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Article: Global API & Biosimilars QC Suite

Package for high-demand global APIs, generics and biosimilars, including fixed-dose combinations and biological products.

Package
Global API & Biosimilars
Category
Global API
Utilities
83
Format
CSV → JSON

Why choose FUZKK Utilities?

✅ Replace Excel

No hidden formulas or accidental edits. Deterministic logic, version control and reproducible results.

🔍 Audit-ready (IQ/OQ)

Each utility is supplied with URS & FS templates. This accelerates validation preparation and inspections.

⏱ Save QC time

Automate checks, calculations and reporting. The team focuses on deviations and scientific assessment rather than formatting.

🚀 Fast deployment

CSV input and JSON output allow integration without building heavy custom LIMS modules from scratch.

Integration workflow

LIMS / ELN / CSV export -> FUZKK utility -> output.json -> QMS / eDMS / batch release

The utilities read CSV input and generate structured JSON output suitable for automated batch release, QA/QC review and LIMS/ELN/MES integration.

Utilities in this package

#API / productUtilityKey checks
1Aceclofenac ParacetamolAceclofenacParacetamolQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
2AdalimumabAdalimumabQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
3AfliberceptAfliberceptQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
4AmoxicillinAmoxicillinQualityCheckerantibiotics, API, assay, biosimilars, fixed-dose combinations
5Amoxicillin Clavulanic AcidAmoxicillinClavulanicAcidQualityCheckerantibiotics, API, assay, biosimilars, dissolution
6ApixabanApixabanQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
7AspirinAspirinQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
8Atorvastatin AspirinAtorvastatinAspirinQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
9BevacizumabBevacizumabQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
10BudesonideBudesonideQualityCheckerAPI, assay, biosimilars, fixed-dose combinations, generics
11Budesonide FormoterolBudesonideFormoterolQualityCheckerAPI, assay, biosimilars, fixed-dose combinations, generics
12BupropionBupropionQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
13CarvedilolCarvedilolQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
14CeftriaxoneCeftriaxoneQualityCheckerantibiotics, API, assay, biosimilars, endotoxins
15CilnidipineCilnidipineQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
16CyclobenzaprineCyclobenzaprineQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
17DapagliflozinDapagliflozinQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
18Dapagliflozin MetforminDapagliflozinMetforminQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
19DenosumabDenosumabQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
20DrotaverineDrotaverineQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
21EmpagliflozinEmpagliflozinQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
22EntecavirEntecavirQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
23Epoetin AlfaEpoetinAlfaQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
24Epoetin BetaEpoetinBetaQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
25EtanerceptEtanerceptQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
26EzetimibeEzetimibeQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
27FexofenadineFexofenadineQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
28FilgrastimFilgrastimQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
29Fluticasone Propionate NasalFluticasonePropionateNasalQualityCheckerAPI, assay, biologics, biosimilars, fixed-dose combinations
30Fluticasone SalmeterolFluticasoneSalmeterolQualityCheckerAPI, assay, biosimilars, capsules, fixed-dose combinations
31Gabapentin MethylcobalaminGabapentinMethylcobalaminQualityCheckerAPI, assay, biologics, biosimilars, dissolution
32GliclazideGliclazideQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
33Glimepiride MetforminGlimepirideMetforminQualityCheckerAPI, assay, biologics, biosimilars, dissolution
34Human InsulinHumanInsulinQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
35Hydrocodone AcetaminophenHydrocodoneAcetaminophenQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
36Ibuprofen ParacetamolIbuprofenParacetamolQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
37Insulin AspartInsulinAspartQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
38Insulin GlargineInsulinGlargineQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
39Insulin Human PremixInsulinHumanPremixQualityCheckerantivirals, API, assay, biologics, biosimilars
40Insulin LisproInsulinLisproQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
41Iron SaltsIronSaltsQualityCheckerAPI, assay, biosimilars, fixed-dose combinations, generics
42IvermectinIvermectinQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
43LactuloseLactuloseQualityCheckerAPI, assay, biologics, biosimilars, fixed-dose combinations
44LenalidomideLenalidomideQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
45LetrozoleLetrozoleQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
46LevocetirizineLevocetirizineQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
47Levothyroxine SodiumLevothyroxineSodiumQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
48MethylphenidateMethylphenidateQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
49Mixed Amphetamine SaltsMixedAmphetamineSaltsQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
50MontelukastMontelukastQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
51Montelukast LevocetirizineMontelukastLevocetirizineQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
52MoxifloxacinMoxifloxacinQualityCheckerantibiotics, API, assay, biosimilars, dissolution
53Mycophenolate MofetilMycophenolateMofetilQualityCheckerAPI, assay, biologics, biosimilars, dissolution
54NitrofurantoinNitrofurantoinQualityCheckerantibiotics, API, assay, biosimilars, dissolution
55Ofloxacin OrnidazoleOfloxacinOrnidazoleQualityCheckerantibiotics, API, assay, biosimilars, dissolution
56OlmesartanOlmesartanQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
57OseltamivirOseltamivirQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
58PancreatinPancreatinQualityCheckerAPI, assay, biologics, biosimilars, fixed-dose combinations
59Pantoprazole DomperidonePantoprazoleDomperidoneQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
60PegfilgrastimPegfilgrastimQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
61PemetrexedPemetrexedQualityCheckerAPI, assay, biosimilars, endotoxins, fixed-dose combinations
62PioglitazonePioglitazoneQualityCheckerAPI, assay, biologics, biosimilars, dissolution
63Piperacillin TazobactamPiperacillinTazobactamQualityCheckerantibiotics, API, assay, biosimilars, endotoxins
64PravastatinPravastatinQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
65PrednisonePrednisoneQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
66Pregabalin MethylcobalaminPregabalinMethylcobalaminQualityCheckerAPI, assay, biologics, biosimilars, dissolution
67RanibizumabRanibizumabQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
68RituximabRituximabQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
69SalbutamolSalbutamolQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
70Sitagliptin MetforminSitagliptinMetforminQualityCheckerAPI, assay, biologics, biosimilars, dissolution
71TacrolimusTacrolimusQualityCheckerAPI, assay, biosimilars, capsules, dissolution
72TelmisartanTelmisartanQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
73Telmisartan AmlodipineTelmisartanAmlodipineQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
74Tenofovir Disoproxil FumarateTenofovirDisoproxilFumarateQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
75TeriparatideTeriparatideQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
76TorasemideTorasemideQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
77TrastuzumabTrastuzumabQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
78Ursodeoxycholic AcidUrsodeoxycholicAcidQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
79UstekinumabUstekinumabQualityCheckerAPI, assay, biologics, biosimilars, endotoxins
80Valproic AcidValproicAcidQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
81VildagliptinVildagliptinQualityCheckerAPI, assay, biosimilars, dissolution, fixed-dose combinations
82Vildagliptin MetforminVildagliptinMetforminQualityCheckerAPI, assay, biologics, biosimilars, dissolution
83XylometazolineXylometazolineQualityCheckerAPI, assay, biologics, biosimilars, fixed-dose combinations

