Current list of CEP Suspensions, Withdrawals, Restorations

The vast majority of approved medicinal products in Europe contain active pharmaceutical ingredients (APIs), which are described concerning their quality in related API specific monographs of the European Pharmacopoeia. It is an option for these medicinal products to substantiate the API quality part of a drug product application by a CEP certificate (Certificate of Suitability to the Monographs of the European Pharmacopoeia CEP) of the European Directorate for the Quality of Medicine (EDQM).

The EDQM conducts risk-based inspections of manufacturing sites in order to prove the GMP compliance and conformity of the approved dossier with the API manufacturing on site. As a result the CEP may be suspended or even withdrawn due to different underlying reasons. The following list of current EDQM inspection results is based upon the EDQM website and the related EDQM data base. Blue inspection body GmbH assumes no responsibility or warranty for the accuracy or completeness of the given data.

Even with the availability of a valid CEP certificate the European drug manufacturers are obliged to monitor their API suppliers professionally and rigorously either themselves or on behalf of them by third parties. These audits of the API manufacturing sites are therefore also in the best interest of the pharmaceutical manufacturers, since the suspension or withdrawal of a CEP is typically connected with a considerable expenditure and a loss of turnover.

You can search for current GMP certificates and current GMP non-compliance information via the EudraGMDP database.

Current list of CEP Suspensions, Withdrawals, Restorations

You can sort the list by clicking the headlines „Ingredient“, „Manufacturer“, „CEP No.“ etc.

