Übersicht aktueller CEP-Suspendierungen, Entzüge und Wiederherstellungen

Die Mehrzahl der in Europa zugelassenen Arzneimittel enthält bekannte Wirkstoffe, deren Qualität in einer Monografie des Europäischen Arzneibuchs festgelegt ist. Für solche Arzneimittel besteht die Möglichkeit, im Rahmen des Zulassungsantrags die Wirkstoffqualität durch ein "Certificate of Suitability to the Monographs of the European Pharmacopoeia" (kurz: CEP) der EDQM zu belegen.

Die EDQM führt risikobasiert Inspektionen von Herstellungsstätten durch, um die GMP- und Dossierkonformität der Wirkstoffherstellung zu prüfen. In der Folge kann es durch verschiedene Gründe zu einer CEP-Suspendierung oder gar einem CEP-Entzug kommen. Die folgende Liste aktueller Inspetionsergebnisse beruht auf der von der EDQM bereitgestellten Datenbank. Wir übernehmen keine Gewähr für Richtigkeit oder Vollständigkeit dieser Daten.

Das Vorliegen eines gültigen CEP-Zertifikates entbindet Arzneimittelhersteller nicht von der Pflicht, ihre Wirkstofflieferanten gründlich und kompetent zu überwachen bzw. überwachen zu lassen. Der API-Audit-Service von Diapharm übernimmt das für Sie – sprechen Sie uns an!

Photo:  Eimear Schulte
Eimear Schulte
Senior Consultant
Photo:  Judith Gorschlüter
Judith Gorschlüter
Associate

CEP-Zertifikate: Aktuelle Inspektionsergebnisse nach Wirkstoff








Ausgewählte Einträge:

INGREDIENT MANUFACTURER COUNTRY CEP NO. DATE ACTION REASON
Acamprosate calcium Estechpharma Co., Ltd. South Korea R1-CEP 2001-160-Rev 02 11.04.13 WITHDRAWN BY EDQM 2
Acarbose Zhejiang Hisun Pharmaceutical Co., Ltd. China R1-CEP 2006-144-Rev 00 28.10.16 SUSPENDED
Aceclofenac Estechpharma Co., Ltd. South Korea R1-CEP 2004-006-Rev 00 11.04.13 WITHDRAWN BY EDQM 2
Acetylsalicylic acid Chimprod SA Romania R1-CEP 1994-014-Rev 02 20.12.11 WITHDRAWN BY EDQM
Acetylsalicylic acid Industria Quimica Andina & Cia. S.A. Colombia R0-CEP 2006-195-Rev 00 20.04.12 WITHDRAWN BY EDQM 3
Acetylsalicylic acid Crystals 7010/7011, fines 7012, granules 7017/7018, granular powder 7028, PR powder 7029 Alta Laboratories Ltd India R1-CEP 2000-013-Rev 01 25.05.09 WITHDRAWN BY EDQM
Adenosine Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2013-044-Rev 00 28.10.16 SUSPENDED
Allopurinol Shanghai OSD Co., Ltd. China R0-CEP 2004-189-Rev 02 04.10.10 WITHDRAWN BY EDQM
Ambroxol hydrochloride KORES (INDIA) LIMITED India R0-CEP 2013-115-Rev 01 10.04.17 SUSPENDED 2
Ambroxol hydrochloride OLON S.P.A. IT Italy R0-CEP 2015-012-Rev 00 10.04.17 SUSPENDED 2
Amlodipine besilate Smruthi Organics Ltd. India R0-CEP 2007-285-Rev 01 13.12.13 WITHDRAWN BY EDQM
Amoxicillin sodium sterile Zhuhai United Laboratories Co., Ltd. China R0-CEP 2013-125-Rev 01 13.05.15 SUSPENDED 2
Amoxicillin trihydrate Parabolic Drugs Ltd. India R1-CEP 2004-266-Rev 01 29.07.15 WITHDRAWN BY EDQM 2
Amoxicillin trihydrate Powder, compacted and micronised powder KDL Biotech Limited India R0-CEP 1997-129-Rev 00 11.03.11 WITHDRAWN BY EDQM
Ampicillin trihydrate Parabolic Drugs Ltd. India R0-CEP 2011-083-Rev 00 29.07.15 WITHDRAWN BY EDQM 2
Ampicillin, anhydrous Parabolic Drugs Ltd. India R0-CEP 2011-090-Rev 00 29.07.15 WITHDRAWN BY EDQM 2
Articaine hydrochloride S.I.M.S. S.R.L. Italy R0-CEP 2009-137-Rev 00 09.02.15 RESTORED
Ascorbic acid BASF SE Germany R2-CEP 1994-001-Rev 01 24.01.12 WITHDRAWN BY EDQM
