Relatórios de auditoria de API disponíveis

Diapharm coordena auditorias API de terceira parte no mundo todo para avaliar a conformidade de substâncias de base, excipientes e substâncias activas farmacêuticas (API) com Boas Práticas de Fabricação (GMP). Superamos a marca de 500 relatórios atuais de auditoria de APIs.

As auditorias são realizadas por auditores de um organismo de inspecção independente e credenciado ISO 17020 (tipo A). A acreditação garante o mais alto nível de excelência, independência e aceitação dos relatórios de auditoria por parte das autoridades.

Nossos serviços

  • Relatórios de auditoria abrangentes.
  • Tratamentos dos desvios (avaliação das acções correctivas e preventivas).
  • CV dos auditores.
  • Coordenação dos requisitos (aprovação do fabricante, acordo de confidencialidade, etc)


Contate-nos para mais informações sobre relatórios de auditoria: auditsNOSPAM@diapharm.com!

Lista dos Relatórios de Auditoria

API molecule Manufacturer Town Country Date
Ramipril Aarti Industries Palghar India 2017-02
Cefaclor Monohydrate ACS Dobfar Vimercate Italy 2017-06
Cefadroxil Monohydrate ACS Dobfar Vimercate Italy 2017-06
Cefalexine Monohydrate ACS Dobfar Vimercate Italy 2017-06
Cefprozil Monohydrate ACS Dobfar Vimercate Italy 2017-06
Cefradine Monohydrate ACS Dobfar Vimercate Italy 2017-06
Vinblastine Sulfate Ajinomoto Omnichem Wetteren / Louvian-La-Neuve Belgium 2014-11
Vincristine Sulfate Ajinomoto Omnichem Wetteren / Louvian-La-Neuve Belgium 2014-11
Vindesine Sulfate Ajinomoto Omnichem Wetteren / Louvian-La-Neuve Belgium 2014-11
Hyoscine Alchem Faridabad India 2015-01
Hyoscine Butyl Bromide Alkaloids Telangana India 2016-10
Hyoscine Hydro Bromide Alkaloids Telangana India 2016-10
Clotrimazole Amoli Vapi India 2017-01
Diclofenac Sodium Amoli Vapi India 2017-01
Furosemide AMRI Maharashtra India 2015-12
Bromhexine HCl Amsa Como Italy 2017-03
D,L Dropropizine Amsa Como Italy 2017-03
Etodolac Amsa Como Italy 2017-03
Flecainide Acetate Amsa Como Italy 2017-03
Glipizide Amsa Como Italy 2017-03
Meloxicam Amsa Como Italy 2017-03
Memantine HCl Amsa Como Italy 2017-03
Metoclopramide Amsa Como Italy 2017-03
Acetylsalicylic acid Andhra Sugars Tanuku India 2017-09
Nystatin Antibiotice Iasi Romania 2016-11
Ethacrynic Acid Apicore Gujarat India 2017-03
Miglustat Apicore Gujarat India 2017-03
Desogestrel Aspen Oss Netherlands 2017-02
Estradiol Aspen Oss Netherlands 2017-02
Estradiol Valerate Aspen Oss Netherlands 2017-02
Estriol Aspen Oss Netherlands 2017-02
Ethinyl Estradiol Aspen Oss Netherlands 2017-02
Norenthindrone Acetate Aspen Oss Netherlands 2017-02
Norethindrone Aspen Oss Netherlands 2017-02
Progesterone Aspen Oss Netherlands 2017-02
Testosterone Aspen Oss Netherlands 2017-02
Simethicone Basildon Abingdon UK 2015-02
Ketoprofen BEC Chemicals Roha-Dist. India 2016-05
Amiloride HCl Bioindustria Fresonara Italy 2016-04
Baclofen Bioindustria Fresonara Italy 2016-04
Indapamide Bioindustria Fresonara Italy 2016-04
Levodropropizine Bioindustria Fresonara Italy 2016-04
Prazosin Bioindustria Fresonara Italy 2016-04
Triprolidine Bioindustria Fresonara Italy 2016-04
Phenoxymethylpenicillin Potassium Biotika Slovenska Lupca Slovakia 2015-12
