PharmSol 对成品、原料药、中间体和关键起始物料(KSM)进行了完整的一系列审计,以确保 全球客户的产品安全和质量。PharmSol 拥有内部审计团队,审计官通过了各种认证,包括 APIC/CEFIC/ASQ CQA/IRCA 认证。PharmSol 是首批根据 EC 指令 2004/27/EC 对其欧洲客户进行 第三方 GMP 审计的公司之一。PharmSol 已在全球成功进行了 1000 多次 GMP 审计。

GMP 审计(QP 审计)

PharmSol 根据 ICH Q7、EudraLex 第 4 卷、美国联邦法规 21 章第 11 部分和 PIC/s 药品生产质
量管理规范指南(2017 年 1 月)对生产现场进行确认。

GLP/GCP/GDP 审计

除 GMP 审计外,PharmSol 集团还对研发和分析实验室、CRO、仓储和分发网络进行审计。

批量审计/共享审计

PharmSol 还提供独特的商业模式,通过这种模式,原料药、关键起始物料和辅料的生产商可
以显著减少第三方审计和后续 CAPA 的工作量。立即与我们联系,探索独特创新的批量审计
或共享审计业务模式。

质量尽职调查

PharmSol 集团提供质量尽职调查支持,帮助公司从合规和投资角度审查其厂房。

供应安全审计(EHS)