Ascorbic acid HEBEI WELCOME PHARMACEUTICAL CO. China R1-CEP 2008-185-Rev 00 26.08.14 SUSPENDED 1
Atorvastatin calcium trihydrate Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2013-339-Rev 00 28.10.16 SUSPENDED
Atropine sulfate RESONANCE LABORATORIES PVT. LTD. India R0-CEP 2015-323-Rev 00 30.05.17 SUSPENDED 1
Azathioprine RPG Life Sciences Limited India R1-CEP 2001-341-Rev 02 04.07.13 RESTORED
Bacampicillin hydrochloride Parabolic Drugs Ltd. India R0-CEP 2011-106-Rev 00 29.07.15 WITHDRAWN BY EDQM 2
Benzylpenicillin, procaine North China Pharmaceutical Group Semisyntech Co., Ltd. China R1-CEP 2004-001-Rev 01 03.03.15 WITHDRAWN BY EDQM 2
Benzylpenicillin, procaine North China Pharmaceutical Group Semisyntech Co., Ltd. China R1-CEP 2004-017-Rev 01 03.03.15 WITHDRAWN BY EDQM 2
Bicalutamide Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2013-195-Rev 00 28.10.16 SUSPENDED
Bleomycin Sulfate Alternative process Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2012-197-Rev 01 28.10.16 SUSPENDED
Bupivacaine hydrochloride S.I.M.S. S.R.L. Italy R1-CEP 2001-013-Rev 01 09.02.15 RESTORED
Buprenorphine Rusan Pharma Ltd. India R0-CEP 2007-065-Rev 00 13.11.12 SUSPENDED 2
Buprenorphine hydrochloride Rusan Pharma Ltd. India R1-CEP 2001-278-Rev 02 13.11.12 WITHDRAWN BY EDQM
Caffeine CSPC Innovation Pharmaceutical Co., Ltd. China R1-CEP 2003-156-Rev 00 16.04.12 WITHDRAWN BY EDQM 2
Caffeine Tianjin Zhongan Pharmaceutical Co., Ltd. China R0-CEP 2005-116-Rev 01 14.01.13 WITHDRAWN BY EDQM 3
Calcium dobesilate monohydrate Bajaj Healthcare Limited India R0-CEP 2010-209-Rev 00 26.06.12 WITHDRAWN BY EDQM 2
Calcium glucoheptonate Global Calcium Private Limited India R0-CEP 2009-259-Rev 00 06.12.12 WITHDRAWN BY EDQM 2
Calcium gluconate Global Calcium Private Limited India R1-CEP 2002-128-Rev 00 06.12.12 WITHDRAWN BY EDQM 2
Calcium gluconate for injection Global Calcium Private Limited India R1-CEP 2005-298-Rev 00 06.12.12 WITHDRAWN BY EDQM 2
Capecitabine Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2015-009-Rev 00 28.10.16 SUSPENDED
Carbamazepine Amoli Organics Priv Ltd. India R1-CEP 1997-102-Rev 02 22.06.12 SUSPENDED 5
Carbamazepine Bajaj Healthcare Limited India R1-CEP 2002-141-Rev 00 01.07.13 WITHDRAWN BY EDQM 2
Carbidopa Smruthi Organics Ltd. India R0-CEP 2006-138-Rev 01 13.12.13 WITHDRAWN BY EDQM 2
Cefaclor Surya Pharmaceuticals Ltd. India R0-CEP 2009-136-Rev 00 10.01.14 WITHDRAWN BY EDQM 3
Cefalexin monohydrate Surya Pharmaceuticals Ltd. India R0-CEP 2010-140-Rev 00 10.01.14 WITHDRAWN BY EDQM 3
Cefixime Surya Pharmaceuticals Ltd. India R0-CEP 2007-314-Rev 00 10.01.14 WITHDRAWN BY EDQM 3
Cefixime Dhanuka Laboratories Ltd. India R1-CEP 2003-014-Rev 02 02.06.14 WITHDRAWN BY EDQM 2
Ceftazidime pentahydrate with sodium carbonate for injection ANTIBIOTICOS DO BRASIL LTDA. Brazil R0-CEP 2010-026-Rev 01 16.03.17 SUSPENDED 2
Ceftriaxone sodium sterile Kukje Pharmaceutical Ind. Co., Ltd. South Korea R1-CEP 2000-017-Rev 00 13.07.10 WITHDRAWN BY EDQM
Cefuroxime axetil Surya Pharmaceuticals Ltd. India R0-CEP 2010-251-Rev 00 10.01.14 WITHDRAWN BY EDQM 3
Cefuroxime axetil Dhanuka Laboratories Ltd. India R0-CEP 2011-173-Rev 00 18.03.13 WITHDRAWN BY EDQM 2
Cefuroxime sodium Sterile Kukje Pharmaceutical Ind. Co., Ltd. South Korea R0-CEP 2004-050-Rev 00 13.07.10 WITHDRAWN BY EDQM
Celecoxib Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2014-340-Rev 00 28.10.16 SUSPENDED
