Sun Pharmaceutical Industries Limited — EU GMP NCR (EudraGMDP) Findings

Critical finding #1: Impact assessments of major deviations, which have impact on the validated status of the process, are not performed sufficiently, and in a timely manner. Impact on batches in the market is insufficiently assessed. This was observed in 13 out of 57 assessed products marketed in the EU, namely: Atorvastatin tablets, Isotretinoin capsules, Olanzapine tablets, Candesartan tablets, Levetiracetam tablets, Esomeprazole capsules, Esomeprazole tablets, Gliclazide tablets, Pantoprazole tablets, Perindopril tablets, Ramipril tablets, Rosuvastatin tablets and Valsartan tablets. Critical finding #2: The extent to which SPL communicates significant product quality-related issues with the EU batch release site and EU authorities is not sufficient. The involvement of the EU QP in any ongoing investigations, rejections, OOS/OOT results and other notifications, which could affect the quality of EU products is insufficient. Involvement of the EU-QP in the product assessment reports could not be demonstrated. EU-QP involvement was only demonstrated during recalls. Action taken/proposed by the NCA: Withdrawal, of current valid GMP certificate No. NL/H 24/2049272 IGJ has the intention not to grant a new GMP certificate and to issue a Non-Compliance Statement upon finalization of the inspection report. This proposed decision was communicated with the company upon receival of the draft inspection report from IGJ. Following this decision the current GMP certificate (NL/H 24/2049272) previously granted based on the previous inspection in October 2023 will be withdrawn from EudraGMDP. Because of the second critical finding, IGJ has decided to not follow the option of issuing a partial GMP certificate. A re-inspection will be performed on the basis of the company plan of action to address the deficiencies (currently not scheduled yet). After a positive result following the re-inspection a new GMP certificate will be issued and this Non-Compliance Statement withdrawn. Recall of batches already released At present, IGJ is awaiting an assessment which products are considered critical for the Dutch market. At the same time, IGJ is awaiting an impact assessment from the MAH for continued batch certification. Therefore, currently not all information is available to determine whether a recall is deemed necessary based on the critical findings. IGJ is only considering market actions for the 13 products that are in scope of the first critical finding (see restrictions in Part 2). Each Member State is asked to determine, based on the provided product list of this Sun-site, which medicinal products are considered critical for the national market. In case IGJ decides on market actions required, a rapid alert will be initiated separately.