从环境管理的角度来看,EHS 审计的实施是一项重要内容。PharmSol 集团及其经认证的审计
官团队可协助公司进行 EHS 审计。

GMP 审计报告

按 Ctrl+F 搜索产品的特定名称

Products (API/KSM/Intermediate) Country Select Report
10-Deacetyl Baccatin III (Intermediate) China
1-chloro-3,5-dimethyladamantane (Intermediate) Latvia
2-Thiophene Ethanol Intermediate China
4-methoxy 2,3,6-trimethyl Benzaldehyde (Intermediate) China
6-Methyluracil India
Acid Acetilsalicilic China
Albendazole India
Ambrisentan India
Ambrisentan (Intermediate) India
Ambroxol Hydrochloride India
Amlodipine India
Amlodipine Besylate India
Amoxicillin Trihydrate India
Anastrozole India
Anlotinib Hydrochloride (Capsules) India
Apremilast India
Aprepitant India
Aripiprazole India
Ascorbic Acid India
Atorvastatin Calcium India
Atorvastatin Calcium (Intermediate) India
Atorvastatin Calcium Trihydrate India
Azithromycin India
Beclomethasone Dipropionate India
Benzocaine China
Beta Lactam Side Chain (Intermediate) China
Betahistine Hydrochloride India
Betamethasone Dipropionate India
Betamethasone Sodium Phosphate India
Betamethasone Valerate India
Bicalutamide India
Bifonazole India
Bromhexine Hydrochloride India
Budesonide India
Canagliflozin India
Captopril China
Cefazolin Sodium Sterile Italy
Cefazolin Sodium Sterile China
Cefepime China
Cefepime Dihydrochloride Monohydrate sterile China
Cefepime Hydrochloride and L-Arginine China
Cefoperazone Sodium China
Cefotaxime Sodium Sterile China
Ceftazidime Pentahydrate China
Ceftazidime Pentahydrate with Sodium carbonate China
Ceftriaxone (Intermediate) China
Ceftriaxone Sodium Sterile China
Cefuroxime Sodium Sterile China
Cefuroxime Sodium Sterile India
Cefuroxime Sodium Sterile Italy
Celecoxib Capsules India
Cetirizine Dihydrochloride India
Chloramphenicol Palmitate India
Chlorpheniramine Maleate India
Choline Theophylinate India
Cilastatin Sodium India
Cinacalcet (Intermediate) India
Cinacalcet Hydrochloride India
Ciprofloxacin Hydrochloride India
Cisatracurium Besilate Spain
Citalopram Hydrobromide India
Citicoline Sodium China
Clarithromycin China
Clarithromycin India
Clobetasol Propionate India
Clopidogrel Hydrogen Sulphate India
Closantel Base India
Closantel Sodium India
Clotrimazole India
Cloxacillin India
Cytisine China
Dabigatran Etexilate Mesylate India
Deferasirox India
Dexchlorpheniramine Maleate India
Dexketoprofen Trometamol India
Diclofenac Sodium India
Dimethicone India
Donepezil India
Donepezil Hydrochloride India
Donepezil Hydrochloride (Intermediate) India
Doxorubicin Hydrochloride India
Dronedarone Hydrochloride India
Dronedarone Hydrochloride (Intermediate) India
Dronedarone Hydrochloride (Intermediate) China
Drotaverine Hydrochloride China
Drotaverine Hydrochloride India
Duloxetine Hydrochloride India
Econazole Nitrate India
Epirubicin Hydrochloride India
Eplerenone China
Eplerenone (Intermediate) China
Erythromycin Oxime (Intermediate) India
Exemestane Taiwan
Ezetimibe India
Fampridine India
Febuxostat India
Fesoterodine India
Fexofenadine Hydrochloride India
Finasteride India
Flecainide Acetate India
Fluconazole India
Fluticasone Propionate India
FMOC-Homo-ARG-PBF-OH (KSM) China
Folic Acid India
Formoterol Fumarate Dihydrate India
Fulvestrant China
Furosemide India
Gabapentin India
Gentamicin Sulfate China
Gliclazide China
Glucosamine Hydrochloride India
Glybenclamide India
Griseofulvin China
Heparin China
Hydrochlorothiazide China
Hydrochlorothiazide India
Hydrocortisone China
Hydrocortisone Acetate China
Hydroxizine Tablets India
Hyoscine Butyl Bromide India
Ibuprofen India
Imipenem Cilastatin Sterile Italy
Imipenem Monohydrate India
Imipenem Monohydrate & Cilastatin Sodium India
Irbesartan India
Isoniazid India
Isotretinoin China
Ivabradine India
Ivabradine Intermediate India
Ivabradine Intermediate China
Ketotifen Hydrofumarate China
Lacosamide India
Lacosamide (Intermediate) India
Lactose Germany
Lamotrigine India
Letrozole India
Levetiracetam India
Levocetirizine Dihydrochloride India
Lincomicin Hydrochloride China
Lisinopril Dihydrate China
Loratadine India
MAEM (Intermediate) China
Magnesium Pidolate India
Meloxicam India
Memantine Hydrochloride India
Memantine Hydrochloride (Intermediate) India
Meropenem Trihydrate India
Meropenem Trihydrate & Sodium Carbonate India
Meropenem Trihydrate Sterile Italy
Metamizole Sodium China
Metformin Hydrochloride India
Metformin Hydrochloride DC India
Metoclopramide Hydrochloride India
Miconazole Nitrate India
Mirabegron India
Modafinil India
Mometasone Furoate India
Montelukast Sodium India
Moxifloxacin Hydrochloride India
Moxifloxacin Hydrochloride Monohydrate India
Mycophenolate Mofetil India
Naproxen Base India
Naproxen Sodium India
Naproxen Sodium China
Nicotinic Acid India
Nimesulide India
Olanzapine India
Olanzapine (Intermediate) India
Olmesartan Medoxomil India
Omeprazole China
Ondansetron Hydrochloride Dihydrate India
Oxcarbazepine India
Oxyclozanide India
Paclitaxel Side Chain (Intermediate) China
Paracetamol China
Paracetamol DC 90 Granules China
Paricalcitol India
Pemetrexed Disodium Hemipentahydrate China
Perindopril India
Phenylephrine Hydrochloride Taiwan
Phenylephrine Hydrochloride India
Phthalimido Amlodipine (Intermediate) India
Pio Imino Compound (Intermediate) China
Pioglitazone Hydrochloride India
Piracetam China
Posaconazole India
Posaconazole Amorphous India
Posaconazole KSM India
Praziquantel India
Pregabalin India
Pregabalin China
Pregabalin (Intermediate) India
Pregabalin (Intermediate) China
Pyrazinamide India
Quetine Fumarate India
Rafoxanide India
Ramipril China
Ranitidine Hydrochloride India
Rasagiline India
Riboflavin 5 - Phosphate sodium India
Rifampicin China
Riluzole Taiwan
Risperidone India
Rivastigmine Hydrogen Tartrate India
Ropinirole Hydrochloride India
Rosuvastatin Calcium India
Salmeterol Xinafoate India
Scopolamine Hydrobromide India
Sildenafil Citrate India
Sildenafil Citrate (Intermediate) India
Simvastatin India
Sitagliptin Hydrochloride India
Sitagliptin Hydrochloride (Intermediate) China
Sodium Alendronate Trihydrate India
Solifenacin Succinate India
Solifenacin Succinate (Intermediate) India
Stoppers (Packing Material) France
Succinylcholine Chloride India
Sugammadex (Injection) China
Sulbactam China
Sulbactam Sodium China
Sulfadimidine China
Tadalafil India
TAEM (Intermediate) China
Telmisartan India
Temozolomide India
Terbinafine Hydrochloride India
Ticagrelor India
Ticagrelor (Intermediate) India
Tiotropium Bromide Monohydrate India
Tramadol Hydrochloride India
Tranexamic Acid China
Type-I Clear Glass Vials France
Valganciclovir (KSM) India
Valsartan India
Valsartan (Intermediate) China
Valsartan (Intermediate) India
Vildagliptin India
Vildagliptin (Intermediate) India
Vildagliptin (Intermediate) China
Vinorelbine Tartrate China
Voriconazole India

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Enquiry

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我们的机构

PharmSol GmbH

Bad Oldesloe, Germany

PharmSol Europe Limited

Mosta, Malta

Pharmaceutical Solutions FZCO

Jebel Ali, Dubai, United Arab Emirates

Pharmaceutical Solutions DMCC

Jumeirah Lake Towers, Dubai

PharmSol Egypt

Heliopolis, Cairo, Egypt

PharmSol India Pvt. Ltd.

Hyderabad, India

法索(南京)医药科技有限公司

中国 江苏省 南京市

PharmSol APAC Limited

中国 香港

PharmSol-Pharmaceutical Products Trading

Makati City, Philippines​

PharmSol Europe Limited (Rep. Office)

Ho Chi Minh City, Vietnam

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