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
Associate Director Global Audit Solutions
Photo:  Judith Gorschlüter
Judith Gorschlüter
Consultant

Dateien zum Download


CEP-Zertifikate: Aktuelle Inspektionsergebnisse nach Wirkstoff








Ausgewählte Einträge:

INGREDIENT MANUFACTURER COUNTRY CEP NO. DATE ACTION
Acamprosate calcium Estechpharma Co., Ltd. South Korea R1-CEP 2001-160-Rev 02 11.04.13 WITHDRAWN
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 South Korea R1-CEP 2004-006-Rev 00 11.04.13 WITHDRAWN
Acetylsalicylic acid Chimprod SA Romania R1-CEP 1994-014-Rev 02 20.12.11 WITHDRAWN
Acetylsalicylic acid Industria Quimica Andina & Cia. S.A. Colombia R0-CEP 2006-195-Rev 00 20.04.12 WITHDRAWN
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granules 7017/7018, granular powder 7028, PR powder 7029 Alta Laboratories Ltd India R1-CEP 2000-013-Rev 01 25.05.09 WITHDRAWN
Adenosine Zhejiang Hisun Pharmaceutical Co., Ltd. China R0-CEP 2013-044-Rev 00 28.10.16 SUSPENDED
Albendazole UNIMARK REMEDIES LIMITED India R1-CEP 2001-448-Rev 04 28.11.18 SUSPENDED
Allopurinol Shanghai OSD Co., Ltd. China R0-CEP 2004-189-Rev 02 04.10.10 WITHDRAWN
Ambroxol hydrochloride KORES (INDIA) LIMITED India R0-CEP 2013-115-Rev 01 18.12.18 WITHDRAWN
Ambroxol hydrochloride OLON S.P.A. IT Italy R0-CEP 2015-012-Rev 00 10.04.17 SUSPENDED
Amlodipine besilate Smruthi Organics Ltd. India R0-CEP 2007-285-Rev 01 13.12.13 WITHDRAWN
Amlodipine besilate Oman Chemicals And Pharmaceuticals L.L.C. Oman R0-CEP 2010-089-Rev 00 14.12.18 SUSPENDED
Amoxicillin sodium Sterile ZHUHAI UNITED LABORATORIES CO, LTD. China R1-CEP 2013-125-Rev 00 12.10.18 RESTORED
Amoxicillin sodium sterile Zhuhai United Laboratories Co., Ltd. China R0-CEP 2013-125-Rev 01 13.05.15 SUSPENDED
Amoxicillin trihydrate Parabolic Drugs Ltd. India R1-CEP 2004-266-Rev 01 29.07.15 WITHDRAWN
Amoxicillin trihydrate Oman Chemicals And Pharmaceuticals L.L.C. Oman R1-CEP 1996-060-Rev 03 14.12.18 SUSPENDED
Amoxicillin trihydrate Powder, compacted and micronised powder KDL Biotech Limited India R0-CEP 1997-129-Rev 00 11.03.11 WITHDRAWN
Ampicillin trihydrate Parabolic Drugs Ltd. India R0-CEP 2011-083-Rev 00 29.07.15 WITHDRAWN
Ampicillin trihydrate Oman Chemicals And Pharmaceuticals L.L.C. Oman R1-CEP 1996-059-Rev 04 14.12.18 SUSPENDED
Ampicillin, anhydrous Parabolic Drugs Ltd. India R0-CEP 2011-090-Rev 00 29.07.15 WITHDRAWN
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
Ascorbic acid HEBEI WELCOME PHARMACEUTICAL CO. China R1-CEP 2008-185-Rev 00 26.08.14 SUSPENDED
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
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
Benzylpenicillin, procaine North China Pharmaceutical Group Semisyntech Co., Ltd. China R1-CEP 2004-001-Rev 01 03.03.15 WITHDRAWN
Benzylpenicillin, procaine North China Pharmaceutical Group Semisyntech Co., Ltd. China R1-CEP 2004-017-Rev 01 03.03.15 WITHDRAWN