Chlorhexidine digluconate sodium Bajaj Healthcare Limited India R0-CEP 2005-076-Rev 01 26.06.12 WITHDRAWN BY EDQM 2
Chlorobutanol hemihydrate Polydrug Laboratories Pvt., Ltd. India R0-CEP 2009-112-Rev 00 26.10.16 WITHDRAWN BY EDQM
Chlorpropamide Albert David Ltd India R1-CEP 2000-020-Rev 01 18.02.11 WITHDRAWN BY EDQM
Cholesterol Millipore USA R1-CEP 2003-043-Rev 00 18.12.14 WITHDRAWN BY EDQM 3
Ciclosporin CONCORD BIOTECH LIMITED India R1-CEP 2010-214-Rev 01 31.10.17 RESTORED
Ciclosporin Taishan City Chemical Pharm. Co., Ltd. China R0-CEP 2006-223-Rev 01 03.11.14 WITHDRAWN BY EDQM 2
Cilastatin sodium sterile Zhuhai United Laboratories Co., Ltd. China R0-CEP 2010-184-Rev 01 13.05.15 SUSPENDED 2
Cimetidine Wuxi Kaili Pharmaceutical Co., Ltd. China R1-CEP 2002-008-Rev 01 15.12.15 WITHDRAWN BY EDQM
Cinnarizine Fleming Laboratories Ltd. India R0-CEP 2007-257-Rev 00 06.12.13 WITHDRAWN BY EDQM 2
Ciprofloxacin hydrochloride Smruthi Organics Ltd. India R0-CEP 2011-051-Rev 00 13.12.13 WITHDRAWN BY EDQM 2
Cladribine Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2012-132-Rev 00 28.10.16 SUSPENDED
Clindamycin hydrochloride Suzhou No.4 Pharmaceutical Factory China R0-CEP 2005-287-Rev 00 20.12.13 WITHDRAWN BY EDQM 2
Clindamycin phosphate Suzhou No.4 Pharmaceutical Factory China R0-CEP 2007-250-Rev 01 20.12.13 WITHDRAWN BY EDQM 2
Cloxacillin sodium KDL Biotech Limited India R0-CEP 1997-131-Rev 01 14.03.11 WITHDRAWN BY EDQM
Cloxacillin sodium Parabolic Drugs Ltd. India R0-CEP 2010-350-Rev 00 29.07.15 WITHDRAWN BY EDQM 2
Colchicine Sanmar Speciality Chemicals Limited India R1-CEP 2002-062-Rev 01 18.11.09 SUSPENDED 1
Colchicine Vital Laboratories Pvt. Ltd. India R0-CEP 2011-016-Rev 00 13.11.14 WITHDRAWN BY EDQM 3
Colistin sulfate Zhejiang Apeloa Kangyu Bio-Pharm Co., Ltd. China R1-CEP 2004-258-Rev 00 24.07.15 RESTORED
Cyclophosphamide Zhejiang Hisun Pharmaceutical Co., Ltd. China R1-CEP 2005-279-Rev 01 28.10.16 SUSPENDED
Cytarabine Zhejiang Hisun Pharmaceutical Co., Ltd. China R1-CEP 2001-390-Rev 03 28.10.16 SUSPENDED
Daunorubicin Hydrochloride Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2012-380-Rev 00 28.10.16 SUSPENDED
Diclofenac Sodium Henan Dongtai Pharm Co., Ltd. China R0-CEP 2006-304-Rev 00 17.04.12 WITHDRAWN BY EDQM 2
Diclofenac sodium Ningbo Smart Pharmaceutical Co., Ltd. China R1-CEP 1999-075-Rev 01 18.02.11 WITHDRAWN BY EDQM
Dicloxacillin sodium Parabolic Drugs Ltd. India R0-CEP 2011-052-Rev 00 29.07.15 WITHDRAWN BY EDQM 2
Digoxin Vital Laboratories Pvt. Ltd. India R0-CEP 2009-281-Rev 00 13.11.14 WITHDRAWN BY EDQM 3
Diosmin Chengdu Okay Pharmaceutical Co., Ltd. China R0-CEP 2012-359-Rev 02 14.03.17 RESTORED
Diosmin Elder Pharmaceuticals Ltd. India R0-CEP 2011-303-Rev 00 07.08.15 WITHDRAWN BY EDQM 3
Diosmin Hunan Yuantong Pharm Co., Ltd. China R0-CEP 2011-177-Rev 01 26.05.14 RESTORED
Diosmin Shaanxi Huifeng Phramaceutical Ltd. China R0-CEP 2009-032-Rev 01 23.10.15 WITHDRAWN BY EDQM 2
Diprophylline CSPC Innovation Pharmaceutical Co., Ltd. China R0-CEP 2009-033-Rev 00 16.04.12 WITHDRAWN BY EDQM 2
Dipyridamole S.I.M.S. S.R.L. Italy R1-CEP 2004-204-Rev 00 09.02.15 RESTORED
Docetaxel trihydrate Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2013-261-Rev 00 28.10.16 SUSPENDED
Doxazosin mesilate Porton Pharmaceutical Ltd. China R1-CEP 2007-244-Rev 00 20.07.15 SUSPENDED 1
