We are excited to announce that Leadgene has successfully registered several key products with the US FDA Drug Master File (DMF).
A Drug Master File (DMF) is a submission to the U.S. Food and Drug Administration (FDA) that provides confidential, detailed information about the manufacturing, processing, packaging, and storage of drug substances, drug products, or excipients.
The information contained in a DMF can be referenced to support regulatory filings, such as IND (Investigational New Drug Application), NDA (New Drug Application), and BLA (Biologics License Application), helping to streamline the drug development and approval process.
The following products have been successfully registered:
These successful registrations reflect our unwavering commitment to providing high-quality, GMP-grade biological materials that meet global regulatory standards.
We look forward to continuing our support for partners and clients in advancing drug development and helping bring innovative therapies to market.