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
Buprenorphine hydrochloride Rusan Pharma Ltd. India R1-CEP 2001-278-Rev 02 13.11.12 WITHDRAWN
Caffeine CSPC Innovation Pharmaceutical Co., Ltd. China R1-CEP 2003-156-Rev 00 16.04.12 WITHDRAWN
Caffeine Tianjin Zhongan Pharmaceutical Co., Ltd. China R0-CEP 2005-116-Rev 01 14.01.13 WITHDRAWN
Calcium dobesilate monohydrate Bajaj Healthcare Limited India R0-CEP 2010-209-Rev 00 26.06.12 WITHDRAWN
Calcium glucoheptonate Global Calcium Private Limited India R0-CEP 2009-259-Rev 00 06.12.12 WITHDRAWN
Calcium gluconate Global Calcium Private Limited India R1-CEP 2002-128-Rev 00 06.12.12 WITHDRAWN
Calcium gluconate for injection Global Calcium Private Limited India R1-CEP 2005-298-Rev 00 06.12.12 WITHDRAWN
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
Carbamazepine Bajaj Healthcare Limited India R1-CEP 2002-141-Rev 00 01.07.13 WITHDRAWN
Carbidopa Smruthi Organics Ltd. India R0-CEP 2006-138-Rev 01 13.12.13 WITHDRAWN
Cefaclor Surya Pharmaceuticals Ltd. India R0-CEP 2009-136-Rev 00 10.01.14 WITHDRAWN
Cefalexin monohydrate Surya Pharmaceuticals Ltd. India R0-CEP 2010-140-Rev 00 10.01.14 WITHDRAWN
Cefixime Surya Pharmaceuticals Ltd. India R0-CEP 2007-314-Rev 00 10.01.14 WITHDRAWN
Cefixime Dhanuka Laboratories Ltd. India R1-CEP 2003-014-Rev 02 02.06.14 WITHDRAWN
Ceftazidime pentahydrate with sodium carbonate for injection ANTIBIOTICOS DO BRASIL LTDA. Brazil R0-CEP 2010-026-Rev 01 16.03.17 SUSPENDED
Ceftriaxone sodium sterile Kukje Pharmaceutical Ind. Co., Ltd. South Korea R1-CEP 2000-017-Rev 00 13.07.10 WITHDRAWN
Cefuroxime axetil Surya Pharmaceuticals Ltd. India R0-CEP 2010-251-Rev 00 10.01.14 WITHDRAWN
Cefuroxime axetil Dhanuka Laboratories Ltd. India R0-CEP 2011-173-Rev 00 18.03.13 WITHDRAWN
Cefuroxime sodium Sterile Kukje Pharmaceutical Ind. Co., Ltd. South Korea R0-CEP 2004-050-Rev 00 13.07.10 WITHDRAWN
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
Chlorobutanol hemihydrate Polydrug Laboratories Pvt., Ltd. India R0-CEP 2009-112-Rev 00 26.10.16 WITHDRAWN
Chlorpropamide Albert David Ltd India R1-CEP 2000-020-Rev 01 18.02.11 WITHDRAWN
Cholesterol Millipore USA R1-CEP 2003-043-Rev 00 18.12.14 WITHDRAWN
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
Cilastatin sodium sterile Zhuhai United Laboratories Co., Ltd. China R0-CEP 2010-184-Rev 01 13.05.15 SUSPENDED
Cilastatin sodium, sterile ZHUHAI UNITED LABORATORIES CO, LTD. China R1-CEP 2010-184-Rev 01 12.10.18 RESTORED
Cimetidine Wuxi Kaili Pharmaceutical Co., Ltd. China R1-CEP 2002-008-Rev 01 15.12.15 WITHDRAWN
Cinnarizine Fleming Laboratories Ltd. India R0-CEP 2007-257-Rev 00 06.12.13 WITHDRAWN
Ciprofloxacin hydrochloride Smruthi Organics Ltd. India R0-CEP 2011-051-Rev 00 13.12.13 WITHDRAWN
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
Clindamycin phosphate Suzhou No.4 Pharmaceutical Factory China R0-CEP 2007-250-Rev 01 20.12.13 WITHDRAWN
