Generic Drug Development CDMO

Introduction Phase-Appropriate CMC Development at a CDMO represents a risk-managed approach to scaling that aligns Chemistry, Manufacturing, and Controls activities […]

Introduction: FDA Sameness for Complex Generic Drugs is a scientific and regulatory assessment used to determine whether a proposed generic

Introduction: Technology Transfer to GMP CDMO is one of the most technically demanding steps in bringing a first-in-generic modified-release tablet

Introduction A peptide purity testing report, commonly presented as a Certificate of Analysis (CoA) or analytical datasheet, is a critical

Introduction When a Complete Response Letter (CRL) is issued for a Generic ANDA under 21 CFR 314.110, the applicant immediately

Introduction The choice between the 505(b)(2) vs ANDA Regulatory Pathway depends largely on whether the proposed drug product is an

Introduction Pharmaceutical sponsors can execute a Switch CDMO After ANDA Submission, but the regulatory approach depends on whether the ANDA

Introduction An Abbreviated New Drug Application (ANDA) submission requires stability data from a minimum of three primary exhibit batches, which

Introduction: CDMO support for ANDS can provide generic drug sponsors with the scientific, analytical, manufacturing, and documentation capabilities needed to

Introduction: For any company preparing to file an Abbreviated New Drug Application (ANDA), a Comparative Dissolution Study for ANDA is