Informes de auditoría API disponibles

Diapharm coordina auditorías API de tercera parte en todo el mundo para evaluar la conformidad de los materias de partida, excipientes  y principios activos farmacéuticos (API) con Buenas Prácticas de Fabricación (GMP). Hemos excedido la marca de 500 informes de auditoría de APIs.

Las auditorías son realizadas por auditores de un órgano de inspección independiente y  acreditado ISO 17020 (tipo A). La acreditación asegura el más alto nivel de calidad, independencia y aceptación  de los informes de auditoría por parte de las autoridades.

Una lista de los actuales informes de auditoría se encuentra disponible aquí en el formato PDF.

Debido a razones de confidencialidad no todas las auditorías se encuentran listadas, por favor contáctenos si requiere otro informe de auditoría específico.

Nuestros servicios

  • Informes de auditoría API exhaustivos.
  • Tratamiento de las desviaciones (evaluación de las acciones correctivas y preventivas).
  • CV de los auditores.
  • Coordinación de los requisitos necesarios (aprobación del fabricante, acuerdo de confidencialidad, etc)

Contáctenos por más información sobre informes de auditoría auditsNOSPAM@diapharm.com!

Lista de Informes de Auditoría

API molecule Manufacturer Town Country Audit date
Cefaclor Monohydrate ACS Dobfar Vimercate Italy Oct 14
Cefadroxil Monohydrate ACS Dobfar Vimercate Italy Oct 14
Cefalexine Monohydrate ACS Dobfar Vimercate Italy Oct 14
Cefalotine Sodium ACS Dobfar Vimercate Italy Oct 14
Cefazidime Dichlorhydrate ACS Dobfar Vimercate Italy Oct 14
Cefotetan ACS Dobfar Vimercate Italy Oct 14
Cefprozil Monohydrate ACS Dobfar Vimercate Italy Oct 14
Cefradine Monohydrate ACS Dobfar Vimercate Italy Oct 14
Vinblastine Sulfate Ajinomoto Omnichem Wetteren / Louvian-La-Neuve Belgium Nov 14
Vincristine Sulfate Ajinomoto Omnichem Wetteren / Louvian-La-Neuve Belgium Nov 14
Vindesine Sulfate Ajinomoto Omnichem Wetteren / Louvian-La-Neuve Belgium Nov 14
Hyoscine Alchem Faridabad India Jan 15
Phenobarbital Alkaloida Tiszavasuari Hungary Jan 14
Scopolamine Butyl Bromide Alkaloids Andrah Pradesh India Sep 13
Scopolamine Hydro Bromide Alkaloids Andrah Pradesh India Sep 13
Scopolamine Methyl Nitrate Alkaloids Andrah Pradesh India Sep 13
Diclofenac Sodium Amoli Vapi India Feb 14
Furosemide AMRI Maharashtra India Dec 15
Bromhexine HCl Amsa Como Italy Feb 14
Dropropizin Amsa Como Italy Mar 15
Etodolac Amsa Como Italy Mar 15
Glycopyrrolate / Glycopyrronium Bromide Amsa Como Italy Feb 14
Meloxicam Amsa Como Italy Feb 14
Memantine HCl Amsa Como Italy Feb 14
Metoclopramide HCl Amsa Como Italy Mar 15
Nystatin Antibiotice Lasi Romania Oct 13
Miglustat Apicore Gujarat India Sep 13
Simethicone Basildon Abingdon UK Feb 15
Glucosamine HCl Bayir Bangalore India Feb 14
Ketoprofen BEC Chemicals Roha-Dist. India May 16
Ketoprofen Bidachem Fornovo Italy Apr 13
Ferric Hydroxide Polymaltose Biofer Medolla Italy Nov 13
Amiloride HCl Bioindustria Fresonara Italy Apr 16
Baclofen Bioindustria Fresonara Italy Apr 16
Indapamide Bioindustria Fresonara Italy Apr 16