Cloxacillin sodium KDL Biotech Limited India R0-CEP 1997-131-Rev 01 14.03.11 WITHDRAWN
Cloxacillin sodium Parabolic Drugs Ltd. India R0-CEP 2010-350-Rev 00 29.07.15 WITHDRAWN
Colchicine Sanmar Speciality Chemicals Limited India R1-CEP 2002-062-Rev 01 18.11.09 SUSPENDED
Colchicine Vital Laboratories Pvt. Ltd. India R0-CEP 2011-016-Rev 00 13.11.14 WITHDRAWN
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
Diclofenac sodium Ningbo Smart Pharmaceutical Co., Ltd. China R1-CEP 1999-075-Rev 01 18.02.11 WITHDRAWN
Dicloxacillin sodium Parabolic Drugs Ltd. India R0-CEP 2011-052-Rev 00 29.07.15 WITHDRAWN
Digoxin Vital Laboratories Pvt. Ltd. India R0-CEP 2009-281-Rev 00 13.11.14 WITHDRAWN
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
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
Diprophylline CSPC Innovation Pharmaceutical Co., Ltd. China R0-CEP 2009-033-Rev 00 16.04.12 WITHDRAWN
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
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
Doxycycline hyclate Shanghai International Pharmaceutical Co., Ltd. China R2-CEP 1992-018-Rev 00 22.10.10 WITHDRAWN
Doxycycline monohydrate KUNSHAN CHEMICAL AND PHARMACEUTICAL FACTORY China R0-CEP 2003-226-Rev 00 02.07.08 WITHDRAWN
Doxycycline monohydrate Shanghai International Pharmaceutical Co., Ltd. China R1-CEP 1996-064-Rev 04 22.10.10 WITHDRAWN
Enalapril maleate GULF OIL Corporation Limited India R0-CEP 2005-206-Rev 00 13.10.10 WITHDRAWN
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
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
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
Ethinylestradiol Jenapharm GmbH & Co KG Germany R2-CEP 1996-014-Rev 01 11.04.08 WITHDRAWN
Fentanyl Rusan Pharma Ltd. India R0-CEP 2005-164-Rev 00 13.11.12 WITHDRAWN
Fenticonazole nitrate Optimus Drugs Private Ltd. India R0-CEP 2013-056-Rev 02 19.10.15 SUSPENDED
Ferrous fumarate Polydrug Laboratories Pvt., Ltd. India R0-CEP 2010-147-Rev 00 26.10.16 WITHDRAWN
Flucloxacillin sodium Parabolic Drugs Ltd. India R0-CEP 2005-064-Rev 00 29.07.15 WITHDRAWN
Flucloxacillin sodium Oman Chemicals And Pharmaceuticals L.L.C. Oman R1-CEP 2004-120-Rev 00 14.12.18 SUSPENDED
Flucloxacillin sodium Process II Parabolic Drugs Ltd. India R0-CEP 2010-311-Rev 00 29.07.15 WITHDRAWN
Fluconazole Polydrug Laboratories Pvt., Ltd. India R0-CEP 2010-247-Rev 00 26.10.16 WITHDRAWN
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
Fluorouracil Nantong Haiers Pharm Co., Ltd. China R1-CEP 2008-183-Rev 00 30.03.15 WITHDRAWN
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
Folic acid hydrate HEBEI JIHENG (GROUP) PHARMACEUTICAL CO., LTD. China R1-CEP 2005-031-Rev 00 28.09.18 RESTORED
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 18.12.18 WITHDRAWN
Glimepiride Oman Chemicals And Pharmaceuticals L.L.C. Oman R1-CEP 2009-299-Rev 00 14.12.18 SUSPENDED
Glucose CSPC SHENGXUE GLUCOSE CO., LTD. China R1-CEP 2004-274-Rev 03 09.08.16 WITHDRAWN