Doxorubicin Hydrochloride Zhejiang Hisun Pharmaceutical Co., Ltd. China R1-CEP 1999-151-Rev 05 28.10.16 SUSPENDED
Doxorubicin Hydrochloride Fermentation process Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2013-262-Rev 00 28.10.16 SUSPENDED
Doxycycline hyclate KUNSHAN CHEMICAL AND PHARMACEUTICAL FACTORY China R0-CEP 2003-225-Rev 00 02.07.08 WITHDRAWN BY EDQM
Doxycycline hyclate Shanghai International Pharmaceutical Co., Ltd. China R2-CEP 1992-018-Rev 00 22.10.10 WITHDRAWN BY EDQM
Doxycycline monohydrate KUNSHAN CHEMICAL AND PHARMACEUTICAL FACTORY China R0-CEP 2003-226-Rev 00 02.07.08 WITHDRAWN BY EDQM
Doxycycline monohydrate Shanghai International Pharmaceutical Co., Ltd. China R1-CEP 1996-064-Rev 04 22.10.10 WITHDRAWN BY EDQM
Enalapril maleate GULF OIL Corporation Limited India R0-CEP 2005-206-Rev 00 13.10.10 WITHDRAWN BY EDQM
Enoxaparin sodium Dongying Tiandong Pharmaceutical Co., Ltd. China R1-CEP 2005-258-Rev 01 12.04.16 SUSPENDED
Ephedrine hydrochloride Xinjiang Heshuo Ephedrine Product Co., Ltd China R0-CEP 2004-152-Rev 00 07.03.11 WITHDRAWN BY EDQM
Epirubicin hydrochloride Zhejiang Hisun Pharmaceutical Co., Ltd. China R1-CEP 2000-077-Rev 05 28.10.16 SUSPENDED
Erythromycin Anuh Pharma Ltd India R1-CEP 2005-205-Rev 03 17.02.17 RESTORED
Erythromycin Mehta API Pvt. Ltd India R0-CEP 2009-267-Rev 01 12.04.13 RESTORED
Erythromycin ethylsuccinate AbbVie Inc. US 60064 North Chicago USA R1-CEP 1999-138-Rev 03 13.04.17 WITHDRAWN BY EDQM 3
Erythromycin ethylsuccinate Anuh Pharma Ltd India R1-CEP 2007-235-Rev 01 02.05.17 RESTORED
Erythromycin stearate AbbVie Inc. US 60064 North Chicago USA R1-CEP 2002-233-Rev 01 13.04.17 WITHDRAWN BY EDQM 3
Ethinylestradiol Jenapharm GmbH & Co KG Germany R2-CEP 1996-014-Rev 01 11.04.08 WITHDRAWN BY EDQM
Fentanyl Rusan Pharma Ltd. India R0-CEP 2005-164-Rev 00 13.11.12 WITHDRAWN BY EDQM
Fenticonazole nitrate Optimus Drugs Private Ltd. India R0-CEP 2013-056-Rev 02 19.10.15 SUSPENDED 2
Ferrous fumarate Polydrug Laboratories Pvt., Ltd. India R0-CEP 2010-147-Rev 00 26.10.16 WITHDRAWN BY EDQM
Flucloxacillin sodium Parabolic Drugs Ltd. India R0-CEP 2005-064-Rev 00 29.07.15 WITHDRAWN BY EDQM 2
Flucloxacillin sodium Process II Parabolic Drugs Ltd. India R0-CEP 2010-311-Rev 00 29.07.15 WITHDRAWN BY EDQM
Fluconazole Polydrug Laboratories Pvt., Ltd. India R0-CEP 2010-247-Rev 00 26.10.16 WITHDRAWN BY EDQM
Fludarabine phosphate Zhejiang Hisun Pharmaceutical Co., Ltd. China R1-CEP 2006-076-Rev 00 28.10.16 SUSPENDED
Flunarizine dihydrochloride Fleming Laboratories Ltd. India R0-CEP 2004-142-Rev 00 05.12.13 WITHDRAWN BY EDQM 2
Fluorouracil Nantong Haiers Pharm Co., Ltd. China R1-CEP 2008-183-Rev 00 30.03.15 WITHDRAWN BY EDQM 3
Fluvastatin sodium Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2012-063-Rev 00 28.10.16 SUSPENDED
Folic Acid Hebei Jiheng (Group) Pharmaceutical Co., Ltd. China R0-CEP 2005-031-Rev 00 20.06.14 SUSPENDED 1
Gemcitabine hydrochloride Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2011-117-Rev 01 28.10.16 SUSPENDED
Glimepiride KORES (INDIA) LIMITED India R0-CEP 2015-224-Rev 00 10.04.17 SUSPENDED 2
Glucose CSPC SHENGXUE GLUCOSE CO., LTD. China R1-CEP 2004-274-Rev 03 09.08.16 WITHDRAWN BY EDQM
Granisetron hydrochloride Zhejiang Hisun Pharmaceutical Co., Ltd. China R1-CEP 2006-285-Rev 00 28.10.16 SUSPENDED
Haloperidol RPG Life Sciences Limited India R1-CEP 2003-206-Rev 00 04.07.13 RESTORED
