Glycogene Continues to Make Breakthroughs: Various Phosphoramidite Monomer Products Receive FDA DMF Filings!
Release time:
2024-09-06
Summary:Recently, Glycogene received a confirmation letter from the U.S. Food and Drug Administration (FDA) stating that all 8 phosphoramidite monomer products submitted by the company have officially completed the Drug Master File (DMF) filing with the FDA. This marks the first time globally that phosphoramidite monomer products have completed DMF filing with the FDA. The 8 products submitted are part of the 2'-O-Me and 2'-F series, which are frequently used in small nucleic acid drugs.
Recently, Glycogene received a confirmation letter from the U.S. Food and Drug Administration (FDA) stating that all 8 phosphoramidite monomer products submitted by the company have officially completed the Drug Master File (DMF) filing with the FDA. This marks the first time globally that phosphoramidite monomer products have completed DMF filing with the FDA. The 8 products submitted are part of the 2'-O-Me and 2'-F series, which are frequently used in small nucleic acid drugs.
Drug Master File (DMF) is a document submitted by pharmaceutical companies to regulatory authorities (such as the U.S. FDA) to provide confidential information about drug substances, intermediates, packaging materials, and other related components. It typically includes Chemistry, Manufacturing, and Controls (CMC) data, stability data, packaging material data, and other relevant information to verify the quality, safety, and efficacy of the product.
After completing the DMF filing, when you use Glycogene DMF-filed products for FDA submissions, you can directly reference the corresponding DMF number instead of providing detailed information about the raw materials and excipients during the submission process. This not only reduces approval costs but also enhances approval efficiency, helping to accelerate the regulatory submission process for your related drug projects.
Product Advantages
1. GMP Compliance
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The products are manufactured under a GMP (Good Manufacturing Practice) quality management system, ensuring the controllability and traceability of materials and processes. We are fully prepared to support customer on-site audits at any time.
2. High Purity
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The product purity exceeds 99%, with strict control over moisture, residual solvents, and other impurities.
3. Large-Scale Production
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Annual production capacity reaches ton-scale per product.
4. Self-Production
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Core raw materials, such as the 2-F nucleoside series, are produced in-house, ensuring quality and supply chain stability.
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