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
Imipenem monohydrate Sterile ZHUHAI UNITED LABORATORIES CO, LTD. China R1-CEP 2010-163-Rev 01 12.10.18 RESTORED
Indometacin Macleods Phramaceuticals Ltd. India R0-CEP 2009-314-Rev 00 25.08.15 SUSPENDED
Irbesartan ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. China R1-CEP 2010-033-Rev 01 14.01.19 SUSPENDED
Irbesartan AUROBINDO PHARMA LIMITED India R1-CEP 2009-283-Rev 04 02.04.19 RESTORED
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
Isosorbide mononitrate, diluted 70% and 80% Calao SRL Italy R0-CEP 2001-329-Rev 00 06.01.04 WITHDRAWN
Ivermectin Zhejiang Hisun Pharmaceutical Co., Ltd. China R1-CEP 1999-176-Rev 03 28.10.16 SUSPENDED
Ketoprofen Oman Chemicals And Pharmaceuticals L.L.C. Oman R1-CEP 2009-242-Rev 00 14.12.18 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
Lactulose, liquid Milei GmbH Germany R1-CEP 1998-021-Rev 01 20.08.13 WITHDRAWN
Lansoprazole ENAL DRUGS PRIVATE LIMITED India R1-CEP 2008-204-Rev 01 24.04.18 RESTORED
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
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
Loperamide hydrochloride Fleming Laboratories Ltd. India R0-CEP 2005-247-Rev 01 06.12.13 WITHDRAWN
Losartan Potassium Form I HETERO LABS LIMITED India R1-CEP 2009-247-Rev 02 29.01.19 SUSPENDED
Losartan Potassium Process II ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. China R1-CEP 2010-139-Rev 00 14.01.19 SUSPENDED
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
Magnesium lactate dihydrate Global Calcium Private Limited India R0-CEP 2008-257-Rev 00 06.12.12 WITHDRAWN
Mefenamic acid Ningbo Smart Pharmaceutical Co., Ltd. China R1-CEP 2000-043-Rev 01 18.02.11 WITHDRAWN
Mepivacaine hydrochloride S.I.M.S. S.R.L. Italy R0-CEP 2010-129-Rev 00 09.02.15 RESTORED
Meropenem trihydrate UNIMARK REMEDIES LIMITED India R0-CEP 2015-148-Rev 00 10.09.18 SUSPENDED
Metamizole sodium monohydrate VANI PHARMA LABS LIMITED India R1-CEP 2001-220-Rev 01 26.02.10 WITHDRAWN
Metformin hydrochloride Smruthi Organics Ltd. India R1-CEP 2005-232-Rev 00 13.12.13 WITHDRAWN
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
Metoprolol succinate Polydrug Laboratories Pvt., Ltd. India R0-CEP 2009-170-Rev 01 07.05.15 WITHDRAWN
Metoprolol tartrate Polydrug Laboratories Pvt., Ltd. India R0-CEP 2009-152-Rev 01 26.10.16 WITHDRAWN
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
Metronidazole Tianjin Zhongan Pharmaceutical Co., Ltd. China R1-CEP 2002-119-Rev 00 14.01.13 WITHDRAWN
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
Netilmicin sulfate Zhejiang Zhenyuan Pharmaceutical Co., Ltd. China R1-CEP 2006-036-Rev 00 29.09.17 WITHDRAWN
Nifuroxazide Suzhou No.5 Pharmaceutical Factory Co., Ltd. China R0-CEP 2006-074-Rev 00 20.03.14 WITHDRAWN
Nitrofurantoin Jinan Jinda Pharmaceutical Chemistry Co., Ltd. China R0-CEP 2011-240-Rev 01 21.07.16 WITHDRAWN
Norfloxacin Smruthi Organics Ltd. India R1-CEP 2001-409-Rev 02 13.12.13 WITHDRAWN