Imipenem monohydrate Zhuhai United Laboratories Co., Ltd. China R0-CEP 2010-163-Rev 01 13.05.15 SUSPENDED 2
Indometacin Macleods Phramaceuticals Ltd. India R0-CEP 2009-314-Rev 00 25.08.15 SUSPENDED 3
Isoniazid Calyx Chemicals & Pharmaceuticals Ltd. India R0-CEP 2008-108-Rev 01 01.03.12 RESTORED
Isosorbide mononitrate, diluted J P Laboratories Priv. Ltd. India R1-CEP 2002-104-Rev 02 26.04.16 WITHDRAWN BY EDQM
Isosorbide mononitrate, diluted 70% and 80% Calao SRL Italy R0-CEP 2001-329-Rev 00 06.01.04 WITHDRAWN BY EDQM
Ivermectin Zhejiang Hisun Pharmaceutical Co., Ltd. China R1-CEP 1999-176-Rev 03 28.10.16 SUSPENDED
Ketoprofen S.I.M.S. S.R.L. Italy R1-CEP 2002-097-Rev 03 09.02.15 RESTORED
Lactobionic acid Global Calcium Private Limited India R0-CEP 2009-258-Rev 00 06.12.12 WITHDRAWN BY EDQM 2
Lactulose, liquid Milei GmbH Germany R1-CEP 1998-021-Rev 01 20.08.13 WITHDRAWN BY EDQM 3
Lansoprazole ENAL DRUGS PRIVATE LIMITED India R1-CEP 2008-204-Rev 01 24.04.18 RESTORED 4
Leflunomide Formosa Laboratories Inc. Taiwan R0-CEP 2009-035-Rev 00 09.12.13 RESTORED
Letrozole Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2010-331-Rev 01 28.10.16 SUSPENDED
Levonorgestrel Jenapharm GmbH & Co KG Germany R1-CEP 1996-031-Rev 02 11.04.08 WITHDRAWN BY EDQM
Lidocaine S.I.M.S. S.R.L. Italy R1-CEP 2004-156-Rev 00 09.02.15 RESTORED
Lidocaine hydrochloride S.I.M.S. S.R.L. Italy R1-CEP 2001-014-Rev 02 09.02.15 RESTORED
Lincomycin hydrochloride NANYANG PUKANG PHARMACEUTICAL CO., LTD. China R0-CEP 2013-114-Rev 00 26.11.15 SUSPENDED
Lindane Kanoria Chemicals & Industries Limited India R0-CEP 2004-290-Rev 00 28.04.09 WITHDRAWN BY EDQM
Loperamide hydrochloride Fleming Laboratories Ltd. India R0-CEP 2005-247-Rev 01 06.12.13 WITHDRAWN BY EDQM 2
Losartan potassium Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2012-209-Rev 00 02.11.16 RESTORED
Lovastatin CONCORD BIOTECH LIMITED India R1-CEP 2004-115-Rev 02 31.10.17 RESTORED
Lovastatin KREBS BIOCHEMICALS & INDUSTRIES LIMITED India R1-CEP 2004-026-Rev 02 25.08.17 RESTORED
Lovastatin Zhejiang Hisun Pharmaceutical Co., Ltd. China R1-CEP 2001-406-Rev 03 28.10.16 SUSPENDED
Magnesium citrate, anhydrous Global Calcium Private Limited India R0-CEP 2009-151-Rev 00 06.12.12 WITHDRAWN BY EDQM 2
Magnesium lactate dihydrate Global Calcium Private Limited India R0-CEP 2008-257-Rev 00 06.12.12 WITHDRAWN BY EDQM 2
Mefenamic acid Ningbo Smart Pharmaceutical Co., Ltd. China R1-CEP 2000-043-Rev 01 18.02.11 WITHDRAWN BY EDQM
Mepivacaine hydrochloride S.I.M.S. S.R.L. Italy R0-CEP 2010-129-Rev 00 09.02.15 RESTORED
Metamizole sodium monohydrate VANI PHARMA LABS LIMITED India R1-CEP 2001-220-Rev 01 26.02.10 WITHDRAWN BY EDQM
Metformin hydrochloride Smruthi Organics Ltd. India R1-CEP 2005-232-Rev 00 13.12.13 WITHDRAWN BY EDQM 2
Methotrexate Zhejiang Hisun Pharmaceutical Co., Ltd. China R1-CEP 2007-357-Rev 01 28.10.16 SUSPENDED
Metoprolol succinate Arevipharma GmbH Germany R1-CEP 2005-223-Rev 00 14.10.15 SUSPENDED 1
Metoprolol succinate Polydrug Laboratories Pvt., Ltd. India R0-CEP 2009-170-Rev 01 07.05.15 WITHDRAWN BY EDQM
Metoprolol tartrate Polydrug Laboratories Pvt., Ltd. India R0-CEP 2009-152-Rev 01 26.10.16 WITHDRAWN BY EDQM
Metoprolol tartrate S.I.M.S. S.R.L. Italy R1-CEP 2004-087-Rev 00 09.02.15 RESTORED
Metronidazole HUBEI HONGYUAN PHARMACEUTICAL TECHNOLOGY CO., LTD. China R1-CEP 2007-309-Rev 02 08.06.18 RESTORED 4
