Panorama actual de los CEP suspendidos, retirados y restaurados

La mayoría de los medicamentos en Europa contienen ingredientes farmacéuticos activos (API), que se describen en las monografías específicas de API de la Farmacopea Europea. La calidad API de dichas aplicaciones de productos farmacéuticos se puede comprobar con la ayuda de un "Certificado de idoneidad para las monografías de la Farmacopea Europea" (CEP) de la Dirección Europea de Calidad del Medicamento y la Asistencia Sanitaria (EDQM).

La EDQM lleva a cabo inspecciones basadas en el riesgo de sitios de fabricación con el fin de probar el cumplimiento GMP y la conformidad del dossier aprobado con la fabricación de API en el sitio. Como resultado, el CEP puede ser suspendido e incluso retirado debido a diferentes motivos. La siguiente lista de resultados de inspección actuales se basa en datos de la EDQM. No asumimos ninguna responsabilidad o garantía por la exactitud o integridad de los datos proporcionados.

Un certificado de CEP válido no exime a los fabricantes de medicamentos de su obligación de monitorear a sus proveedores de API de manera profesional y rigurosa, ya sea ellos mismos o a través de un tercero. Diapharm puede hacer eso por ustedes. ¡Contáctenos!

Eimear Schulte
Associate Director

Judith Gorschlüter
Consultant

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Certificados CEP: Resultados actuales de inspección por API