Camphor Camphor & Allied Bereilly India 2016-12
Nystatin Micronised Capua BioServices (former DSM Capua) Capua Italy 2016-02
Benzocaine Changzhou Sunlight Changzhou City China 2016-06
Dimenhydrinate Chemische Fabrik Berg Bitterfeld-Wolfen Germany 2016-12
Polidocanol 600 Chemische Fabrik Schärer & Schläpfer Rothrist Switzerland 2016-11
Norephedrine ChengFong Dayuan Taiwan 2015-03
Amlodipine Mesylate Monohydrate Cipla Kurkumbh/Bangalore India 2014-09
Estramustine sodium phosphate Coral Drugs New Delhi India 2015-09
Fluticasone Propionate Coral Drugs New Delhi India 2015-09
Salmeterol Xinafoate Coral Drugs New Delhi India 2015-09
Calcium Lactate Pentahydrate (PURACAL PP/USP) Corbion Purac Gorinchem Netherlands 2016-09
Sodium (S)-Lactate 50% solution (PURASAL S/PF 50 %) Corbion Purac Gorinchem Netherlands 2016-09
Bethanechol Chloride Corden Pharma Bergamo Treviglio Italy 2017-03
Metronidazole Corden Pharma Bergamo Treviglio Italy 2017-03
Amisulpride Cosma Ciserano Italy 2017-07
Ketoprofen Cosma Ciserano Italy 2015-03
Pyrantel Pamoate Cosma Ciserano Italy 2015-03
Sulfinpyrazone Cosma Ciserano Italy 2015-03
Cefixime Covalent Telangana India 2017-01
Ceftibuten Covalent Telangana India 2017-01
Indomethacin CSPC OUYI Pharmaceutical Shijiazhuang China 2017-07
Xylometazolin Hydrochloride CTX LIFESCIENCES Gurajat India 2016-10
Terbinafine HCl Derivados Quimicos Alcantarilla Spain 2015-02
Aminocaproic Acid Dipharma Francis Baranzate Italy 2017-05
Cilostazol Dipharma Francis Mereto di Tomba Italy 2017-05
Isorbide Nitrates Dipharma Francis Mereto di Tomba Italy 2017-05
DOTA Dishman Ahmedabad India 2017-06
Iopamidol Divi's Laboratories Andhra Pradesh India 2017-07
Ketoprofen DongBang Gyeonggi-do Korea 2015-03
Neostigmine Bromide DPx Fine Chemicals Linz Austria 2016-06
Neostigmine Methylsulfat DPx Fine Chemicals Linz Austria 2016-06
Pyridostigmine Bromide DPx Fine Chemicals Linz Austria 2016-06
Silver Sulfadiazine DPx Fine Chemicals Linz Austria 2016-06
Permethrin Dr. Reddy´s Laboratories Mirfield England 2016-10
Amoxicillin DSM Toansa India 2015-08
Flucloxacillin Sodium DSM Toansa India 2015-08
Ascorbic Acid DSM Nutritional Products Belvidere USA 2017-07
Ascorbic Acid DSM Nutritional Products Dalry UK 2016-06
Calcium-D-Pantothenate DSM Nutritional Products Dalry UK 2016-06
Cholecalciferol / Vitamin D3 crystalline DSM Nutritional Products Sisseln / Village-Neuf Switzerland / France 2017-06
Coated Ascorbic Acid DSM Nutritional Products Dalry UK 2016-06
Cyanocobalamin / Vitamin B12 DSM Nutritional Products Sisseln Switzerland 2017-06
D-Biotin DSM Nutritional Products Sisseln / Village-Neuf Switzerland / France 2017-06
DL-a-Tocopherol / Vitamin E DSM Nutritional Products Sisseln Switzerland 2017-06
D-Panthenol DSM Nutritional Products Dalry UK 2016-06
Dry Vitamin E DSM Nutritional Products Belvidere USA 2017-07
Flunitrazepam DSM Nutritional Products Sisseln Switzerland 2017-06
Folic Acid / Vitamin B9 DSM Nutritional Products Sisseln Switzerland 2017-06
Moclobemide DSM Nutritional Products Sisseln Switzerland 2017-06
Nicotinamide DSM Nutritional Products Belvidere USA 2017-07