Metronidazole Tianjin Zhongan Pharmaceutical Co., Ltd. China R1-CEP 2002-119-Rev 00 14.01.13 WITHDRAWN BY EDQM 3
Mitomycin Alternative process Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2012-013-Rev 01 28.10.16 SUSPENDED
Mupirocin CONCORD BIOTECH LIMITED India R0-CEP 2015-041-Rev 01 31.10.17 RESTORED
Mupirocin calcium CONCORD BIOTECH LIMITED India R0-CEP 2015-119-Rev 01 31.10.17 RESTORED
Mycophenolate mofetil CONCORD BIOTECH LIMITED India R1-CEP 2009-361-Rev 02 31.10.17 RESTORED
Naltrexone hydrochloride Rusan Pharma Ltd. India R0-CEP 2008-167-Rev 00 13.11.12 WITHDRAWN BY EDQM
Netilmicin sulfate Zhejiang Zhenyuan Pharmaceutical Co., Ltd. China R1-CEP 2006-036-Rev 00 29.09.17 WITHDRAWN BY EDQM 3
Nifuroxazide Suzhou No.5 Pharmaceutical Factory Co., Ltd. China R0-CEP 2006-074-Rev 00 20.03.14 WITHDRAWN BY EDQM 3
Nitrofurantoin Jinan Jinda Pharmaceutical Chemistry Co., Ltd. China R0-CEP 2011-240-Rev 01 21.07.16 WITHDRAWN BY EDQM
Norfloxacin Smruthi Organics Ltd. India R1-CEP 2001-409-Rev 02 13.12.13 WITHDRAWN BY EDQM 2
Oxaliplatin Desynth SA AR Argentinia R0-CEP 2005-158-Rev 00 20.04.12 WITHDRAWN BY EDQM 3
Oxaliplatin Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2014-037-Rev 00 28.10.16 SUSPENDED
Oxybutynin hydrochloride RESONANCE LABORATORIES PVT. LTD. India R1-CEP 2003-112-Rev 02 30.05.17 SUSPENDED 1
Oxytetracycline dihydrate Huashu Pharmaceutical Corporation China R1-CEP 2002-211-Rev 00 20.03.17 WITHDRAWN BY EDQM 3
Oxytetracycline hydrochloride Dafeng - Huashu Pharmaceutical Company Limited China R1-CEP 2002-070-Rev 00 23.05.17 SUSPENDED 3
Oxytetracycline hydrochloride Dafeng - Huashu Pharmaceutical Company Limited China R1-CEP 2002-070-Rev 00 23.05.17 SUSPENDED 3
Oxytetracycline hydrochloride JIANGXI GUOYAO PHARMACEUTICAL LIMITED LIABILITY COMPANY China R1-CEP 2001-125-Rev 02 14.08.18 RESTORED 4
Oxytocin SHANGHAI SOHO-YIMING PHARMACEUTICALS CO., LTD. China R0-CEP 2011-003-Rev 01 27.03.17 RESTORED
Oxytocin SHANGHAI SOHO-YIMING PHARMACEUTICALS CO., LTD. China R1-CEP 2011-003-Rev 00 27.03.17 RESTORED
Paclitaxel Isolated from natural sources TAIHUA NATURAL PLANT PHARMACEUTICAL CO., LTD. China R0-CEP 2008-005-Rev 00 15.09.11 WITHDRAWN BY EDQM
Paracetamol Indukern Chemie AG Switzerland R0-CEP 2000-002-Rev 00 09.10.02 WITHDRAWN BY EDQM
Paracetamol Weistar Industry Limited China R0-CEP 2006-156-Rev 00 16.04.13 WITHDRAWN BY EDQM 2
Phenazone VANI PHARMA LABS LIMITED India R1-CEP 2001-042-Rev 01 26.02.10 WITHDRAWN BY EDQM
Phenoxymethylpenicillin potassium North China Pharmaceutical Co., Ltd. China R0-CEP 2006-019-Rev 00 04.11.13 WITHDRAWN BY EDQM 2
Pilocarpine hydrochloride Sourcetech Quimica Ltda Brazil R1-CEP 1997-034-Rev 03 11.03.13 RESTORED
Pilocarpine nitrate Sourcetech Quimica Ltda Brazil R1-CEP 2002-202-Rev 01 11.03.13 RESTORED
Pivampicillin Parabolic Drugs Ltd. India R0-CEP 2009-295-Rev 00 29.07.15 WITHDRAWN BY EDQM 2
Potassium clavulanate sterile Zhuhai United Laboratories Co., Ltd. China R0-CEP 2013-133-Rev 00 13.05.15 SUSPENDED 2
Povidone nominal K-value 30 BALAJI AMINES LIMITED India R0-CEP 2011-061-Rev 00 10.08.16 WITHDRAWN BY EDQM
Povidone, iodinated Hangzhou Sunflower Technology Dev Co., Ltd. China R0-CEP 2009-166-Rev 00 19.03.15 WITHDRAWN BY EDQM 2
Pravastatin sodium CONCORD BIOTECH LIMITED India R1-CEP 2010-018-Rev 01 31.10.17 RESTORED