Oxaliplatin Desynth SA AR Argentinia R0-CEP 2005-158-Rev 00 20.04.12 WITHDRAWN
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
Oxytetracycline dihydrate Huashu Pharmaceutical Corporation China R1-CEP 2002-211-Rev 00 20.03.17 WITHDRAWN
Oxytetracycline hydrochloride Dafeng - Huashu Pharmaceutical Company Limited China R1-CEP 2002-070-Rev 00 23.05.17 SUSPENDED
Oxytetracycline hydrochloride Dafeng - Huashu Pharmaceutical Company Limited China R1-CEP 2002-070-Rev 00 23.05.17 SUSPENDED
Oxytetracycline hydrochloride JIANGXI GUOYAO PHARMACEUTICAL LIMITED LIABILITY COMPANY China R1-CEP 2001-125-Rev 02 14.08.18 RESTORED
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
Paracetamol Indukern Chemie AG Switzerland R0-CEP 2000-002-Rev 00 09.10.02 WITHDRAWN
Paracetamol Weistar Industry Limited China R0-CEP 2006-156-Rev 00 16.04.13 WITHDRAWN
Phenazone VANI PHARMA LABS LIMITED India R1-CEP 2001-042-Rev 01 26.02.10 WITHDRAWN
Phenoxymethylpenicillin potassium North China Pharmaceutical Co., Ltd. China R0-CEP 2006-019-Rev 00 04.11.13 WITHDRAWN
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
Potassium clavulanate sterile Zhuhai United Laboratories Co., Ltd. China R0-CEP 2013-133-Rev 02 12.10.18 RESTORED
Povidone nominal K-value 30 BALAJI AMINES LIMITED India R0-CEP 2011-061-Rev 00 10.08.16 WITHDRAWN
Povidone, iodinated Hangzhou Sunflower Technology Dev Co., Ltd. China R0-CEP 2009-166-Rev 00 19.03.15 WITHDRAWN
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
Protamine sulfate Biochem Corporation Japan R1-CEP 2000-162-Rev 00 05.07.13 WITHDRAWN
Pseudoephedrine hydrochloride Xinjiang Heshuo Ephedrine Product Co., Ltd China R0-CEP 2004-153-Rev 00 07.03.11 WITHDRAWN
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
Pyrazinamide Linaria Chemicals Ltd. Thailand R1-CEP 1998-070-Rev 02 21.01.13 WITHDRAWN
Quinine hydrochloride Aanjaneya Lifecare Ltd. India R0-CEP 2010-069-Rev 00 08.02.12 WITHDRAWN
Quinine hydrochloride Vital Laboratories Pvt. Ltd. India R0-CEP 2005-114-Rev 01 13.11.14 WITHDRAWN
Quinine sulfate Aanjaneya Lifecare Ltd. India R0-CEP 2009-387-Rev 00 08.02.12 WITHDRAWN
Quinine sulfate Vital Laboratories Pvt. Ltd. India R0-CEP 2005-117-Rev 01 13.11.14 WITHDRAWN
Ranitidine hydrochloride CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. China R1-CEP 2005-280-Rev 00 02.10.16 SUSPENDED
Reserpine Vital Laboratories Pvt. Ltd. India R0-CEP 2010-041-Rev 00 13.11.14 WITHDRAWN
Ribavirin ERREDUE S.P.A. Italy R0-CEP 2009-257-Rev 00 12.09.11 WITHDRAWN
Rifampicin Zhengzhou Minzhong Pharmaceutical Co. Ltd. China R0-CEP 2004-295-Rev 00 23.01.13 WITHDRAWN
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 SOUTHWEST SYNTHETIC PHARMACEUTICAL CORPORATION China R1-CEP 2010-116-Rev 00 29.01.19 SUSPENDED
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
Simvastatin Antioxidant Butylated Hydroxy Toluene 0.01% Artemis Biotech India R1-CEP 2003-257-Rev 04 27.04.18 RESTORED