Levodropropizine Bioindustria Fresonara Italy Apr 16
Prazosin Bioindustria Fresonara Italy Apr 16
Triprolidine Bioindustria Fresonara Italy Apr 16
Phenoxymethylpenicillin Potassium Biotika Slovenska Lupca Slovakia Dec 15
Nystatin Micronised Capua BioServices (former DSM Capua) Capua Italy Feb 16
Benzocaine Changzhou Sunlight Changzhou City China Jun 16
Norephedrine ChengFong Dayuan Taiwan Mar 15
Amlodipine Mesylate Monohydrate Cipla Kurkumbh/Bangalore India Sep 14
Estramustine sodium phosphate Coral Drugs New Delhi India Sep 15
Fluticasone Propionate Coral Drugs New Delhi India Sep 15
Salmeterol Xinafoate Coral Drugs New Delhi India Sep 15
Amisulpride Cosma Ciserano Italy Feb 14
Carprofen Cosma Ciserano Italy Feb 14
Hydroxyzine HCl Cosma Ciserano Italy Feb 14
Hydroxyzine Pamoate Cosma Ciserano Italy Feb 14
Ketoprofen Cosma Ciserano Italy Mar 15
Labetalol HCl Cosma Ciserano Italy Feb 14
Pantethine 80% Cosma Ciserano Italy Feb 14
Propranolol HCl Cosma Ciserano Italy Feb 14
Pyrantel Pamoate Cosma Ciserano Italy Mar 15
Pyrantel Pamoate / Pyrantel Embonate Cosma Ciserano Italy Feb 14
Ranolazine Cosma Ciserano Italy Feb 14
Sulfinpyrazone Cosma Ciserano Italy Mar 15
Torasemide Cosma Ciserano Italy Mar 15
Glucose CSPC Shengxue Glucose Shijiazhuang China Feb 14
Terbinafine HCl Derivados Quimicos Alcantarilla Spain Feb 15
Cilostazol Dipharma Francis Mereto di Tomba Italy May 14
Isorbide Nitrates Dipharma Francis Mereto di Tomba Italy May 14
Bisacodyl Dishman Ahmedabad India Apr 13
Octenidine HCl Dishman Ahmedabad India Sep 13
Ketoprofen DongBang Gyeonggi-do Korea Mar 15
Neostigmine Bromide DPx Fine Chemicals Linz Austria Jun 16
Neostigmine Methylsulfat DPx Fine Chemicals Linz Austria Jun 16
Pyridostigmine Bromide DPx Fine Chemicals Linz Austria Jun 16
Silver Sulfadiazine DPx Fine Chemicals Linz Austria Jun 16
Permethrin Dr Reddys Mirfield UK Nov 13
Amoxicillin DSM Toansa India Aug 15
Flucloxacillin Sodium DSM Toansa India Aug 15
Ascorbic Acid DSM Nutritional Products Dalry UK Jun 16
Calcium-D-Pantothenate DSM Nutritional Products Dalry UK Jun 16
Cholecalciferol / Vitamin D3 crystalline DSM Nutritional Products Sisseln / Village-Neuf Switzerland / France Oct 14
Coated Ascorbic Acid DSM Nutritional Products Dalry UK Jun 16
Cyanocobalamin / Vitamin B12 DSM Nutritional Products Sisseln Switzerland Oct 14
D-Biotin DSM Nutritional Products Sisseln / Village-Neuf Switzerland / France Oct 14
D-Panthenol DSM Nutritional Products Dalry UK Jun 16
DL-a-Tocopherol / Vitamin E DSM Nutritional Products Sisseln Switzerland Oct 14
Flunitrazepam DSM Nutritional Products Sisseln Switzerland Oct 14
Folic Acid / Vitamin B9 DSM Nutritional Products Sisseln Switzerland Oct 14
Moclobemide DSM Nutritional Products Sisseln Switzerland Oct 14
Phytomenadion / Vitamin K1 DSM Nutritional Products Sisseln Switzerland Oct 14
Pyridoxine HCl DSM Nutritional Products Grenzach Germany Jul 16
Retinol Palmitate / Vitamin A DSM Nutritional Products Sisseln Switzerland Oct 14
Riboflavin 5`-Phosphate Sodium / Vitamin B2 DSM Nutritional Products Sisseln / Village-Neuf Switzerland / France Oct 14
