Sunresin Bioprocess Materials Achieve DMF Registration, Supporting Global Biopharma Compliance
In the highly regulated global biopharmaceutical supply chain, compliance and quality of chromatography media are mission-critical. To meet the technical filing requirements of regulatory authorities such as the U.S. FDA and European EMA, Sunresin has been actively advancing Drug Master File (DMF) registration for its life science-grade chromatography products, and has made significant progress.
As of today, Sunresin has obtained DMF numbers for 10 chromatography products, with another 9 under active review, covering a wide range of chromatographic modes including ion exchange, affinity, mixed-mode, and hydrophobic interaction. These DMF-registered products help pharmaceutical customers accelerate regulatory submissions across global markets.
What is a DMF and Why Does It Matter?
A Drug Master File (DMF) is a confidential technical dossier submitted to regulatory agencies such as the FDA and EMA. It contains detailed information on raw materials, manufacturing processes, analytical methods, and quality controls.
For chromatography media used in the production of antibody drugs, vaccines, and gene therapies destined for the U.S. or European markets, DMF registration serves as a crucial “passport” for market entry.
Benefits for biopharma companies:
✅ Simplifies regulatory filings (IND, BLA, NDA) by referencing the DMF number
✅ Eliminates the need to resubmit raw material and quality documents
✅ Serves as authoritative proof of GMP and pharmacopeia compliance
DMF-Registered Products (Selection):
Below is a sample list of chromatography products that have obtained DMF registration numbers to date.
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Sunresin: Beyond Materials, A Partner in Bioprocess Solutions
With over 20 years of experience in chromatography resin development and biopharmaceutical manufacturing, Sunresin operates a mature GMP-compliant production platform and serves customers across global markets.
We are more than a material supplier — we provide full-spectrum support including:
- Regulatory-compliant raw material & process design
- DMF filing documentation and assistance with customer submissions
- IND/NDA project coordination support
- Customized chromatography solutions for monoclonal antibodies, vaccines, and gene therapies
Looking Ahead
Sunresin will continue to expand its DMF-registered product portfolio and strengthen its global regulatory framework. We are committed to delivering high-quality, compliant, and efficient solutions to support the innovation of life science companies worldwide.
Choose Sunresin. Empower global biologics with high-performance chromatography materials made in China. Together, we advance the future of life sciences.
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Modern biopharmaceutical technologies typically use biological microbial fermentation...
PFAS Removal
Chemical Industry
Purification of chemical compounds has become a vital part of most industrial processes.
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Drinking water is essential to life. Every day every human being has to drink and use water for food preparation.
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Food is closely related to everyone, and the finishing of food comes from people's relentless pursuit...
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Hydrometallurgy is a technique for extractive metallugry involving the three general area...
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Sunresin is the major DLE lithium sorbent producer in China which mainly used for extraction lithium from salar brine and geothermal brine etc with high efficiency.
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Sunresin Bioprocess Materials Achieve DMF Registration, Supporting Global Biopharma Compliance
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