Biopharma PEG Announces FDA DMF Registration for mPEG-pAld (20K)
Date
1/18/2025 3:47:17 AM
(MENAFN- Biopharma PEG Scientific Inc.) Biopharma PEG, a leading manufacturer of high-quality polyethylene glycol (PEG) derivatives, today announced that its mPEG-pAld (20K) product has successfully achieved DMF (Drug Master File) II registration with the U.S. Food and Drug Administration (FDA) under DMF number 040600.
“We are thrilled to receive FDA DMF registration for our mPEG-pAld (20K) product,” said Sonia Lee, Marketing Director at Biopharma PEG. “This achievement demonstrates our commitment to providing our customers with the highest quality materials for their drug development programs. We are confident that this registration will help to streamline and accelerate the development of new drugs.”
mPEG-pAld (20K) is a monomethoxy poly(ethylene glycol) derivative with a p-aldehyde functional group. It is a versatile building block that can be used in a variety of applications, including:
• Drug conjugation
• Targeted drug delivery
• Bioconjugation
• Biomaterials science
Why Choose Biopharma PEG?
• Exceptional Purity and Consistency: Biopharma PEG’s strict quality controls guarantee high purity and reliable batch-to-batch consistency, meeting global standards.
• Regulatory Expertise: FDA DMF certification ensures full regulatory support to streamline and accelerate drug development.
• GMP Standards: GMP-compliant production with support from R&D to kilogram-scale manufacturing, meeting diverse needs.
“We are committed to providing our customers with the best possible products and services,” said Ms. Lee. “We look forward to working with our customers to bring new and innovative drugs to market.”
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Biopharma PEG Scientific Inc.
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