Riboflavin tablet grade DSM Nutritional Products Grenzach Germany Jul 16
Riboflavin Universal DSM Nutritional Products Grenzach Germany Jul 16
Sodium Ascorbate, Crystalline DSM Nutritional Products Dalry UK Jun 16
Thiamine HCl DSM Nutritional Products Grenzach Germany Jul 16
Thiamine Mononitrate DSM Nutritional Products Grenzach Germany Jul 16
Vitamin D3 crude DSM Nutritional Products Grenzach Germany Jul 16
Vitamin D3 dry formulations DSM Nutritional Products Sisseln Switzerland Oct 14
Amoxicillin Trihydrate DSM Sinochem (Deretil) Almeria Spain Apr 16
Erythromycin Base Ercros Aranjuez Spain May 16
Erythromycin Ethylsuccinate Ercros Aranjuez Spain May 16
Acebutolol HCl Erregierre San Paolo d'Argon Italy Jun 14
Ambroxol HCl Erregierre San Paolo d`Argon / Sovere Italy Jun 14
Bisacodyl Erregierre San Paolo d'Argon Italy Jun 14
Clotrimazole Erregierre San Paolo d`Argon / Sovere Italy Jun 14
Fluoxetine Erregierre San Paolo d`Argon / Sovere Italy Jun 14
Isocoazole Nitrate Erregierre San Paolo d`Argon / Sovere Italy Jun 14
Moclobemide Erregierre San Paolo d`Argon / Sovere Italy Jun 14
Pirlindole HCI Erregierre San Paolo d’Argon, Sovere Italy Jun 14
Sulconazole Nitrate Erregierre San Paolo d'Argon Italy Jun 14
Ticlopidine HCl Erregierre San Paolo d`Argon / Sovere Italy Jun 14
Tioconazole Erregierre San Paolo d`Argon / Sovere Italy Jun 14
Chlortalidone Euticals Orrigio Italy Dec 13
Alpha-ketoglutaric acid Evonik Ham France Jul 15
Ketoglutaric acid Evonik Ham France Jul 15
L-Arginine-L-Aspartate Evonik Ham France Jul 15
L-Glutamic acid Evonik Ham France Jul 15
L-Lysine H2O Evonik Ham France Jul 15
L-Lysine HCI Evonik Ham France Jul 15
L-Threonine Evonik Ham France Jul 15
N-Acetyl-DL-Methionine Evonik Ham France Jul 15
Ornithin L-Aspartat Evonik Ham France Jan 14
Chlorhexidine Digluconate solution 20% Evonik Hanau Hanau Germany Oct 14
DL-Methionine Evonik Rexim Nanning China May 15
Glycine Evonik Rexim Nanning China May 15
L-Aspartic Acid Evonik Rexim Nanning China May 15
L-Isoleucine Evonik Rexim Nanning China May 15
L-Leucine Evonik Rexim Nanning China May 15
L-Methionine Evonik Rexim Nanning China May 15
L-Valine Evonik Rexim Nanning China May 15
Lorazepam Evonik Technochemie Dossenheim Germany Jun 16
Alfuzosin HCl Excella Feucht Germany Jul 15
Anastrozole Excella Feucht Germany May 16
Baclofen Excella Feucht Germany Jul 15
Bupivacaine HCI Excella Feucht Germany Jul 15
Buspirone HCI Excella Feucht Germany Jul 15
Busulfan Excella Feucht Germany May 16
Cevimeline HCl Excella Feucht Germany May 16
Deracoxib Excella Feucht Germany Jul 15
Dobutamine HCI Excella Feucht Germany Jul 15
Doxazosin Mesilate Excella Feucht Germany May 16
Haloperidol Excella Feucht Germany Jul 15
Levothyroxine Sodium Excella Feucht Germany Jul 15
Methotrexate Excella Feucht Germany Jul 15
Methotrexate Sodium Excella Feucht Germany Jul 15
Mianserin HCl Excella Feucht Germany May 16
R-Baclofen Excella Feucht Germany May 16
Tamoxifen Citrate Excella Feucht Germany May 16
Timolol Maleate Excella Feucht Germany May 16
