By Bachem AG
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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.
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