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[x] Acamprosate calcium, Estechpharma Co., Ltd. [x] Acarbose, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Aceclofenac, Estechpharma Co., Ltd. [x] Acetylsalicylic acid, Chimprod SA [x] Acetylsalicylic acid, Industria Quimica Andina & Cia. S.A. [x] Acetylsalicylic acid Crystals 7010/7011, fines 7012, granules 7017/7018, granular powder 7028, PR powder 7029, Alta Laboratories Ltd [x] Adenosine, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Albendazole, UNIMARK REMEDIES LIMITED [x] Allopurinol, Shanghai OSD Co., Ltd. [x] Ambroxol hydrochloride, KORES (INDIA) LIMITED [x] Ambroxol hydrochloride, OLON S.P.A. IT [x] Amlodipine besilate, Smruthi Organics Ltd. [x] Amlodipine besilate , Oman Chemicals And Pharmaceuticals L.L.C. [x] Amoxicillin sodium Sterile, ZHUHAI UNITED LABORATORIES CO, LTD. [x] Amoxicillin sodium sterile, Zhuhai United Laboratories Co., Ltd. [x] Amoxicillin trihydrate, Parabolic Drugs Ltd. [x] Amoxicillin trihydrate , Oman Chemicals And Pharmaceuticals L.L.C. [x] Amoxicillin trihydrate Powder, compacted and micronised powder, KDL Biotech Limited [x] Ampicillin trihydrate, Parabolic Drugs Ltd. [x] Ampicillin trihydrate , Oman Chemicals And Pharmaceuticals L.L.C. [x] Ampicillin, anhydrous, Parabolic Drugs Ltd. [x] Articaine hydrochloride, S.I.M.S. S.R.L. [x] Ascorbic acid, BASF SE [x] Ascorbic acid, HEBEI WELCOME PHARMACEUTICAL CO. [x] Atorvastatin calcium trihydrate, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Atropine sulfate, RESONANCE LABORATORIES PVT. LTD. [x] Azathioprine, RPG Life Sciences Limited [x] Bacampicillin hydrochloride, Parabolic Drugs Ltd. [x] Benzylpenicillin, procaine, North China Pharmaceutical Group Semisyntech Co., Ltd. [x] Benzylpenicillin, procaine, North China Pharmaceutical Group Semisyntech Co., Ltd. [x] Bicalutamide, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Bleomycin Sulfate Alternative process, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Bupivacaine hydrochloride, S.I.M.S. S.R.L. [x] Buprenorphine, Rusan Pharma Ltd. [x] Buprenorphine hydrochloride, Rusan Pharma Ltd. [x] Caffeine, CSPC Innovation Pharmaceutical Co., Ltd. [x] Caffeine, Tianjin Zhongan Pharmaceutical Co., Ltd. [x] Calcium dobesilate monohydrate, Bajaj Healthcare Limited [x] Calcium glucoheptonate, Global Calcium Private Limited [x] Calcium gluconate, Global Calcium Private Limited [x] Calcium gluconate for injection, Global Calcium Private Limited [x] Capecitabine, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Carbamazepine, Amoli Organics Priv Ltd. [x] Carbamazepine, Bajaj Healthcare Limited [x] Carbidopa, Smruthi Organics Ltd. [x] Cefaclor, Surya Pharmaceuticals Ltd. [x] Cefalexin monohydrate, Surya Pharmaceuticals Ltd. [x] Cefixime, Surya Pharmaceuticals Ltd. [x] Cefixime , Dhanuka Laboratories Ltd. [x] Ceftazidime pentahydrate with sodium carbonate for injection, ANTIBIOTICOS DO BRASIL LTDA. [x] Ceftriaxone sodium sterile, Kukje Pharmaceutical Ind. Co., Ltd. [x] Cefuroxime axetil, Surya Pharmaceuticals Ltd. [x] Cefuroxime axetil , Dhanuka Laboratories Ltd. [x] Cefuroxime sodium Sterile, Kukje Pharmaceutical Ind. Co., Ltd. [x] Celecoxib, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Chlorhexidine digluconate sodium, Bajaj Healthcare Limited [x] Chlorobutanol hemihydrate, Polydrug Laboratories Pvt., Ltd. [x] Chlorpropamide, Albert David Ltd [x] Cholesterol, Millipore [x] Ciclosporin, CONCORD BIOTECH LIMITED [x] Ciclosporin, Taishan City Chemical Pharm. Co., Ltd. [x] Cilastatin sodium sterile, Zhuhai United Laboratories Co., Ltd. [x] Cilastatin sodium, sterile, ZHUHAI UNITED LABORATORIES CO, LTD. [x] Cimetidine, Wuxi Kaili Pharmaceutical Co., Ltd. [x] Cinnarizine, Fleming Laboratories Ltd. [x] Ciprofloxacin hydrochloride, Smruthi Organics Ltd. [x] Cladribine, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Clindamycin hydrochloride, Suzhou No.4 Pharmaceutical Factory [x] Clindamycin