Crataegi dry extract Extraktchemie Stadthagen Germany Jun 14
Liquiritae radix dry extract Extraktchemie Stadthagen Germany Jun 14
Pelargonium dry extract Extraktchemie Stadthagen Germany Jun 14
Metronidazole Farchemia Treviglio Italy Apr 14
Cinnarizine FDC Roha India Dec 13
Miconazole Nitrate FDC Roha India Mar 14
Timolol Maleate FDC Roha India Mar 14
Extracts Finzelberg Andernach Germany Nov 15
Herbal Extracts Finzelberg Andernach Germany Oct 13
Indometacin FIS Fabbrica Italiana Termoli Italy Sep 13
Cyanocobalamin / Vitamin B12 Hebei Huarong Shijiazhuang China Jun 14
Pyridostigmine Hydrobromide Helsinn Advanced Synthesis Biasca Switzerland Dec 14
Pantoprazole Hetero Drugs Hyderabad India Sep 13
Cinnarizine HIKAL Bangalore India Jun 13
Ibuprofen Hubei Biocause Jingmen City China Oct 14
Magnesium Hydroxide ICL (Dead Sea) Mishor Rotem Israel Dec 13
Magnesium Oxide ICL (Dead Sea) Mishor Rotem Israel Dec 13
Magnesium Oxide Granulated Form ICL (Dead Sea) Mishor Rotem Israel Dec 13
Magnesium Oxide Pharmaceutical Grade ICL (Dead Sea) Mishor Rotem Israel Dec 13
Ifosfamide Ifotam Lodz Poland Nov 13
Diegonest Industriale Chimica Saronno Italy Dec 15
Atenolol IPCA Ratlam India Apr 16
Furosemide IPCA Ratlam India Apr 16
Methylphenidate HCl IPCA Ratlam India Apr 16
Picactif Medicinal EP 40 Jacobi Carbons Vierzon France Jun 15
Amidotrizoic Acid Dihydrate Justesa Imagen Coslada Spain May 13
Natrium Valporate Katwijk Chemie Katwijk Netherlands Nov 13
Phenytoin Natrium Katwijk Chemie Katwijk Netherlands Nov 13
Atenolol Kopran Maharashtra India Jul 13
Roxithromycin Kopran Maharashtra India Jul 13
Alprazolam Lake Chemicals Bangalore India Dec 15
Amisulpride Lebsa Cornellà Spain Jun 16
Betahistine Dimesilate Lebsa Cornellà Spain Jun 16
Betahistine HCl Lebsa Cornellà Spain Jun 16
Dequalinium Chloride Lebsa Cornellà Spain Jun 16
Sulpiride Lebsa Cornellà Spain Jun 16
Cyclizine HCl Micro Labs Bangalore India Mar 14
Carbocisteine Lysinat Moehs BCN Castelbisball Spain Apr 15
Lidocaine Base Moehs BCN Castelbisball Spain Apr 15
Acetylcysteine Moehs Catalana Rubi (Barcelona) Spain Apr 15
Bisoprolol Fumarate Moehs Catalana Rubi (Barcelona) Spain Apr 15
Carbocisteine Moehs Catalana Rubi (Barcelona) Spain Jan 14
Carvedilol Moehs Catalana Rubi (Barcelona) Spain Apr 15
Lidocaine HCl Moehs Catalana Rubi (Barcelona) Spain Apr 15
Mepivacain HCl Moehs Catalana Rubi (Barcelona) Spain Apr 15
Metoprolol Tartrate Moehs Catalana Rubi (Barcelona) Spain Jan 14
Pyrantel Embonate Moehs Catalana Rubi (Barcelona) Spain Jan 14
Sotalol HCl Moehs Catalana Rubi (Barcelona) Spain Apr 15
Triamterene Moehs Catalana Rubi (Barcelona) Spain Jan 14
Fenofibrate Moehs Coprima Polinyà Spain Apr 15
Rizatriptan Benzoate Natco Pharma Mekaguda India Mar 16
Sertraline HCl Natco Pharma Mekaguda India Mar 16
Sumatriptan Succinate Natco Pharma Mekaguda India Mar 16
Zolmitriptan Natco Pharma Mekaguda India Mar 16
Nettle Leaf Extract Naturex Caronno Pertusella Italy Jun 15
Ascorbic Acid Northeast Pharm. Shenyang China May 15
Piracetam Northeast Pharm. Shenyang China Nov 15
Benzalkonium chloride Novo Nordisk Pharmatech Koge Denmark Jan 16
