Sichuan New Hawk Biotechnology Co. Ltd. — EU GMP NCR (EudraGMDP) Findings

An on-site GMP inspection was carried out for the first time in April 2026 for the manufacturing of API Diosmin. This was an inspection carried out in frame of the EDQM´s inspection programme to assess the compliance with Part II EU GMP guidelines and the approved CEP dossier (CEP 2016-173). The inspectors identified 1 critical, 8 major, 17 other deficiencies and 4 CEP dossier / CEP holder responsibility violations. The critical finding was related to the validity and integrity of data generated in the QC laboratory using the HPLC system. Final release results for Diosmin API could not always be relied upon as the testing for related substances and assay was not always performed in accordance with the company’s internal method of analysis nor the CEP dossier. Specifically, system suitability and reference standard (a) injections were not included in the sequences for multiple batch analyses. Of the 30 batches released to Europe since the beginning of 2023, 24 batches had been tested without system suitability and reference standard (a) injections in the same sequence as the sample analysis. These analyses referenced system suitability and references standard injections from different sequences carried out either before (e.g. up to 14 days) or after (e.g. up to 12 days) the sample analysis. Therefore, the sequences from which this data was obtained could not be considered as valid to support product release. Significant gaps were identified in HPLC controls, including missing system suitability tests, absent or incomplete sample receipt logs, and lack of traceability for certain batches. Documentation did not support batch classification (e.g. R&D vs production), and duplicate analyses of the same batch lacked clear differentiation, creating a risk of sample mix-ups. Additionally, procedures for data backup were incomplete, and system access rights were not managed per SOP, with inappropriate privileges granted to the QP. 8 major deficiencies were identified related to rejection and re-use of materials and recovered materials, quality management, process equipment, documentation and records, production and in-process controls, packaging and labelling of APIs and intermediates and change control. Action taken/proposed by the NCA: Suspension of the marketing authorisation(s) Suspension of Marketing Authorisation Recall of batches already released List of Diosmin batches released to EU from 2023 to 2025: PXC03231109, PXC03231110, PXC03240438, PXC03240439, PXC03240440, PXC03240441, PXC03240442, PXC03240821, PXC03241219, PXC03250401, PXC03250508, PXC03250524, PXC03250624, PXC03250625, PXC03250809, PXC03250810, PXC03251023, PXC03251024, PXC03251025, PXC03251026, PXC03251027, PXC03251223, PXC03251224, PXC03251225, Prohibition of supply API Diosmin Suspension or voiding of CEP (action to be taken by EDQM) CEP 2016-173/Diosmin & CEP 2024-194 /Diosmin, micronized; both CEPs have been suspended by EDQM on 11 June 2026