Phytomenadion / Vitamin K1 DSM Nutritional Products Sisseln Switzerland 2017-06
Pyridoxine HCl DSM Nutritional Products Grenzach Germany 2016-07
Pyridoxine Hydrochloride DSM Nutritional Products Belvidere USA 2017-07
Retinol Palmitate / Vitamin A DSM Nutritional Products Sisseln Switzerland 2017-06
Riboflavin DSM Nutritional Products Belvidere USA 2017-07
Riboflavin 5`-Phosphate Sodium / Vitamin B2 DSM Nutritional Products Sisseln / Village-Neuf Switzerland / France 2017-06
Riboflavin tablet grade DSM Nutritional Products Grenzach Germany 2016-07
Riboflavin Universal DSM Nutritional Products Grenzach Germany 2016-07
Sodium Ascorbate, Crystalline DSM Nutritional Products Dalry UK 2016-06
ß-Carotene DSM Nutritional Products Sisseln / Village-Neuf Switzerland / France 2017-06
Thiamine HCl DSM Nutritional Products Grenzach Germany 2016-07
Thiamine Mononitrate DSM Nutritional Products Grenzach Germany 2016-07
Vitamin A Acetate DSM Nutritional Products Belvidere USA 2017-07
Vitamin B6 DSM Nutritional Products Xinghuo China 2017-09
Vitamin D3 DSM Nutritional Products Belvidere USA 2017-07
Vitamin D3 crude DSM Nutritional Products Grenzach Germany 2016-07
Vitamin D3 dry formulations DSM Nutritional Products Sisseln Switzerland 2017-06
Amoxicillin Trihydrate DSM Sinochem (Deretil) Almeria Spain 2016-04
Cefadroxil Monohydrate DSM Sinochem (Santa Perètua de Mogoda) Barcelona Spain 2016-09
Cefalexin Monohydrate DSM Sinochem (Santa Perètua de Mogoda) Barcelona Spain 2016-09
Cefradine DSM Sinochem (Santa Perètua de Mogoda) Barcelona Spain 2016-09
Erythromycin Base Ercros Aranjuez Spain 2016-05
Erythromycin Ethylsuccinate Ercros Aranjuez Spain 2016-05
Ambroxol HCl Erregierre San Paolo d'Argon / Sovere Italy 2017-04
Amisulpride Erregierre San Paolo d'Argon / Sovere Italy 2017-04
Bisacodyl Erregierre San Paolo d'Argon / Sovere Italy 2017-04
Ciclopirox Olamine Erregierre San Paolo d'Argon / Sovere Italy 2017-04
Clotrimazole Erregierre San Paolo d'Argon / Sovere Italy 2017-04
Gabapentin Erregierre San Paolo d'Argon / Sovere Italy 2017-04
Isoconazole Nitrate Erregierre San Paolo d'Argon / Sovere Italy 2017-04
Rececadotril Erregierre San Paolo d'Argon / Sovere Italy 2017-04
Rivastigmine Erregierre San Paolo d'Argon / Sovere Italy 2017-04
Rivastigmine Tartrate Erregierre San Paolo d'Argon / Sovere Italy 2017-04
Sulconazole Nitrate Erregierre San Paolo d'Argon / Sovere Italy 2017-04
Ticlopidine HCl Erregierre San Paolo d'Argon / Sovere Italy 2017-04
Tioconazole Erregierre San Paolo d'Argon / Sovere Italy 2017-04
Alpha-ketoglutaric acid Evonik Ham France 2017-09
Ketoglutaric acid Evonik Ham France 2017-09
L-Arginine-L-Aspartate Evonik Ham France 2017-09
L-Glutamic acid Evonik Ham France 2017-09
L-Lysine H2O Evonik Ham France 2017-09
L-Lysine HCI Evonik Ham France 2017-09
L-Threonine Evonik Ham France 2017-09
N-Acetyl-DL-Methionine Evonik Ham France 2017-09
Ornithin L-Aspartat Evonik Ham France 2017-09
Chlorhexidine Digluconate solution 20% Evonik Hanau Hanau Germany 2017-02
DL-Methionine Evonik Rexim Nanning China 2015-05
Glycine Evonik Rexim Nanning China 2015-05
L-Aspartic Acid Evonik Rexim Nanning China 2015-05
L-Isoleucine Evonik Rexim Nanning China 2015-05