IngredientManufacturerCountryCEP No.DateActionReason
Acamprosate calciumEstechpharma Co., Ltd.South KoreaR1-CEP 2001-160-Rev 0211.04.13Withdrawal2
AceclofenacEstechpharma Co., Ltd.South KoreaR1-CEP 2004-006-Rev 0011.04.13Withdrawal2
AceclofenacAmoli Organics Priv Ltd.IndiaR0-CEP 2006-050-Rev 0022.06.12Suspension5
Acetylsalicylic acidIndustria Quimica Andina & Cia. S.A.ColombiaR0-CEP 2006-195-Rev 0020.04.12Withdrawal3
Amlodipine besilateSmruthi Organics Ltd.IndiaR0-CEP 2007-285-Rev 0122.02.13Suspension5
Amoxicillin sodium sterileZhuhai United Laboratories Co., Ltd.ChinaR0-CEP 2013-125-Rev 0113.05.15Suspension2
Amoxicillin trihydrateParabolic Drugs Ltd.IndiaR1-CEP 2004-266-Rev 0129.07.15Withdrawal2
Ampicillin trihydrateParabolic Drugs Ltd.IndiaR0-CEP 2011-083-Rev 0029.07.15Withdrawal2
Ampicillin, anhydrousParabolic Drugs Ltd.IndiaR0-CEP 2011-090-Rev 0029.07.15Withdrawal2
Articaine hydrochlorideSynteco S.p.A.ItalyR1-CEP 2001-453-Rev 0110.04.15Suspension1
Articaine hydrochlorideS.I.M.S. S.R.L.ItalyR0-CEP 2009-137-Rev 0009.02.15Restoration
AzathioprineRPG Life Sciences LimitedIndiaR1-CEP 2001-341-Rev 0204.07.13Restoration
Bacampicillin hydrochlorideParabolic Drugs Ltd.IndiaR0-CEP 2011-106-Rev 0029.07.15Withdrawal2
Benzylpenicillin, procaineNorth China Pharmaceutical Group Semisyntech Co., Ltd.ChinaR1-CEP 2004-001-Rev 0103.03.15Withdrawal2
Benzylpenicillin, procaineNorth China Pharmaceutical Group Semisyntech Co., Ltd.ChinaR1-CEP 2004-017-Rev 0103.03.15Withdrawal2
Bupivacaine hydrochlorideS.I.M.S. S.R.L.ItalyR1-CEP 2001-013-Rev 0109.02.15Restoration
BuprenorphineRusan Pharma Ltd.IndiaR0-CEP 2007-065-Rev 0013.11.12Suspension2
Buprenorphine hydrochlorideRusan Pharma Ltd.IndiaR1-CEP 2001-278-Rev 0213.11.12Suspension2
CaffeineTianjin Zhongan Pharmaceutical Co., Ltd.ChinaR0-CEP 2005-116-Rev 0114.01.13Withdrawal3
CaffeineCSPC Innovation Pharmaceutical Co., Ltd.ChinaR1-CEP 2003-156-Rev 0016.04.12Withdrawal2
CaffeineJilin Shulan Synthetic Pharmaceutical Co. Ltd.ChinaR1-CEP 2000-366-Rev 0122.02.12Suspension4
Calcium dobesilate monohydrateBajaj Healthcare LimitedIndiaR0-CEP 2010-209-Rev 0026.06.12Withdrawal2
Calcium glucoheptonateGlobal Calcium Private LimitedIndiaR0-CEP 2009-259-Rev 0006.12.12Withdrawal2
Calcium gluconateGlobal Calcium Private LimitedIndiaR1-CEP 2002-128-Rev 0006.12.12Withdrawal2
Calcium gluconate for injectionGlobal Calcium Private LimitedIndiaR1-CEP 2005-298-Rev 0006.12.12Withdrawal2
CarbamazepineBajaj Healthcare LimitedIndiaR1-CEP 2002-141-Rev 0001.07.13Withdrawal2
CarbamazepineAmoli Organics Priv Ltd.IndiaR1-CEP 1997-102-Rev 0222.06.12Suspension5
CarbidopaSmruthi Organics Ltd.IndiaR0-CEP 2006-138-Rev 0113.12.13Withdrawal2
CefaclorSurya Pharmaceuticals Ltd.IndiaR0-CEP 2009-136-Rev 0010.01.14Withdrawal3
Cefalexin monohydrateSurya Pharmaceuticals Ltd.IndiaR0-CEP 2010-140-Rev 0010.01.14Withdrawal3
CefiximeSurya Pharmaceuticals Ltd.IndiaR0-CEP 2007-314-Rev 0010.01.14Withdrawal3
Cefuroxime axetilSurya Pharmaceuticals Ltd.IndiaR0-CEP 2010-251-Rev 0010.01.14Withdrawal3
Chlorhexidine digluconate sodiumBajaj Healthcare LimitedIndiaR0-CEP 2005-076-Rev 0126.06.12Withdrawal2