phosphate, Suzhou No.4 Pharmaceutical Factory [x] Cloxacillin sodium, KDL Biotech Limited [x] Cloxacillin sodium, Parabolic Drugs Ltd. [x] Colchicine, Sanmar Speciality Chemicals Limited [x] Colchicine, Vital Laboratories Pvt. Ltd. [x] Colistin sulfate, Zhejiang Apeloa Kangyu Bio-Pharm Co., Ltd. [x] Cyclophosphamide, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Cytarabine, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Daunorubicin Hydrochloride, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Diclofenac Sodium, Henan Dongtai Pharm Co., Ltd. [x] Diclofenac sodium, Ningbo Smart Pharmaceutical Co., Ltd. [x] Dicloxacillin sodium, Parabolic Drugs Ltd. [x] Digoxin, Vital Laboratories Pvt. Ltd. [x] Diosmin, Chengdu Okay Pharmaceutical Co., Ltd. [x] Diosmin, Elder Pharmaceuticals Ltd. [x] Diosmin, Hunan Yuantong Pharm Co., Ltd. [x] Diosmin, Shaanxi Huifeng Phramaceutical Ltd. [x] Diprophylline, CSPC Innovation Pharmaceutical Co., Ltd. [x] Dipyridamole, S.I.M.S. S.R.L. [x] Docetaxel trihydrate, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Doxazosin mesilate, Porton Pharmaceutical Ltd. [x] Doxorubicin Hydrochloride, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Doxorubicin Hydrochloride Fermentation process, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Doxycycline hyclate, KUNSHAN CHEMICAL AND PHARMACEUTICAL FACTORY [x] Doxycycline hyclate, Shanghai International Pharmaceutical Co., Ltd. [x] Doxycycline monohydrate, KUNSHAN CHEMICAL AND PHARMACEUTICAL FACTORY [x] Doxycycline monohydrate, Shanghai International Pharmaceutical Co., Ltd. [x] Enalapril maleate, GULF OIL Corporation Limited [x] Enoxaparin sodium, Dongying Tiandong Pharmaceutical Co., Ltd. [x] Ephedrine hydrochloride, Xinjiang Heshuo Ephedrine Product Co., Ltd [x] Epirubicin hydrochloride, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Erythromycin, Anuh Pharma Ltd [x] Erythromycin, Mehta API Pvt. Ltd [x] Erythromycin ethylsuccinate, AbbVie Inc. US 60064 North Chicago [x] Erythromycin ethylsuccinate, Anuh Pharma Ltd [x] Erythromycin stearate, AbbVie Inc. US 60064 North Chicago [x] Ethinylestradiol, Jenapharm GmbH & Co KG [x] Fentanyl, Rusan Pharma Ltd. [x] Fenticonazole nitrate, Optimus Drugs Private Ltd. [x] Ferrous fumarate, Polydrug Laboratories Pvt., Ltd. [x] Flucloxacillin sodium, Parabolic Drugs Ltd. [x] Flucloxacillin sodium , Oman Chemicals And Pharmaceuticals L.L.C. [x] Flucloxacillin sodium Process II, Parabolic Drugs Ltd. [x] Fluconazole, Polydrug Laboratories Pvt., Ltd. [x] Fludarabine phosphate, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Flunarizine dihydrochloride, Fleming Laboratories Ltd. [x] Fluorouracil, Nantong Haiers Pharm Co., Ltd. [x] Fluvastatin sodium, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Folic Acid, Hebei Jiheng (Group) Pharmaceutical Co., Ltd. [x] Folic acid hydrate, HEBEI JIHENG (GROUP) PHARMACEUTICAL CO., LTD. [x] Gemcitabine hydrochloride, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Glimepiride, KORES (INDIA) LIMITED [x] Glimepiride, Oman Chemicals And Pharmaceuticals L.L.C. [x] Glucose, CSPC SHENGXUE GLUCOSE CO., LTD. [x] Granisetron hydrochloride, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Haloperidol, RPG Life Sciences Limited [x] Imipenem monohydrate, Zhuhai United Laboratories Co., Ltd. [x] Imipenem monohydrate Sterile, ZHUHAI UNITED LABORATORIES CO, LTD. [x] Indometacin, Macleods Phramaceuticals Ltd. [x] Irbesartan, ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. [x] Irbesartan , AUROBINDO PHARMA LIMITED [x] Isoniazid, Calyx Chemicals & Pharmaceuticals Ltd. [x] Isosorbide mononitrate, diluted, J P Laboratories Priv. Ltd. [x] Isosorbide mononitrate, diluted 70% and 80%, Calao SRL [x] Ivermectin, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Ketoprofen, Oman Chemicals And Pharmaceuticals L.L.C. [x] Ketoprofen, S.I.M.S. S.R.L. [x] Lactobionic acid, Global Calcium Private Limited [x] Lactulose, liquid, Milei