L-Leucine Evonik Rexim Nanning China 2015-05
L-Methionine Evonik Rexim Nanning China 2015-05
L-Valine Evonik Rexim Nanning China 2015-05
Lorazepam Evonik Technochemie Dossenheim Germany 2016-06
Adapalene Excella Feucht Germany 2017-05
Alfuzosin HCl Excella Feucht Germany 2015-07
Anastrozole Excella Feucht Germany 2017-05
Baclofen Excella Feucht Germany 2015-07
Bupivacaine HCI Excella Feucht Germany 2015-07
Buspirone HCI Excella Feucht Germany 2017-05
Busulfan Excella Feucht Germany 2016-05
Capecitabine Excella Feucht Germany 2017-05
Cevimeline HCl Excella Feucht Germany 2016-05
Deracoxib Excella Feucht Germany 2015-07
Dobutamine HCI Excella Feucht Germany 2015-07
Doxazosin Mesilate Excella Feucht Germany 2017-05
Ganciclovir Excella Feucht Germany 2017-05
Haloperidol Excella Feucht Germany 2017-05
Levothyroxine Sodium Excella Feucht Germany 2017-05
Methotrexate Excella Feucht Germany 2015-07
Methotrexate Sodium Excella Feucht Germany 2015-07
Mianserin HCl Excella Feucht Germany 2017-05
R-Baclofen Excella Feucht Germany 2016-05
Tamoxifen Citrate Excella Feucht Germany 2016-05
Temozolomide Excella Feucht Germany 2017-05
Timolol Maleate Excella Feucht Germany 2016-05
Trazodone HCl Excella Feucht Germany 2017-05
Bromhexine Hydrochloride FDC Roha India 2017-04
Cinnarizine FDC Roha India 2017-04
Miconazole Nitrate FDC Roha India 2017-04
Timolol Maleate FDC Roha India 2017-04
Diltiazem Hydrochloride Fermion Oy Hanko Finland 2017-05
Extracts Finzelberg Andernach Germany 2017-05
Sirolimus (Rapamycin) Fujian Kerui Pharmaceutical Fuzhou China 2016-07
Zink Oxid Pharma Grades Grillo Zinkoxid Goslar Germany 2017-05
Estriol Hapila Gera Germany 2017-04
Cyanocobalamin / Vitamin B12 Hebei Huarong Shijiazhuang China 2017-07
Pyridostigmine Hydrobromide Helsinn Advanced Synthesis Biasca Switzerland 2014-12
Ibuprofen Hubei Biocause Jingmen City China 2014-10
Magnesium Carbonate ICL (Dead Sea) Mishor Rotem Israel 2016-08
Magnesium Hydroxide ICL (Dead Sea) Mishor Rotem Israel 2016-08
Magnesium Oxide ICL (Dead Sea) Mishor Rotem Israel 2016-08
Ifosfamide Ifotam Lodz Poland 2016-09
Diegonest Industriale Chimica Saronno Italy 2015-12
Atenolol IPCA Ratlam India 2016-04
Famotidine IPCA Ankleshwar India 2016-12
Furosemide IPCA Ratlam India 2016-04
Methylphenidate HCl IPCA Ratlam India 2016-04
Picactif Medicinal EP 40 Jacobi Carbons Vierzon France 2015-06
Dehydroepiandrosterone Jiangsu Jiaerke Jiangsu China 2016-09
Pregnenolone Jiangsu Jiaerke Jiangsu China 2016-09
Progesterone Jiangsu Jiaerke Jiangsu China 2016-09
Alprazolam Lake Chemicals Bangalore India 2015-12
Amisulpride Lebsa Cornellà Spain 2016-06
Betahistine Dimesilate Lebsa Cornellà Spain 2016-06
Betahistine HCl Lebsa Cornellà Spain 2016-06
Dequalinium Chloride Lebsa Cornellà Spain 2016-06
Sulpiride Lebsa Cornellà Spain 2016-06
Carbocisteine Lysinat Moehs BCN Castelbisball Spain 2015-04
Lidocaine Base Moehs BCN Castelbisball Spain 2015-04
Acetylcysteine Moehs Catalana Rubi (Barcelona) Spain 2015-04
Bisoprolol Fumarate Moehs Catalana Rubi (Barcelona) Spain 2015-04
Carbocisteine Moehs Catalana Rubi (Barcelona) Spain 2014-01
Carvedilol Moehs Catalana Rubi (Barcelona) Spain 2015-04