Chlorobutanol hemihydratePolydrug Laboratories Pvt., Ltd.IndiaR0-CEP 2009-112-Rev 0007.05.15Suspension2
CholesterolMilliporeUSAR1-CEP 2003-043-Rev 0018.12.14Withdrawal3
CiclosporinTaishan City Chemical Pharm. Co., Ltd.ChinaR0-CEP 2006-223-Rev 0103.11.14Withdrawal2
Cilastatin sodium sterileZhuhai United Laboratories Co., Ltd.ChinaR0-CEP 2010-184-Rev 0113.05.15Suspension2
CimetidineWuxi Kaili Pharmaceutical Co., Ltd.ChinaR1-CEP 2002-008-Rev 0124.10.13Suspension5
CinnarizineFleming Laboratories Ltd.IndiaR0-CEP 2007-257-Rev 0006.12.13Withdrawal2
Ciprofloxacin hydrochlorideZhejiang Jingxin Pharmaceutical Co., Ltd.ChinaR1-CEP 2005-262-Rev 0012.05.14Restoration
Ciprofloxacin hydrochlorideSmruthi Organics Ltd.IndiaR0-CEP 2011-051-Rev 0013.12.13Withdrawal2
Clindamycin hydrochlorideSuzhou No.4 Pharmaceutical FactoryChinaR0-CEP 2005-287-Rev 0020.12.13Withdrawal2
Clindamycin phosphateSuzhou No.4 Pharmaceutical FactoryChinaR0-CEP 2007-250-Rev 0120.12.13Withdrawal2
Cloxacillin sodiumParabolic Drugs Ltd.IndiaR0-CEP 2010-350-Rev 0029.07.15Withdrawal2
ColchicineVital Laboratories Pvt. Ltd.IndiaR0-CEP 2011-016-Rev 0013.11.14Withdrawal3
Colistin sulfateZhejiang Apeloa Kangyu Bio-Pharm Co., Ltd.ChinaR1-CEP 2004-258-Rev 0024.07.15Restoration
Diclofenac SodiumHenan Dongtai Pharm Co., Ltd.ChinaR0-CEP 2006-304-Rev 0017.04.12Withdrawal2
Diclofenac SodiumAarti Drugs LimitedIndiaR1-CEP 2000-055-Rev 0116.04.12Suspension5
Dicloxacillin sodiumParabolic Drugs Ltd.IndiaR0-CEP 2011-052-Rev 0029.07.15Withdrawal2
DigoxinVital Laboratories Pvt. Ltd.IndiaR0-CEP 2009-281-Rev 0013.11.14Withdrawal3
DiosminShaanxi Huifeng Phramaceutical Ltd.ChinaR0-CEP 2009-032-Rev 0123.10.15Withdrawal2
DiosminElder Pharmaceuticals Ltd.IndiaR0-CEP 2011-303-Rev 0007.08.15Withdrawal3
DiosminHunan Yuantong Pharm Co., Ltd.ChinaR0-CEP 2011-177-Rev 0126.05.14Restoration
Diphenoxylate HydrochlorideRPG Life Sciences LimitedIndiaR0-CEP 2005-084-Rev 0020.12.11Suspension5
DiprophyllineCSPC Innovation Pharmaceutical Co., Ltd.ChinaR0-CEP 2009-033-Rev 0016.04.12Withdrawal2
DipyridamoleS.I.M.S. S.R.L.ItalyR1-CEP 2004-204-Rev 0009.02.15Restoration
Docetaxel, anhydrousFujian South Pharmaceutical Co., Ltd.ChinaR0-CEP 2011-320-Rev 0028.10.14Suspension2
Doxazosin mesilatePorton Pharmaceutical Ltd.ChinaR1-CEP 2007-244-Rev 0020.07.15Suspension1
Doxycycline hyclateHebei Dongfeng Pharmaceutical Co., LtdChinaR1-CEP 2004-163-Rev 0012.08.14Suspension2
Doxycycline monohydrateHebei Dongfeng Pharmaceutical Co., LtdChinaR1-CEP 2004-162-Rev 0012.08.14Suspension2
Ephedrine hydrochlorideChifeng Arker Pharmaceutical Technology Co., Ltd.ChinaR1-CEP 2002-193-Rev 0019.11.13Suspension5
ErythromycinMehta API Pvt. LtdIndiaR0-CEP 2009-267-Rev 0112.04.13Restoration
FentanylRusan Pharma Ltd.IndiaR0-CEP 2005-164-Rev 0013.11.12Suspension2
Fenticonazole nitrateOptimus Drugs Private Ltd.IndiaR0-CEP 2013-056-Rev 0219.10.15Suspension2
Ferrous fumaratePolydrug Laboratories Pvt., Ltd.IndiaR0-CEP 2010-147-Rev 0007.05.15Suspension2
Ferrous gluconateGlobal Calcium Private LimitedIndiaR0-CEP 2009-150-Rev 0006.12.12Suspension5
Flucloxacillin sodiumParabolic Drugs Ltd.IndiaR0-CEP 2005-064-Rev 0029.07.15Withdrawal2
