Introduction: Dexamethasone Injection CMC requirements are a critical part of developing and submitting a generic injectable drug product through the […]
CMC Requirements for Dexamethasone Injection ANDA Read More »
Introduction: Silicone Lubricant Leachables are chemical substances that can migrate from silicone-lubricated components of a pharmaceutical container or drug-delivery system
Case Study: Silicone Lubricant Leachables in an Auto-Injector Primary Container Read More »
Introduction: The development of a PLGA Long-Acting Injectable Formulation for a GLP-1 receptor agonist can provide an important strategy for
Introduction Pharmaceutical sponsors can execute a Switch CDMO After ANDA Submission, but the regulatory approach depends on whether the ANDA
Can You Switch CDMOs After an ANDA Has Been Submitted to the FDA? Read More »
Introduction Analytical Method Development and Impurity Profiling for complex cyclic peptide active pharmaceutical ingredients (APIs) establishes the analytical foundation necessary
Introduction: Peptide-oligonucleotide conjugate (POC) developers face a question that shapes every downstream decision — from IND strategy to exclusivity planning:
Are Peptide-Oligonucleotide Conjugates Regulated as Small Molecules or Biologics? Read More »
Introduction Optimizing Linker Hydrolytic Stability is a foundational chemical strategy for preventing premature payload dissociation during systemic circulation while still
Introduction An Abbreviated New Drug Application (ANDA) submission requires stability data from a minimum of three primary exhibit batches, which
Introduction Choosing an appropriate Good Manufacturing Practice (GMP) manufacturing partner for custom peptide synthesis services requires a detailed assessment of
Custom Peptide Synthesis Services: What to Look for in a GMP Manufacturing Partner Read More »
Introduction: CDMO support for ANDS can provide generic drug sponsors with the scientific, analytical, manufacturing, and documentation capabilities needed to
How CDMOs Support Abbreviated New Drug Submission (ANDS) for Health Canada Approval Read More »