Lidocaine HCl Moehs Catalana Rubi (Barcelona) Spain 2015-04
Mepivacain HCl Moehs Catalana Rubi (Barcelona) Spain 2015-04
Metoprolol Tartrate Moehs Catalana Rubi (Barcelona) Spain 2014-01
Pyrantel Embonate Moehs Catalana Rubi (Barcelona) Spain 2014-01
Sotalol HCl Moehs Catalana Rubi (Barcelona) Spain 2015-04
Triamterene Moehs Catalana Rubi (Barcelona) Spain 2014-01
Fenofibrate Moehs Coprima Polinyà Spain 2015-04
Rizatriptan Benzoate Natco Pharma Mekaguda India 2016-03
Sertraline HCl Natco Pharma Mekaguda India 2016-03
Sumatriptan Succinate Natco Pharma Mekaguda India 2016-03
Zolmitriptan Natco Pharma Mekaguda India 2016-03
Nettle Leaf Extract Naturex Caronno Pertusella Italy 2015-06
Ascorbic Acid Northeast Pharm. Shenyang China 2015-05
Piracetam Northeast Pharm. Shenyang China 2015-11
Benzalkonium chloride Novo Nordisk Pharmatech Koge Denmark 2016-01
Benzalkonium chloride solution Novo Nordisk Pharmatech Koge Denmark 2016-01
Ciclopirox PCAS Turku Finland 2017-03
Glycopyrrolate / Glycopyrronium Bromide PCAS Turku Finland 2017-03
Promazine hydrochloride PCAS Turku Finland 2017-03
Iron Dextran 10% Solution Pharmacosmos Holbaek Denmark 2016-12
Iron Dextran 20% Solution Pharmacosmos Holbaek Denmark 2016-12
Iron Dextran Powder Pharmacosmos Holbaek Denmark 2016-12
6-Methyluracil PharmaZell Chennai India 2015-04
Ferrous Fumerate Polydrugs Ambernath India 2014-09
Testosterone Enanthate Proquina Veracruz Mexico 2017-10
Tramadol HCl Proto Chemicals Mitlödi Switzerland 2016-02
(S)-Lactic Acid Purac Bioquimica Montmeló (BCN) Spain 2015-06
Sodium (S)-Lactate 50% and 60% solution PURAC Bioquímica Montmeló (BCN) Spain 2015-06
Aciclovir Recordati Campoverde Italy 2017-09
Dimenhydrinate Recordati Campoverde Italy 2017-09
Diphenhydramine HCl Recordati Campoverde Italy 2017-09
Dobutamine HCl Recordati Campoverde Italy 2017-09
Dopamine HCl Recordati Campoverde Italy 2017-09
Ketorolac Tromethamine Recordati Campoverde Italy 2017-09
Manidipine Dihydrochloride Recordati Campoverde Italy 2017-09
Mebeverine HCl Recordati Campoverde Italy 2017-09
Methenamine HCl Recordati Campoverde Italy 2017-09
Papaverine HCl Recordati Campoverde Italy 2017-09
Phenytoin Recordati Campoverde Italy 2017-09
Phenytoin Sodium Recordati Campoverde Italy 2017-09
Verapamil HCl Recordati Campoverde Italy 2017-09
Amlodipine Besylate Richter Themis Medicare Gujarat India 2016-12
Sodium Chloride Salinen Ebensee Austria 2017-03
Levothyroxine Sodium Sandoz Kundl Austria 2017-03
Polidocanol Schärer & Schläpfer Rothrist Switzerland 2016-11
Albendazole Sequent Mahad India 2015-02
Caffeine Shandong Xinhua Shandong China 2014-10
Metamizole Sodium Monohydrate Shandong Xinhua Shandong China 2014-12
Propyphenazone Shandong Xinhua Shandong China 2014-12
Ambroxol HCI Shilpa Medicare Hyderabad India 2015-09
Gemcitabin HCI Shilpa Medicare Hyderabad India 2015-09
Acemetacin Siegfried Zofingen Switzerland 2017-08
Burprenorphin Base Siegfried Zofingen Switzerland 2017-08
Burprenorphin HCl Siegfried Zofingen Switzerland 2017-08
Fluoxetine Siegfried Zofingen Switzerland 2017-08
Methadone Siegfried Zofingen Switzerland 2017-08
Morphine Sulfate Siegfried Zofingen Switzerland 2017-08
