Introduction The FDA’s Product-Specific Guidance for Tirzepatide outlines the regulatory, analytical, formulation, and drug-device combination product requirements that generic manufacturers […]
FDA Product-Specific Guidance for Tirzepatide: A Complete ANDA Development Roadmap Read More »
Introduction The decision to adopt a consolidated or split Drug Substance vs Drug Product CDMO model plays a pivotal role
Drug Substance vs Drug Product CDMO: Understanding the Split and When to Use Each Read More »
Introduction Obtaining approval for an Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) requires manufacturers
Introduction How to Choose a Peptide CDMO? Sponsoring organizations must perform a comprehensive technical audit that assesses chemical synthesis platforms,
Introduction: For sponsors planning an Abbreviated New Drug Application (ANDA) or Abbreviated New Drug Submission (ANDS), one of the first
How Long Does Generic Drug Development Take at a CDMO? Timeline Expectations Explained Read More »
CDMO Technology Transfer Peptide Technology Transfer: A Sponsor’s Step-by-Step Guide to Moving Programs Between CDMOs By Anusha Sinha • July
Introduction Synthetic peptide active pharmaceutical ingredients (APIs) present unique regulatory and analytical challenges because conventional International Council for Harmonisation (ICH)