Simvastatin Antioxidant butylhydroxyanisole HENAN TOPFOND SCI-TECH CO., LTD. China R1-CEP 2011-323-Rev 00 03.05.18 RESTORED
Simvastatin BHT Topfond Pharm Co., Ltd. China R0-CEP 2011-323-Rev 02 28.04.15 SUSPENDED
Simvastatin Butylated Hydroxy Anisole 50 - 150 ppm Artemis Biotech India R1-CEP 2006-091-Rev 01 27.04.18 RESTORED
Simvastatin Butylated hydroxy anisole 0.18-0.22% Artemis Biotech India R1-CEP 2007-155-Rev 02 27.04.18 RESTORED
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
Sulfadiazine Northeast General Pharmaceutical Factory China R1-CEP 1996-109-Rev 03 28.08.08 WITHDRAWN
Sulfamethoxazole Indosol Drugs Limited India R1-CEP 1998-049-Rev 00 26.05.08 WITHDRAWN
Sulpiride Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. China R1-CEP 2005-077-Rev 01 20.07.15 SUSPENDED
Tamoxifen citrate Arevipharma GmbH Germany R1-CEP 2005-197-Rev 01 14.10.15 SUSPENDED
Telmisartan Watson Pharma Private Ltd. India R0-CEP 2010-261-Rev 00 13.12.13 WITHDRAWN
Theobromine CSPC Innovation Pharmaceutical Co., Ltd. China R0-CEP 2010-168-Rev 00 16.04.12 WITHDRAWN
Theophylline Bakul Aromatics and Chemicals Ltd India R1-CEP 1998-094-Rev 01 09.01.14 WITHDRAWN
Theophylline CSPC Innovation Pharmaceutical Co., Ltd. China R0-CEP 2006-087-Rev 01 16.04.12 WITHDRAWN
Theophylline KW Pfannenschmidt GmbH Germany R0-CEP 1998-018-Rev 01 02.08.04 WITHDRAWN
Theophylline-ethylenediamine anhydrous CSPC Innovation Pharmaceutical Co., Ltd. China R0-CEP 2007-345-Rev 01 16.04.12 WITHDRAWN
Thiopental Sodium And Sodium Carbonate Sterile Chemische Fabrik Berg GmbH Germany R1-CEP 2007-181-Rev 02 01.03.19 RESTORED
Tiamulin hydrogen fumarate for veterinary use ERREDUE S.P.A. Italy R0-CEP 2007-008-Rev 01 12.09.11 WITHDRAWN
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
Tolbutamide Kothari Phytochemicals International India R0-CEP 2003-006-Rev 00 03.06.09 WITHDRAWN
Triflusal Estechpharma Co., Ltd. South Korea R1-CEP 2004-195-Rev 01 11.04.13 WITHDRAWN
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
Valsartan MYLAN LABORATORIES LIMITED India R1-CEP 2009-396-Rev 03 16.11.18 SUSPENDED
Valsartan SIGNA S.A. DE C.V. MX Mexico R0-CEP 2011-231-Rev 00 17.12.18 SUSPENDED
Valsartan ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. China R0-CEP 2013-159-Rev 01 17.01.18 SUSPENDED
Valsartan ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. China R1-CEP 2010-072-Rev 00 09.06.16 SUSPENDED
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
Valsartan Process II AUROBINDO PHARMA LIMITED India R1-CEP 2011-174-Rev 00 19.12.18 SUSPENDED
Valsartan Process III HETERO LABS LIMITED India R0-CEP 2016-069-Rev 01 04.05.18 SUSPENDED
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
Zidovudine ST PHARM CO., LTD. South Korea R1-CEP 1998-117-Rev 03 11.04.13 WITHDRAWN
Zopiclone Calyx Chemicals & Pharmaceuticals Ltd. India R1-CEP 2001-203-Rev 01 01.03.12 RESTORED
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