Pravastatin sodium Zhejiang Hisun Pharmaceutical Co., Ltd. China R1-CEP 2002-009-Rev 01 28.10.16 SUSPENDED
Propyphenazone VANI PHARMA LABS LIMITED India R1-CEP 2001-041-Rev 01 26.02.10 WITHDRAWN BY EDQM
Protamine sulfate Biochem Corporation Japan R1-CEP 2000-162-Rev 00 05.07.13 WITHDRAWN BY EDQM 2
Pseudoephedrine hydrochloride Xinjiang Heshuo Ephedrine Product Co., Ltd China R0-CEP 2004-153-Rev 00 07.03.11 WITHDRAWN BY EDQM
Pseudoephedrine hydrochloride CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO., LTD. China R1-CEP 2002-217-Rev 03 24.08.17 RESTORED
Pyrazinamide Anuh Pharma Ltd India R1-CEP 2005-059-Rev 02 11.01.17 RESTORED
Pyrazinamide DIFC Co. Ltd. South Korea R1-CEP 2001-197-Rev 01 09.04.13 WITHDRAWN BY EDQM 3
Pyrazinamide Linaria Chemicals Ltd. Thailand R1-CEP 1998-070-Rev 02 21.01.13 WITHDRAWN BY EDQM 3
Quinine hydrochloride Aanjaneya Lifecare Ltd. India R0-CEP 2010-069-Rev 00 08.02.12 WITHDRAWN BY EDQM 2
Quinine hydrochloride Vital Laboratories Pvt. Ltd. India R0-CEP 2005-114-Rev 01 13.11.14 WITHDRAWN BY EDQM 3
Quinine sulfate Aanjaneya Lifecare Ltd. India R0-CEP 2009-387-Rev 00 08.02.12 WITHDRAWN BY EDQM 2
Quinine sulfate Vital Laboratories Pvt. Ltd. India R0-CEP 2005-117-Rev 01 13.11.14 WITHDRAWN BY EDQM 3
Ranitidine hydrochloride CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. China R1-CEP 2005-280-Rev 00 02.10.16 SUSPENDED 3
Reserpine Vital Laboratories Pvt. Ltd. India R0-CEP 2010-041-Rev 00 13.11.14 WITHDRAWN BY EDQM 3
Ribavirin ERREDUE S.P.A. Italy R0-CEP 2009-257-Rev 00 12.09.11 WITHDRAWN BY EDQM
Rifampicin Zhengzhou Minzhong Pharmaceutical Co. Ltd. China R0-CEP 2004-295-Rev 00 23.01.13 WITHDRAWN BY EDQM 3
Risperidone RPG Life Sciences Limited India R1-CEP 2004-135-Rev 01 04.07.13 RESTORED
Simvastatin JUBILANT GENERICS LIMITED India R1-CEP 2005-242-Rev 02 25.08.17 RESTORED
Simvastatin KREBS BIOCHEMICALS & INDUSTRIES LIMITED India R1-CEP 2004-051-Rev 03 25.08.17 RESTORED
Simvastatin Zhejiang Hisun Pharmaceutical Co., Ltd. China R1-CEP 2002-172-Rev 03 28.10.16 SUSPENDED
Simvastatin Zhejiang Jingxin Pharmaceutical Co., Ltd. China R1-CEP 2005-300-Rev 00 12.05.14 SUSPENDED
Simvastatin HENAN TOPFOND SCI-TECH CO., LTD. China R1-CEP 2006-232-Rev 02 03.05.18 RESTORED 4
Simvastatin Antioxidant Butylated Hydroxy Toluene 0.01% Artemis Biotech India R1-CEP 2003-257-Rev 04 27.04.18 RESTORED 4
Simvastatin Antioxidant butylhydroxyanisole HENAN TOPFOND SCI-TECH CO., LTD. China R1-CEP 2011-323-Rev 00 03.05.18 RESTORED 4
Simvastatin BHT Topfond Pharm Co., Ltd. China R0-CEP 2011-323-Rev 02 28.04.15 SUSPENDED 1
Simvastatin Butylated Hydroxy Anisole 50 - 150 ppm Artemis Biotech India R1-CEP 2006-091-Rev 01 27.04.18 RESTORED 4
Simvastatin Butylated hydroxy anisole 0.18-0.22% Artemis Biotech India R1-CEP 2007-155-Rev 02 27.04.18 RESTORED 4
Simvastatin With butylated hydroxyanisole Zhejiang Hisun Pharmaceutical Co., Ltd. China R1-CEP 2008-149-Rev 01 28.10.16 SUSPENDED
Simvastatin with 0.2% butylated hydroxy anisole Krebs Biochemicals & Industries Ltd. India R0-CEP 2007-210-Rev 01 17.11.15 RESTORED
Simvastatin with 0.2% butylated hydroxy anisole KREBS BIOCHEMICALS & INDUSTRIES LIMITED India R1-CEP 2007-210-Rev 01 25.08.17 RESTORED
Sodium alendronate trihydrate Shijiazhuang Pharmaceutical Group, Huasheng Pharma Co., Ltd. China R1-CEP 2006-189-Rev 00 07.08.15 WITHDRAWN BY EDQM 3