Naloxon HCl Siegfried Zofingen Switzerland 2017-08
Naltrexone Siegfried Zofingen Switzerland 2017-08
Nicotine Siegfried Zofingen Switzerland 2017-08
Oxiconazole Siegfried Zofingen Switzerland 2017-08
Primidone Siegfried Zofingen Switzerland 2017-08
Amiloride HCl Sifavitor Casaletto Italy 2015-05
Benperidol Sifavitor Casaletto Italy 2015-05
Benserazide HCl SP Quimica Tarragona Spain 2015-11
Diethylamine Salicylate SP Quimica Tarragona Spain 2015-11
Calcium Carbonate Specialty Minerals Birmingham UK 2017-04
Furosemide Sri Krishna Jinnaram Mandal India 2015-10
Glibenclamide Sri Krishna Jinnaram Mandal India 2015-10
Abiraterone Acetate Sterling Chemical Birzebbugia Malta 2017-06
Estradiol 17-Valerate Steroid Cologno Monzese Italy 2017-04
Hydroxyprogesterone Caproate Steroid Cologno Monzese Italy 2017-04
Norethisterone Enanthate Steroid Cologno Monzese Italy 2017-04
Testosterone Enanthate Steroid Cologno Monzese Italy 2017-04
Testosterone Propionate Steroid Cologno Monzese Italy 2017-04
Testosterone Undecanoate Steroid Cologno Monzese Italy 2017-04
Chlorphenamine Maleate Supriya Lifescience Taluka-Khed India 2016-05
Testosteron Undecanoat Symbiotec Pharmalab Pithampur India 2017-05
Linezolid Symed Hyderabad India 2014-12
Benzyl Benzoate Symrise Holzminden Germany 2014-11
Colours Symrise Holzminden Germany 2015-09
Flavours Symrise Holzminden Germany 2015-09
Levomenthol Symrise Holzminden Germany 2014-11
Menthol Symrise Holzminden Germany 2014-11
Racemic Menthol Symrise Holzminden Germany 2014-11
Thymol Symrise Holzminden Germany 2014-11
Betamethasone Valerate TEVA (Sicor) Rho Italy 2015-12
Triamcinolone Acetonide TEVA (Sicor) Rho Italy 2015-12
Doxorubicin HCl Transo-Pharm Siek Germany 2016-11
Epirubicin HCl Transo-Pharm Siek Germany 2016-11
Vinorelbine tartrate Transo-Pharm Siek Germany 2016-11
Hydrochlorothiazide Unichem Roha China 2017-02
Lisinopril Dihydrate Unimark Remedies Gujarat India 2015-12
Chlormadinone Acetate Valdepharm Val de Reuil France 2016-06
Estradiol Benzoate Valdepharm Val de Reuil France 2016-06
Estradiol Hemihydrate Valdepharm Val de Reuil France 2016-06
Estradiol Valerat Valdepharm Val de Reuil France 2016-06
Ethinyl Estradiol Valdepharm Val de Reuil France 2016-06
Norethisterone Valdepharm Val de Reuil France 2016-06
Norethisterone Acetate Valdepharm Val de Reuil France 2016-06
Bacitracin Xellia Pharm Taizhou China 2016-02
Bacitracin Zn Xellia Pharm Taizhou China 2016-02
Vancomycin HCl Xellia Pharm Taizhou China 2016-02
Gramicidin Xellia Pharmaceuticals Budapest Hungary 2016-10
Tyrothricin Xellia Pharmaceuticals Budapest Hungary 2016-10
Vancomycin HCl Xellia Pharmaceuticals Budapest Hungary 2016-10
Acetylcysteine ZaCH System Vicenza Italy 2016-03
Enalapril Maleate Zhejiang Huahai Linhai China 2014-11
Carbamazapine Zhejiang Juizhou Taizhou City China 2017-02
Cyproterone Acetate micronized Zhejiang Xianju Xianju China 2015-02

 

As auditorias para o cumprimento GMP estão sujeitas a acordos assinados e válidos de confidencialidade com o fabricante auditado. Obtemos o consentimento do fabricante antes da distribuição  do relatório de auditoria.

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