FluconazolePolydrug Laboratories Pvt., Ltd.IndiaR0-CEP 2010-247-Rev 0007.05.15Suspension2
Flunarizine dihydrochlorideFleming Laboratories Ltd.IndiaR0-CEP 2004-142-Rev 0005.12.13Withdrawal2
FluorouracilNantong Haiers Pharm Co., Ltd.ChinaR1-CEP 2008-183-Rev 0030.03.15Withdrawal3
Folic AcidHebei Jiheng (Group) Pharmaceutical Co., Ltd.ChinaR0-CEP 2005-031-Rev 0020.06.14Suspension1
HaloperidolRPG Life Sciences LimitedIndiaR1-CEP 2003-206-Rev 0004.07.13Restoration
Heparin sodiumLeo Pharmaceutical Products Ltd. A/SDenmarkR1-CEP 2001-445-Rev 0220.02.13Suspension1
Imipenem monohydrateZhuhai United Laboratories Co., Ltd.ChinaR0-CEP 2010-163-Rev 0113.05.15Suspension2
IndometacinMacleods Phramaceuticals Ltd.IndiaR0-CEP 2009-314-Rev 0025.08.15Suspension3
IsoniazidCalyx Chemicals & Pharmaceuticals Ltd.IndiaR0-CEP 2008-108-Rev 0101.03.12Restoration
Isosorbide mononitrate, dilutedJ P Laboratories Priv. Ltd.IndiaR1-CEP 2002-104-Rev 0219.03.13Restoration
KetoprofenS.I.M.S. S.R.L.ItalyR1-CEP 2002-097-Rev 0309.02.15Restoration
Lactobionic acidGlobal Calcium Private LimitedIndiaR0-CEP 2009-258-Rev 0006.12.12Withdrawal2
Lactulose, liquidMilei GmbHGermanyR1-CEP 1998-021-Rev 0120.08.13Withdrawal3
LeflunomideFormosa Laboratories Inc.TaiwanR0-CEP 2009-035-Rev 0009.12.13Restoration
LidocaineS.I.M.S. S.R.L.ItalyR1-CEP 2004-156-Rev 0009.02.15Restoration
Lidocaine hydrochlorideS.I.M.S. S.R.L.ItalyR1-CEP 2001-014-Rev 0209.02.15Restoration
Lincomycin hydrochloridePfizer IncUSAR1-CEP 2005-284-Rev 0020.12.13Withdrawal2
Loperamide hydrochlorideFleming Laboratories Ltd.IndiaR0-CEP 2005-247-Rev 0106.12.13Withdrawal2
LovastatinKrebs Biochemicals & Industries Ltd.IndiaR1-CEP 2004-026-Rev 0017.11.15Restoration
Magnesium citrate, anhydrousGlobal Calcium Private LimitedIndiaR0-CEP 2009-151-Rev 0006.12.12Withdrawal2
Magnesium lactate dihydrateGlobal Calcium Private LimitedIndiaR0-CEP 2008-257-Rev 0006.12.12Withdrawal2
Mepivacaine hydrochlorideS.I.M.S. S.R.L.ItalyR0-CEP 2010-129-Rev 0009.02.15Restoration
MesalazineS.A. Ajinomoto Omnichem N.V.BelgiumR0-CEP 2009-098-Rev 0029.04.13Suspension1
Metformin HCLAarti Drugs LimitedIndiaR0-CEP 2005-072-Rev 0016.04.12Suspension5
Metformin hydrochlorideSmruthi Organics Ltd.IndiaR1-CEP 2005-232-Rev 0013.12.13Withdrawal2
Metoprolol succinateArevipharma GmbHGermanyR1-CEP 2005-223-Rev 0014.10.15Suspension1
Metoprolol succinatePharmaceutical Works Polpharma S.A.PolandR0-CEP 2011-312-Rev 0007.05.15Suspension2
Metoprolol succinatePolydrug Laboratories Pvt., Ltd.IndiaR0-CEP 2009-170-Rev 0107.05.15Suspension2
Metoprolol tartratePolydrug Laboratories Pvt., Ltd.IndiaR0-CEP 2009-152-Rev 0107.05.15Suspension2
Metoprolol tartratePharmaceutical Works Polpharma S.A.PolandR0-CEP 2011-304-Rev 0007.05.15Suspension2
Metoprolol tartrateS.I.M.S. S.R.L.ItalyR1-CEP 2004-087-Rev 0009.02.15Restoration
MetronidazoleHEC Pharm CoChinaR1-CEP 2005-002-Rev 0010.10.14Suspension1
MetronidazoleTianjin Zhongan Pharmaceutical Co., Ltd.ChinaR1-CEP 2002-119-Rev 0014.01.13Withdrawal3
Naltrexone hydrochlorideRusan Pharma Ltd.IndiaR0-CEP 2008-167-Rev 0013.11.12Suspension2