Sulfadiazine Northeast General Pharmaceutical Factory China R1-CEP 1996-109-Rev 03 28.08.08 WITHDRAWN BY EDQM
Sulfamethoxazole Indosol Drugs Limited India R1-CEP 1998-049-Rev 00 26.05.08 WITHDRAWN BY EDQM
Sulpiride Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. China R1-CEP 2005-077-Rev 01 20.07.15 SUSPENDED 1
Tamoxifen citrate Arevipharma GmbH Germany R1-CEP 2005-197-Rev 01 14.10.15 SUSPENDED 1
Telmisartan Watson Pharma Private Ltd. India R0-CEP 2010-261-Rev 00 13.12.13 WITHDRAWN BY EDQM 2
Theobromine CSPC Innovation Pharmaceutical Co., Ltd. China R0-CEP 2010-168-Rev 00 16.04.12 WITHDRAWN BY EDQM 2
Theophylline Bakul Aromatics and Chemicals Ltd India R1-CEP 1998-094-Rev 01 09.01.14 WITHDRAWN BY EDQM 3
Theophylline CSPC Innovation Pharmaceutical Co., Ltd. China R0-CEP 2006-087-Rev 01 16.04.12 WITHDRAWN BY EDQM 2
Theophylline KW Pfannenschmidt GmbH Germany R0-CEP 1998-018-Rev 01 02.08.04 WITHDRAWN BY EDQM
Theophylline-ethylenediamine anhydrous CSPC Innovation Pharmaceutical Co., Ltd. China R0-CEP 2007-345-Rev 01 16.04.12 WITHDRAWN BY EDQM 2
Thiopental Sodium And Sodium Carbonate Sterile Chemische Fabrik Berg GmbH Germany R1-CEP 2007-181-Rev 00 26.11.15 RESTORED 2
Tiamulin hydrogen fumarate for veterinary use ERREDUE S.P.A. Italy R0-CEP 2007-008-Rev 01 12.09.11 WITHDRAWN BY EDQM
Ticlopidine hydrochloride RPG Life Sciences Limited India R1-CEP 2003-066-Rev 00 04.07.13 RESTORED
Ticlopidine hydrochloride S.I.M.S. S.R.L. Italy R1-CEP 2002-106-Rev 01 09.02.15 RESTORED
Tolbutamide Albert David Ltd India R1-CEP 2000-021-Rev 01 18.02.11 WITHDRAWN BY EDQM
Tolbutamide Kothari Phytochemicals International India R0-CEP 2003-006-Rev 00 03.06.09 WITHDRAWN BY EDQM
Triflusal Estechpharma Co., Ltd. South Korea R1-CEP 2004-195-Rev 01 11.04.13 WITHDRAWN BY EDQM 2
Trimetazidine dihydrochloride Nivedita Chemicals Pvt. Ltd. India R0-CEP 2007-245-Rev 02 22.07.13 RESTORED
Trimetazidine dihydrochloride Sharon Bio-Medicine Ltd India R0-CEP 2010-075-Rev 02 27.06.14 RESTORED
Trimethoprim Punjab Chemicals and Crop Protection Ltd. India R1-CEP 1999-037-Rev 02 16.10.15 RESTORED
Troxerutin Ergypharm France R0-CEP 2006-153-Rev 01 20.12.11 SUSPENDED 4
Valsartan ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. China R0-CEP 2013-159-Rev 01 17.01.18 SUSPENDED 3
Valsartan ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. China R1-CEP 2010-072-Rev 00 09.06.16 SUSPENDED 3
Valsartan Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2013-095-Rev 00 28.10.16 SUSPENDED
Valsartan ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. China R0-CEP 2014-162-Rev 00 03.11.16 SUSPENDED 3
Valsartan Process III HETERO LABS LIMITED India R0-CEP 2016-069-Rev 01 04.05.18 SUSPENDED 3
Vancomycin hydrochloride CONCORD BIOTECH LIMITED India R1-CEP 2010-120-Rev 00 31.10.17 RESTORED
Venlafaxine hydrochloride Amoli Organics Priv Ltd. India R0-CEP 2008-092-Rev 01 13.05.14 RESTORED
Vinorelbine tartrate Zhejiang Hisun Pharmaceutical Co., Ltd. China R1-CEP 2005-146-Rev 01 28.10.16 SUSPENDED
Zidovudine MATRIX LABORATORIES (XIAMEN) LTD. China R0-CEP 2003-276-Rev 01 04.01.10 WITHDRAWN BY EDQM
Zidovudine ST PHARM CO., LTD. South Korea R1-CEP 1998-117-Rev 03 11.04.13 WITHDRAWN BY EDQM
Zopiclone Calyx Chemicals & Pharmaceuticals Ltd. India R1-CEP 2001-203-Rev 01 01.03.12 RESTORED

Reason for action

  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)
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