XHIGH ULTRA CHINA TOP 1000

业务分组

一家企业可以属于多个业务分组。

OTC与大健康

16

China: national essential medicines QC package Global API & Biosimilars QC Suite

Assay & Impurity HPLC Quality Checker Dissolution Apparatus 1 & 2 Quality Checker Content Uniformity Quality Checker Microbial Enumeration (TAMC/TYMC) Quality Checker Specified Microorganisms Quality Checker Stability Condition Monitoring Quality Checker Packaging Integrity Checker Supplier Evaluation Checker

中药与植物药

62

Herbal / TCM / Ayurveda Instrumental QC Suite British Herbal Pharmacopoeia QC Suite China: national essential medicines QC package

Chromatographic Fingerprint Similarity Checker Herbal Chromatographic Fingerprint Analyzer Herbal Multi Component Assay Checker TCMDecoction Consistency Checker Herbal Pesticide Residue Checker Herbal Mycotoxin Limit Checker Herbal Heavy Metals Screening Checker Herbal Extract Solvent Residue Checker

体外诊断

5

Medical Devices Standards & Lifecycle QC Suite Medical Device Software Suite Medical Device Risk Management Suite

Companion Diagnostic Report Checker Requirement Traceability Checker Software Safety Class Checker Integration Test Coverage Checker Data Integrity Security Checker Cybersecurity Risk Assessment Checker Electrical Safety Test Summary Checker EMCTest Coverage Checker

兽药

1

Vet — Veterinary QC Utilities Global API & Biosimilars QC Suite

Herd Flock Vaccine Batch Review Utility Autogenous Vaccine Batch Traceability Utility Antibiotic Potency Assay Checker Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Microbial Enumeration (TAMC/TYMC) Quality Checker

制药装备与工程

1

Medical Devices Standards & Lifecycle QC Suite Medical Device Software Suite Medical Device QMS Suite

Design Control Compliance Checker Supplier Evaluation Checker Calibration Schedule Checker Calibration Status Checker Process Validation Checker Requirement Traceability Checker Configuration Baseline Checker Integration Test Coverage Checker

化学药与制剂

776

China: national essential medicines QC package Global API & Biosimilars QC Suite Lumex QC Suite LabEx QC Suite

Assay & Impurities Result Reviewer Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Water Content KF Quality Checker Elemental Impurities ICP Quality Checker Content Uniformity Quality Checker Dissolution Apparatus 1 & 2 Quality Checker Stability Condition Monitoring Quality Checker

医疗器械

10

Medical Devices Standards & Lifecycle QC Suite Medical Device Risk Management Suite Medical Device Software Suite Electrical Safety & EMC Suite UDI & Labeling Suite

Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Software Safety Class Checker Data Integrity Security Checker Cybersecurity Risk Assessment Checker Electrical Safety Test Summary Checker

原料药、中间体与CDMO

17

Global API & Biosimilars QC Suite World API Extension QC Suite Fermentation & Antibiotic Intermediates QC Suite Lumex QC Suite

Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Water Content KF Quality Checker Elemental Impurities ICP Quality Checker LC-MS Confirmation Quality Checker Method Validation Data Packager Process Validation Checker Change Control Impact Checker

吸入制剂

5

Inhaled Products QC Suite Medical Devices Standards & Lifecycle QC Suite

Delivered Dose Uniformity Inhaler Quality Checker Inhalation APSD Quality Checker Inhaler APSD NGI Profiler Inhaler DDU Uniformity Analyzer Inhaler Leak Test Checker Inhaler Device Lifecycle Tracker Inhaler Stability Performance Checker Requirement Traceability Checker

基础制药质量控制

50

China: national essential medicines QC package Lumex QC Suite LabEx QC Suite Medical Device QMS Suite

Assay & Impurities Result Reviewer Release Readiness Checker Genotoxic Impurity Screener M7 Content Uniformity Acceptance Value Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Water Content KF Quality Checker System Suitability Parameters Checker

多肽与胰岛素

6

Peptides, GLP-1 and Obesity QC Suite

CE Peptide Map Validator CE Peptide Map Fingerprint LC-MS Confirmation Quality Checker Insulin Analog Impurity Checker InsulinHumanHPLCChecker Human Insulin Quality Checker GLP1 Injectable Release Checker Bacterial Endotoxins LAL Quality Checker

抗生素与发酵产品

9

Fermentation & Antibiotic Intermediates QC Suite Global API & Biosimilars QC Suite

Antibiotic Intermediate Release Checker Antibiotic Potency Assay Checker Fermentation Impurity Profile Analyzer Fermentation Residual Solvent Checker Fermentation Bioburden Trend Checker Fermentation Yield Consistency Checker Six APAImpurity Profile Checker Seven ACAImpurity Profile Checker

