ABOUT THE EVENT
In its continuous efforts to facilitate and support the development and market authorization of complex generic drugs FDA has recently finalized the Guidance for Industry “ANDA for Certain Highly Purified Synthetic Peptide Drug Product That Refer to Listed Drugs of rDNA Origin”.
Although this guideline provides clarity with respect to requirements and review process for complex generics of certain nature, scientific and regulatory challenges remain a big hurdle on the way to successful approval of generic drugs falling under this guideline.
Bachem as the leading manufacturer of synthetic peptide APIs and technological front-runner has decades of experience in production, analytical characterization and regulatory submission of complex generic peptides.
Please join our Webinar to get to know about our unique practical experience with compliance with the ANDA Guideline and how we can support your generic drug development with our high quality peptide APIs as well as analytical and regulatory knowhow.