A maioria dos medicamentos na Europa contém ingredientes farmacêuticos ativos (APIs), que são descritos nas monografias específicas API da Farmacopeia Europeia. A qualidade API dessas aplicações de produtos farmacêuticos pode ser verificada com a ajuda de um "Certificado de Conformidade da Monografia da Farmacopéia Européia" (CEP) da Direcção Europeia da Qualidade dos Medicamentos e Cuidados de Saúde (EDQM).
A EDQM realiza inspeções baseadas em risco de locais de fabricação, a fim de comprovar a conformidade GMP do dossiê aprovado com a fabricação de API no local. Como resultado, o CEP pode ser suspenso ou mesmo retirado devido a diferentes razões. A seguinte lista de resultados de inspeção atual é baseada em dados da EDQM. Não assumimos nenhuma responsabilidade ou garantia pela exatidão ou integridade dos dados fornecidos.
Um certificado válido do CEP não exime os fabricantes de medicamentos de sua obrigação de monitorar seus fornecedores de API de maneira profissional e rigorosa, seja POR eles mesmos ou por meio de terceiros. A Diapharm pode fazer isso por você. Contate-Nos!
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| 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 | South Korea | R1-CEP 2001-160-Rev 02 | 11.04.13 | WITHDRAWN |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 | South Korea | R1-CEP 2004-006-Rev 00 | 11.04.13 | WITHDRAWN |
| Acetylsalicylic acid | Chimprod SA | Romania | R1-CEP 1994-014-Rev 02 | 20.12.11 | WITHDRAWN |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 S.A. | Colombia | R0-CEP 2006-195-Rev 00 | 20.04.12 | WITHDRAWN |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7017/7018, granular powder 7028, PR powder 7029 | Alta Laboratories Ltd | India | R1-CEP 2000-013-Rev 01 | 25.05.09 | WITHDRAWN |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 | China | R0-CEP 2004-189-Rev 02 | 04.10.10 | WITHDRAWN |
| Ambroxol hydrochloride | KORES (INDIA) LIMITED | India | R0-CEP 2013-115-Rev 01 | 18.12.18 | WITHDRAWN |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 |