FUZKK SEGMENTS

Manufacturing and QC segments

One company may belong to several segments.

API / CDMO / synthesis

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

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Baseline manufacturing scope

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

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Biologics

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

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Cell and gene therapy

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

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Consumer health / OTC

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

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Diagnostics and analytical systems

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

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Diversified pharma

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

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Finished dosage forms and small molecules

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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

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Oncology / ADC / high-potency

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

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Ophthalmics

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

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Peptides and complex injectables

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

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Radiopharmaceuticals

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

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Sterile and injectable products

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

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Traditional and herbal medicines

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

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Vaccines and biological products

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

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Veterinary pharma

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

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