NifuroxazideSuzhou No.5 Pharmaceutical Factory Co., Ltd.ChinaR0-CEP 2006-074-Rev 0020.03.14Withdrawal3
NitrofurantoinJinan Jinda Pharmaceutical Chemistry Co., Ltd.ChinaR0-CEP 2011-240-Rev 0114.08.15Suspension2
NorfloxacinSmruthi Organics Ltd.IndiaR1-CEP 2001-409-Rev 0213.12.13Withdrawal2
OxaliplatinDesynth SA ARArgentiniaR0-CEP 2005-158-Rev 0020.04.12Withdrawal3
Oxybutynin hydrochlorideWockhardt Ltd.IndiaR1-CEP 2003-020-Rev 0316.06.14Suspension2
Oxytetracycline dihydrateHuashu Pharmaceutical Corp.ChinaR1-CEP 2002-211-Rev 0026.10.12Restoration
Oxytetracycline dihydrateShandong Jinyang Pharmaceutical Co., Ltd.ChinaR0-CEP 2004-177-Rev 0001.06.12Withdrawal3
Oxytetracycline hydrochlorideDafeng - Huashu Pharmaceutical Company LimitedChinaR1-CEP 2002-070-Rev 0011.03.13Restoration
Oxytetracycline hydrochlorideJiangxi Guoyao Pharmaceutical Ltd.ChinaR1-CEP 2001-125-Rev 0026.10.12Restoration
Oxytetracycline hydrochlorideShandong Jinyang Pharmaceutical Co., Ltd.ChinaR0-CEP 2008-165-Rev 0001.06.12Withdrawal3
OxytocinShanghai Soho-Yiming Pharmaceuticals Co., Ltd.ChinaR0-CEP 2011-003-Rev 0013.02.15Suspension1
ParacetamolWeistar Industry LimitedChinaR0-CEP 2006-156-Rev 0016.04.13Withdrawal2
Phenoxymethylpenicillin potassiumNorth China Pharmaceutical Co., Ltd.ChinaR0-CEP 2006-019-Rev 0004.11.13Withdrawal2
Pilocarpine hydrochlorideSourcetech Quimica LtdaBrazilR1-CEP 1997-034-Rev 0311.03.13Restoration
Pilocarpine nitrateSourcetech Quimica LtdaBrazilR1-CEP 2002-202-Rev 0111.03.13Restoration
PivampicillinParabolic Drugs Ltd.IndiaR0-CEP 2009-295-Rev 0029.07.15Withdrawal2
Potassium clavulanate sterileZhuhai United Laboratories Co., Ltd.ChinaR0-CEP 2013-133-Rev 0013.05.15Suspension2
Povidone, iodinatedHangzhou Sunflower Technology Dev Co., Ltd.ChinaR0-CEP 2009-166-Rev 0019.03.15Withdrawal2
Protamine sulfateBiochem CorporationJapanR1-CEP 2000-162-Rev 0005.07.13Withdrawal2
Pseudoephedrine hydrochlorideChifeng Arker Pharmaceutical Technology Co., Ltd.ChinaR1-CEP 2002-217-Rev 0219.11.13Suspension5
PyrazinamideDIFC Co. Ltd.South KoreaR1-CEP 2001-197-Rev 0109.04.13Withdrawal3
PyrazinamideLinaria Chemicals Ltd.ThailandR1-CEP 1998-070-Rev 0221.01.13Withdrawal3
Quinine hydrochlorideVital Laboratories Pvt. Ltd.IndiaR0-CEP 2005-114-Rev 0113.11.14Withdrawal3
Quinine hydrochlorideAanjaneya Lifecare Ltd.IndiaR0-CEP 2010-069-Rev 0008.02.12Withdrawal2
Quinine sulfateVital Laboratories Pvt. Ltd.IndiaR0-CEP 2005-117-Rev 0113.11.14Withdrawal3
Quinine sulfateAanjaneya Lifecare Ltd.IndiaR0-CEP 2009-387-Rev 0008.02.12Withdrawal2
ReserpineVital Laboratories Pvt. Ltd.IndiaR0-CEP 2010-041-Rev 0013.11.14Withdrawal3
RifampicinZhengzhou Minzhong Pharmaceutical Co. Ltd.ChinaR0-CEP 2004-295-Rev 0023.01.13Withdrawal3
RisperidoneRPG Life Sciences LimitedIndiaR1-CEP 2004-135-Rev 0104.07.13Restoration
Ropivacaine hydrochloride monohydrateSynteco S.p.A.ItalyR0-CEP 2011-169-Rev 0010.04.15Suspension1
SimvastatinKrebs Biochemicals & Industries Ltd.IndiaR1-CEP 2004-051-Rev 0117.11.15Restoration
SimvastatinTopfond Pharm Co., Ltd.ChinaR1-CEP 2006-232-Rev 0128.04.15Suspension1