抗疟药

1

Global API & Biosimilars QC Suite Herbal / TCM / Ayurveda Instrumental QC Suite

Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Water Content KF Quality Checker Herbal Heavy Metals Screening Checker Herbal Pesticide Residue Checker Stability Condition Monitoring Quality Checker

放射性药品

1

RPH: combined radiopharmaceutical QC package Radioligand & Theranostics Expansion QC Suite

Radionuclidic Purity Checker Bacterial Endotoxins LAL Quality Checker Sterility Test Membrane Filtration Quality Checker Particle Count Injection USP <788> Quality Checker Cold Chain Shipping Temperature And MKT Quality Checker

无菌制剂

19

LabEx QC Suite Sterile Medical Devices Suite China: national essential medicines QC package

Sterility Test Membrane Filtration Quality Checker Bacterial Endotoxins LAL Quality Checker Particle Count Injection USP <788> Quality Checker Filter Integrity Test Quality Checker Package Integrity & Leak Test Quality Checker Water For Injections Quality Checker Osmolality Quality Checker Fill Volume & Container Closure Checker

激素与高活性原料药

3

Global API & Biosimilars QC Suite Endocrinology QC Suite

Chiral Purity HPLC Quality Checker Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Water Content KF Quality Checker Elemental Impurities ICP Quality Checker Content Uniformity Quality Checker Change Control Impact Checker Process Validation Checker

生物制品

122

Global API & Biosimilars QC Suite LabEx QC Suite

Biologic Aggregate Size Quality Checker Charge Variant CE Quality Checker CE Glycosylation Profiler Protein Concentration UV Quality Checker ELISA Bioassay Quality Checker SPR Binding Affinity Quality Checker Residual Host Cell DNA Quality Checker Residual Host Protein Checker

疫苗与血液制品

8

Huvac — Human Vaccine QC Utilities Plasma-Derived Products QC Suite LabEx QC Suite

Vaccine Potency Assessor Adjuvant Aluminum Assay Checker Adjuvant Adsorption Efficiency Quality Checker Inactivated Vaccine Safety Test Quality Checker Live Attenuated Vaccine Genetic Stability Quality Checker Plasma Pool Traceability Checker Plasma Viral Clearance Evidence Checker Cold Chain Shipping Temperature And MKT Quality Checker

眼科制剂

3

Ophthalmic & Intravitreal QC Suite LabEx QC Suite

Ophthalmic Solution Quality Checker Ophthalmic Osmolality PHChecker Ophthalmic Particulate Matter Checker Ophthalmic Container Closure Integrity Checker Ophthalmic Extractables Leachables Checker Ophthalmic Sterility Endotoxin Ultra Checker

细胞与基因技术

2

Cell & Gene Therapy / Viral Vector QC Suite

Vector Genome Titer q PCR Analyzer Replication Competent Virus RCV Quality Checker Residual Host Cell DNA Quality Checker Residual Host Protein Checker Sterility Test Membrane Filtration Quality Checker Bacterial Endotoxins LAL Quality Checker

经皮给药系统

1

Global API & Biosimilars QC Suite Medical Devices Standards & Lifecycle QC Suite

Assay & Impurity HPLC Quality Checker Content Uniformity Quality Checker Residual Solvents GC Quality Checker Stability Condition Monitoring Quality Checker Packaging Integrity Checker Supplier Evaluation Checker

维生素与营养成分

4

Global API & Biosimilars QC Suite

Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Water Content KF Quality Checker Elemental Impurities ICP Quality Checker UV-Vis Identity & Assay Quality Checker AAS Microelements Supplements Stability Condition Monitoring Quality Checker

肝素与血浆制品

3

Plasma-Derived Products QC Suite

Heparin Sodium Quality Checker HeparinSodiumMolecularWeightChecker Plasma Pool Traceability Checker Plasma Viral Clearance Evidence Checker Residual Solvent Detergent Checker Bacterial Endotoxins LAL Quality Checker Sterility Test Membrane Filtration Quality Checker

肿瘤药、ADC与高活性产品

11

ADC / Conjugated Biologics QC Suite Global API & Biosimilars QC Suite

ADC Aggregation Monitor ADC Drug Antibody Ratio Analyzer ADC Free Payload Quantifier ADC Linker Stability Profiler ADCRelease Readiness Checker Assay & Impurity HPLC Quality Checker LC-MS Confirmation Quality Checker Sterility Test Membrane Filtration Quality Checker

跨国药企在华业务

15

Global API & Biosimilars QC Suite Medical Device QMS Suite Medical Device Software Suite

Change Control Impact Checker Process Validation Checker Method Validation Data Packager Data Integrity Security Checker Requirement Traceability Checker Supplier Evaluation Checker Production Record Consistency Checker Release Readiness Checker