Benzalkonium chloride solution Novo Nordisk Pharmatech Koge Denmark Jan 16
Aciclovir Olon Dorno Italy Feb 14
Ibuprofen D, L Lysine Olon Dorno Italy Feb 14
Bezafibrate Olon ex Fidia Solmag Italy Jun 13
Pridinol Methansulfonate Anhydrous Olon ex Fidia Garbagnate Italy Nov 13
Tretinoin Olon ex Fidia Garbagnate Italy Nov 13
Perazine Maloate OM Pharm. Industries Tarapur, Boisar India Sep 13
Ciclopirox PCAS Turku Finland Apr 14
Ciclopirox Olamine PCAS Limay France Jan 14
Glycopyrrolate / Glycopyrronium Bromide PCAS Turku Finland Apr 14
6-Methyluracil PharmaZell Chennai India Apr 15
Acetylcysteine PharmaZell Raubling Germany Feb 14
Mesalamine PharmaZell Raubling Germany Feb 14
Ferrous Fumerate Polydrugs Ambernath India Sep 14
Tramadol HCl Proto Chemicals Mitlödi Switzerland Feb 16
(S)-Lactic Acid Purac Bioquimica Montmeló (BCN) Spain Jun 15
Sodium (S)-Lactate 50% and 60% solution PURAC Bioquímica Montmeló (BCN) Spain Jun 15
Aciclovir Recordati Campoverde Italy Dec 14
Dimenhydrinate Recordati Campoverde Italy Dec 14
Diphenhydramine HCl Recordati Campoverde Italy Dec 14
Dobutamine HCl Recordati Campoverde Italy Dec 14
Dopamine HCl Recordati Campoverde Italy Dec 14
Ketorolac Tromethamine Recordati Campoverde Italy Dec 14
Manidipine Dihydrochloride Recordati Campoverde Italy Dec 14
Mebeverine HCl Recordati Campoverde Italy Dec 14
Papaverine HCl Recordati Campoverde Italy Dec 14
Phenytoin Sodium Recordati Campoverde Italy Dec 14
Verapamil HCl Recordati Campoverde Italy Dec 14
Amlodipine Besylate Richter Themis Medicare Gujarat India Oct 13
Sodium Chloride Salinen Ebensee Austria Oct 14
Polidocanol Schärer & Schläpfer Rothrist Switzerland Sep 14
Albendazole Sequent Mahad India Feb 15
Caffeine Shandong Xinhua Shandong China Oct 14
Metamizole Sodium Monohydrate Shandong Xinhua Shandong China Dec 14
Propyphenazone Shandong Xinhua Shandong China Dec 14
Senna Leaf Dry Extract Shashi Rajasthan India Aug 14
Ambroxol HCI Shilpa Medicare Hyderabad India Sep 15
Gemcitabin HCI Shilpa Medicare Hyderabad India Sep 15
Citalopram Shodhana Hyderabad India Mar 13
Acemetacin Siegfried Zofingen Switzerland Jan 16
Fluoxetine Siegfried Zofingen Switzerland Oct 14
Methadone Siegfried Zofingen Switzerland Oct 14
Morphine Sulfate Siegfried Zofingen Switzerland Jan 16
Naltrexone Siegfried Zofingen Switzerland Oct 14
Nicotine Base Siegfried Zofingen Switzerland Jan 16
Oxiconazole Siegfried Zofingen Switzerland Oct 14
Primidone Siegfried Zofingen Switzerland Oct 14
Amiloride HCl Sifavitor Casaletto Italy May 15
Amitriptyline HCl Sifavitor Casaletto Italy Dec 13
Benperidol Sifavitor Casaletto Italy May 15
Clidinium Bromide Sifavitor Casaletto Italy Dec 13
Miconazole Nitrate Sifavitor Cassaletto Italy Dec 13
Norfloxacin Smruthi Organics Solapur India Mar 13
Benserazide HCl SP Quimica Tarragona Spain Nov 15
Diethylamine Salicylate SP Quimica Tarragona Spain Nov 15
Furosemide Sri Krishna Jinnaram Mandal India Oct 15
Glibenclamide Sri Krishna Jinnaram Mandal India Oct 15
Chlormadinone Acetate Sterling Solomeo di Corciano Italy Oct 13