SimvastatinZhejiang Jingxin Pharmaceutical Co., Ltd.ChinaR1-CEP 2005-300-Rev 0012.05.14Suspension
Simvastatin BHTTopfond Pharm Co., Ltd.ChinaR0-CEP 2011-323-Rev 0228.04.15Suspension1
Simvastatin with 0.2% butylated hydroxy anisoleKrebs Biochemicals & Industries Ltd.IndiaR0-CEP 2007-210-Rev 0117.11.15Restoration
Sodium alendronate trihydrateShijiazhuang Pharmaceutical Group, Huasheng Pharma Co., Ltd.ChinaR1-CEP 2006-189-Rev 0007.08.15Withdrawal3
Stanozolol MicronisedEdmond Pharma S.R.L.ItalyR1-CEP 2002-222-Rev 0120.04.12Suspension1
SulpirideJiangsu Tasly Diyi Pharmaceutical Co., Ltd.ChinaR1-CEP 2005-077-Rev 0120.07.15Suspension1
Tamoxifen citrateArevipharma GmbHGermanyR1-CEP 2005-197-Rev 0114.10.15Suspension1
TelmisartanWatson Pharma Private Ltd.IndiaR0-CEP 2010-261-Rev 0013.12.13Withdrawal2
TheobromineCSPC Innovation Pharmaceutical Co., Ltd.ChinaR0-CEP 2010-168-Rev 0016.04.12Withdrawal2
TheophyllineBakul Aromatics and Chemicals LtdIndiaR1-CEP 1998-094-Rev 0109.01.14Withdrawal3
TheophyllineCSPC Innovation Pharmaceutical Co., Ltd.ChinaR0-CEP 2006-087-Rev 0116.04.12Withdrawal2
TheophyllineJilin Shulan Synthetic Pharmaceutical Co. Ltd.ChinaR1-CEP 2004-139-Rev 0022.02.12Suspension4
Theophylline-ethylenediamine anhydrousCSPC Innovation Pharmaceutical Co., Ltd.ChinaR0-CEP 2007-345-Rev 0116.04.12Withdrawal2
Theophylline-ethylenediamine anhydrousJilin Shulan Synthetic Pharmaceutical Co. Ltd.ChinaR1-CEP 2004-140-Rev 0022.02.12Suspension4
Ticlopidine hydrochlorideS.I.M.S. S.R.L.ItalyR1-CEP 2002-106-Rev 0109.02.15Restoration
Ticlopidine hydrochlorideRPG Life Sciences LimitedIndiaR1-CEP 2003-066-Rev 0004.07.13Restoration
TriflusalEstechpharma Co., Ltd.South KoreaR1-CEP 2004-195-Rev 0111.04.13Withdrawal2
Trimetazidine dihydrochlorideSharon Bio-Medicine LtdIndiaR0-CEP 2010-075-Rev 0227.06.14Restoration
Trimetazidine dihydrochlorideNivedita Chemicals Pvt. Ltd.IndiaR0-CEP 2007-245-Rev 0222.07.13Restoration
TrimethoprimPunjab Chemicals and Crop Protection Ltd.IndiaR1-CEP 1999-037-Rev 0216.10.15Restoration
TroxerutinErgypharmFranceR0-CEP 2006-153-Rev 0120.12.11Suspension4
Venlafaxine hydrochlorideAmoli Organics Priv Ltd.IndiaR0-CEP 2008-092-Rev 0113.05.14Restoration
ZopicloneCalyx Chemicals & Pharmaceuticals Ltd.IndiaR1-CEP 2001-203-Rev 0101.03.12Restoration

Keys

  1. By EDQM, upon request from the holder, due to a temporary inability to produce the API under the approved conditions
  2. By EDQM, as a result of an inspection of the manufacturing site(s)
  3. By EDQM, due to a failure to fulfill the requirements of the CEP procedure with regards to updating the application and complying with GMP
  4. By EDQM, due to a failure to comply with a declaration of willingness to be inspected and/or to operate according to EU GMP (e.g. refusal, of inspection, reconstruction/restoration of site(s), to achieve GMP level, and temporary closure)
  5. By EDQM, following inspection of the manufacturing site(s)

Among others, blue audits at/for:

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hennig-arzneimittel-logo
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lomapharm-logo
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