Cadchem Laboratories Limited — EU GMP NCR (EudraGMDP) Findings

Critical and major GMP deficiencies were identified during the inspection of the manufacturing site in the frame of EDQM's inspection programme. These included significant failures in quality management oversight, data integrity, materials management, equipment cleaning and maintenance, and facility conditions. The deficiencies demonstrated a lack of effective quality system and inadequate control over GMP-relevant operations. Critical data integrity issues were observed, undermining the reliability of manufacturing and quality control data. Due to the systemic nature of the deficiencies, it cannot be ensured that active substances manufactured at the site comply with EU GMP requirements. No specific evidence of defective batches placed on the market was identified during the inspection. Action taken/proposed by the NCA: Suspension or voiding of CEP (action to be taken by EDQM) The EDQM AdHoc Committee decided to suspend the following CEPs: CEP 2019-123 / Clopidogrel hydrogen sulfate, CEP 2020-318 / Levetiracetam, CEP 2023-153 / Rosuvastatin calcium, CEP 2024-419 / Thioctic acid. Furthermore, the EDQM AdHoc Committee decided to remove Cadchem Laboratories Limited as intermediate manufacturer from CEP 2017-247, CEP 2014-176, CEP 2021-052 and CEP 2025-295.