharmaceutical APIs
A Drug Master File (DMF) is a confidential document submitted to regulatory authorities (such as the FDA or EMA) that provides detailed, proprietary information about the manufacturing, facilities, quality control, and stability of an Active Pharmaceutical Ingredient (API).
The Purpose of a DMF
The primary objective of a DMF is to support the regulatory review process for a finished drug product. It allows an API manufacturer to protect their intellectual property and trade secrets while providing the necessary data for safety and efficacy evaluations.
Key features include:
- Confidentiality: The regulatory authority reviews the document, but the drug product manufacturer (the customer) does not see the proprietary manufacturing details.
- Letter of Authorization (LOA): The API manufacturer provides an LOA to the drug product manufacturer, allowing them to reference the DMF in their own New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Structure and Content: The ICH CTD Format
Most DMFs follow the International Council for Harmonisation (ICH) Common Technical Document (CTD) format. The typical sections include:
1. General Information
Details the nomenclature, chemical structure, and physical properties of the drug substance.
2. Manufacture
Contains a complete description of the manufacturing process, the materials used, intermediates, and the specific manufacturing site information.
3. Characterization
Evidence proving the API's chemical structure. This usually includes data from Infrared Spectroscopy (IR), Nuclear Magnetic Resonance (NMR), and Mass Spectrometry (MS), along with information on polymorphism and isomerism.
4. Control of Drug Substance
Outlines the quality control specifications, analytical procedures, and the validation data required to prove the reliability of these testing methods.
5. Stability and Packaging
- Container Closure System: A description of the materials used for primary packaging.
- Stability: Long-term and accelerated testing data demonstrating how the API maintains quality over time under specified storage conditions.
By maintaining a robust DMF, API manufacturers ensure their products are globally competitive and compliant with the highest pharmaceutical safety standards.