GmbH [x] Lansoprazole, ENAL DRUGS PRIVATE LIMITED [x] Leflunomide, Formosa Laboratories Inc. [x] Letrozole, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Levonorgestrel, Jenapharm GmbH & Co KG [x] Lidocaine, S.I.M.S. S.R.L. [x] Lidocaine hydrochloride, S.I.M.S. S.R.L. [x] Lincomycin hydrochloride, NANYANG PUKANG PHARMACEUTICAL CO., LTD. [x] Lindane, Kanoria Chemicals & Industries Limited [x] Loperamide hydrochloride, Fleming Laboratories Ltd. [x] Losartan Potassium Form I, HETERO LABS LIMITED [x] Losartan Potassium Process II, ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. [x] Losartan potassium, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Lovastatin, CONCORD BIOTECH LIMITED [x] Lovastatin, KREBS BIOCHEMICALS & INDUSTRIES LIMITED [x] Lovastatin, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Magnesium citrate, anhydrous, Global Calcium Private Limited [x] Magnesium lactate dihydrate, Global Calcium Private Limited [x] Mefenamic acid, Ningbo Smart Pharmaceutical Co., Ltd. [x] Mepivacaine hydrochloride, S.I.M.S. S.R.L. [x] Meropenem trihydrate, UNIMARK REMEDIES LIMITED [x] Metamizole sodium monohydrate, VANI PHARMA LABS LIMITED [x] Metformin hydrochloride, Smruthi Organics Ltd. [x] Methotrexate, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Metoprolol succinate, Arevipharma GmbH [x] Metoprolol succinate, Polydrug Laboratories Pvt., Ltd. [x] Metoprolol tartrate, Polydrug Laboratories Pvt., Ltd. [x] Metoprolol tartrate, S.I.M.S. S.R.L. [x] Metronidazole, HUBEI HONGYUAN PHARMACEUTICAL TECHNOLOGY CO., LTD. [x] Metronidazole, Tianjin Zhongan Pharmaceutical Co., Ltd. [x] Mitomycin Alternative process, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Mupirocin, CONCORD BIOTECH LIMITED [x] Mupirocin calcium , CONCORD BIOTECH LIMITED [x] Mycophenolate mofetil, CONCORD BIOTECH LIMITED [x] Naltrexone hydrochloride, Rusan Pharma Ltd. [x] Netilmicin sulfate, Zhejiang Zhenyuan Pharmaceutical Co., Ltd. [x] Nifuroxazide, Suzhou No.5 Pharmaceutical Factory Co., Ltd. [x] Nitrofurantoin, Jinan Jinda Pharmaceutical Chemistry Co., Ltd. [x] Norfloxacin, Smruthi Organics Ltd. [x] Oxaliplatin, Desynth SA AR [x] Oxaliplatin, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Oxybutynin hydrochloride, RESONANCE LABORATORIES PVT. LTD. [x] Oxytetracycline dihydrate, Huashu Pharmaceutical Corporation [x] Oxytetracycline hydrochloride, Dafeng - Huashu Pharmaceutical Company Limited [x] Oxytetracycline hydrochloride , Dafeng - Huashu Pharmaceutical Company Limited [x] Oxytetracycline hydrochloride , JIANGXI GUOYAO PHARMACEUTICAL LIMITED LIABILITY COMPANY [x] Oxytocin, SHANGHAI SOHO-YIMING PHARMACEUTICALS CO., LTD. [x] Oxytocin, SHANGHAI SOHO-YIMING PHARMACEUTICALS CO., LTD. [x] Paclitaxel Isolated from natural sources, TAIHUA NATURAL PLANT PHARMACEUTICAL CO., LTD. [x] Paracetamol, Indukern Chemie AG [x] Paracetamol, Weistar Industry Limited [x] Phenazone, VANI PHARMA LABS LIMITED [x] Phenoxymethylpenicillin potassium, North China Pharmaceutical Co., Ltd. [x] Pilocarpine hydrochloride, Sourcetech Quimica Ltda [x] Pilocarpine nitrate, Sourcetech Quimica Ltda [x] Pivampicillin, Parabolic Drugs Ltd. [x] Potassium clavulanate sterile, Zhuhai United Laboratories Co., Ltd. [x] Povidone nominal K-value 30, BALAJI AMINES LIMITED [x] Povidone, iodinated, Hangzhou Sunflower Technology Dev Co., Ltd. [x] Pravastatin sodium, CONCORD BIOTECH LIMITED [x] Pravastatin sodium, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Propyphenazone, VANI PHARMA LABS LIMITED [x] Protamine sulfate, Biochem Corporation [x] Pseudoephedrine hydrochloride, Xinjiang Heshuo Ephedrine Product Co., Ltd [x] Pseudoephedrine hydrochloride , CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO., LTD. [x] Pyrazinamide, Anuh Pharma Ltd [x] Pyrazinamide, DIFC Co. Ltd. [x] Pyrazinamide, Linaria Chemicals Ltd. [x] Quinine hydrochloride, Aanjaneya Lifecare Ltd. [x] Quinine hydrochloride, Vital Laboratories Pvt. Ltd. [x] Quinine