Fluticasone Propionate Sterling Solomeo di Corciano Italy Oct 13
Halometasone Monohydrate Sterling Solomeo di Corciano Italy Oct 13
Dexamethasone Isonicotinate Steroid Cologno Monzese Italy Jul 15
Chlorphenamine Maleate Supriya Lifescience Taluka-Khed India May 16
Linezolid Symed Hyderabad India Dec 14
Benzyl Benzoate Symrise Holzminden Germany Nov 14
Colours Symrise Holzminden Germany Sep 15
Dragosantol Symrise Holzminden Germany Apr 13
Flavours Symrise Holzminden Germany Sep 15
Flavours Symrise Holzminden Germany Apr 13
Levomenthol Symrise Holzminden Germany Nov 14
Menthol Symrise Holzminden Germany Nov 14
Racemic Menthol Symrise Holzminden Germany Nov 14
Thymol Symrise Holzminden Germany Nov 14
Silymarin TEVA Opava Czech Republic Mar 14
Diltiazem HCl TEVA (Abic) Netanya Israel Apr 14
Hydrochlorothiazide TEVA (Abic) Netanya Israel Apr 14
Carbidopa TEVA (Assia) Beer Sheva Israel Apr 14
Furosemide TEVA (Assia) Beer Sheva Israel Apr 14
Gabapentin TEVA (Assia) Beer Sheva Israel Apr 14
Levofloxacin TEVA (Assia) Beer Sheva Israel Apr 14
Probenecide TEVA (Assia) Beer Sheva Israel Apr 14
Rosuvastatin Calcium TEVA (Assia) Beer Sheva Israel Apr 14
Allopurinol TEVA (Plantex) Netanya Israel Apr 14
Amitriptyline HCl TEVA (Plantex) Netanya Israel Apr 14
Carbamazapine TEVA (Plantex) Netanya Israel Apr 14
Doxepine HCl TEVA (Plantex) Netanya Israel Apr 14
Hydrochlorothiazide TEVA (Plantex) Netanya Israel Apr 14
Pentoxifylline TEVA (Plantex) Netanya Israel Apr 14
Trimethoprim TEVA (Plantex) Netanya Israel Apr 14
Betamethasone Valerate TEVA (Sicor) Rho Italy Dec 15
Budesonide TEVA (Sicor) Santhia Italy Mar 14
Triamcinolone Acetonide TEVA (Sicor) Rho Italy Dec 15
Bendroflumethiazide Unichem Dhatav-Roha India Dec 13
Lisinopril Dihydrate Unimark Remedies Gujarat India Dec 15
Ramipril Unimark Remedies Vapi India Apr 12
Chlormadinone Acetate Valdepharm Val de Reuil France Jun 16
Estradiol Benzoate Valdepharm Val de Reuil France Jun 16
Estradiol Hemihydrate Valdepharm Val de Reuil France Jun 16
Estradiol Valerat Valdepharm Val de Reuil France Jun 16
Ethinyl Estradiol Valdepharm Val de Reuil France Jun 16
Norethisterone Valdepharm Val de Reuil France Jun 16
Norethisterone Acetate Valdepharm Val de Reuil France Jun 16
Ambroxol HCl Ven PetroChem Sarigam India Jan 13
Gramicidin Xellia Budapest Hungary Oct 13
Tyrothricin Xellia Budapest Hungary Oct 13
Bacitracin Xellia Pharm Taizhou China Feb 16
Bacitracin Zn Xellia Pharm Taizhou China Feb 16
Vancomycin HCl Xellia Pharm Taizhou China Feb 16
Acetylcysteine ZaCH System Vicenza Italy Mar 16
Enalapril Maleate Zhejiang Huahai Linhai China Nov 14
Carbamazepine Zhejiang Jiuzhou (new site) Taizhou China Jul 13
Bezafibrate Zhejiang Juizhou Taizhou City China Nov 14
Cyproterone Acetate micronized Zhejiang Xianju Xianju China Feb 15
Amoxicillin Zhuhai Laboratories Guandong China Jun 14

 

Las auditorías para el cumplimiento GMP son sujetas a un acuerdo de confidencialidad con el fabricante. Obtenemos el consentimiento del fabricante antes de distribuir el informe de auditoría.

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