Bachem capabilities to address the new FDA guideline for synthetic peptides скачать в хорошем качестве

Bachem capabilities to address the new FDA guideline for synthetic peptides

In its continuous efforts to facilitate and support the development and market authorization of complex generic drugs the 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 requirement and review processes for complex generics of a 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. Speaker: Sergey Malashikhin, Ph.D. Group Leader Generics – Business Development at Bachem AG Bachem capabilities to address the new FDA guideline “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products” Chapters: 00:00 Webinar introduction 07:38 Keynote speaker presentation 30:30 Audience questions ________________________________________________________________________ About Bachem: Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com. Learn more about our products and services at https://www.bachem.com/​ Bachem. Leading Partner in Tides