sulfate, Aanjaneya Lifecare Ltd. [x] Quinine sulfate, Vital Laboratories Pvt. Ltd. [x] Ranitidine hydrochloride, CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. [x] Reserpine, Vital Laboratories Pvt. Ltd. [x] Ribavirin, ERREDUE S.P.A. [x] Rifampicin, Zhengzhou Minzhong Pharmaceutical Co. Ltd. [x] Risperidone, RPG Life Sciences Limited [x] Simvastatin, JUBILANT GENERICS LIMITED [x] Simvastatin, KREBS BIOCHEMICALS & INDUSTRIES LIMITED [x] Simvastatin, SOUTHWEST SYNTHETIC PHARMACEUTICAL CORPORATION [x] Simvastatin, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Simvastatin, Zhejiang Jingxin Pharmaceutical Co., Ltd. [x] Simvastatin , HENAN TOPFOND SCI-TECH CO., LTD. [x] Simvastatin Antioxidant Butylated Hydroxy Toluene 0.01% , Artemis Biotech [x] Simvastatin Antioxidant butylhydroxyanisole, HENAN TOPFOND SCI-TECH CO., LTD. [x] Simvastatin BHT, Topfond Pharm Co., Ltd. [x] Simvastatin Butylated Hydroxy Anisole 50 - 150 ppm , Artemis Biotech [x] Simvastatin Butylated hydroxy anisole 0.18-0.22% , Artemis Biotech [x] Simvastatin With butylated hydroxyanisole, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Simvastatin with 0.2% butylated hydroxy anisole, Krebs Biochemicals & Industries Ltd. [x] Simvastatin with 0.2% butylated hydroxy anisole , KREBS BIOCHEMICALS & INDUSTRIES LIMITED [x] Sodium alendronate trihydrate, Shijiazhuang Pharmaceutical Group, Huasheng Pharma Co., Ltd. [x] Sulfadiazine, Northeast General Pharmaceutical Factory [x] Sulfamethoxazole, Indosol Drugs Limited [x] Sulpiride, Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. [x] Tamoxifen citrate, Arevipharma GmbH [x] Telmisartan, Watson Pharma Private Ltd. [x] Theobromine, CSPC Innovation Pharmaceutical Co., Ltd. [x] Theophylline, Bakul Aromatics and Chemicals Ltd [x] Theophylline, CSPC Innovation Pharmaceutical Co., Ltd. [x] Theophylline, KW Pfannenschmidt GmbH [x] Theophylline-ethylenediamine anhydrous, CSPC Innovation Pharmaceutical Co., Ltd. [x] Thiopental Sodium And Sodium Carbonate Sterile , Chemische Fabrik Berg GmbH [x] Tiamulin hydrogen fumarate for veterinary use, ERREDUE S.P.A. [x] Ticlopidine hydrochloride, RPG Life Sciences Limited [x] Ticlopidine hydrochloride, S.I.M.S. S.R.L. [x] Tolbutamide, Albert David Ltd [x] Tolbutamide, Kothari Phytochemicals International [x] Triflusal, Estechpharma Co., Ltd. [x] Trimetazidine dihydrochloride, Nivedita Chemicals Pvt. Ltd. [x] Trimetazidine dihydrochloride, Sharon Bio-Medicine Ltd [x] Trimethoprim, Punjab Chemicals and Crop Protection Ltd. [x] Troxerutin, Ergypharm [x] Valsartan, MYLAN LABORATORIES LIMITED [x] Valsartan, SIGNA S.A. DE C.V. MX [x] Valsartan, ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. [x] Valsartan, ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. [x] Valsartan, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Valsartan , ZHEJIANG CHANGMING PHARMACEUTICAL CO., LTD. [x] Valsartan Process II, AUROBINDO PHARMA LIMITED [x] Valsartan Process III, HETERO LABS LIMITED [x] Vancomycin hydrochloride, CONCORD BIOTECH LIMITED [x] Venlafaxine hydrochloride, Amoli Organics Priv Ltd. [x] Vinorelbine tartrate, Zhejiang Hisun Pharmaceutical Co., Ltd. [x] Zidovudine, MATRIX LABORATORIES (XIAMEN) LTD. [x] Zidovudine, ST PHARM CO., LTD. [x] Zopiclone, Calyx Chemicals & Pharmaceuticals Ltd.

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INGREDIENT	MANUFACTURER	COUNTRY	CEP NO.	DATE	ACTION
Zidovudine	MATRIX LABORATORIES (XIAMEN) LTD.	China	R0-CEP 2003-276-Rev 01	04.01.10	WITHDRAWN
Zopiclone	Calyx Chemicals & Pharmaceuticals Ltd.	India	R1-CEP 2001-203-Rev 01	01.03.12	RESTORED
Zidovudine	ST PHARM CO., LTD.	South Korea	R1-CEP 1998-117-Rev 03	11.04.13	WITHDRAWN

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Panorama actual de los CEP suspendidos, retirados y restaurados

Descarga de archivos

Certificados CEP: Resultados actuales de inspección por API

¡Contáctenos!

Teléfono: +49 (0)251 609350

E-mail: audits@diapharm.com