Package positioning

The package is a marketing and technical selection. It is suitable for the first discussion with QC, portfolio coverage assessment, pilot scoping and integration planning.
API generics biosimilars fixed-dose combinations market map assay

Licensing & support

  • License is granted to one pharmaceutical company or manufacturing site, with no redistribution rights.
  • Utilities are provided “as is”; validation is performed by the client using URS & FS / IQ/OQ templates.
  • Integration support is available for LIMS/ELN/MES, pilot preparation and CSV/JSON workflow clarification.
  • No public price is shown: the commercial proposal depends on package scope, number of sites, delivery model and support level.
Questions? Need a QC demo or pilot?👉 Representative — FUZKK Pharma Utilities

Open package in the portal

© 2026 FUZKK Pharma · For QC/GMP implementation discussion

Utilities and checked parameters

#API / productUtilityKey checks
1Aceclofenac Paracetamolaceclofenac paracetamolAceclofenac Paracetamol Quality Checker — Combined Analgesic (Ph.
2AdalimumabadalimumabAdalimumab Quality Checker — Biologic Drug (Monoclonal Antibody) (Ph.
3AfliberceptafliberceptAflibercept Quality Checker — Biologic Drug (Recombinant Fusion Protein) (Ph.
4AmoxicillinamoxicillinAmoxicillin Quality Checker — Antibiotic (Penicillin) (Ph.
5Amoxicillin Clavulanic Acidamoxicillin clavulanic acidAmoxicillin Clavulanic Acid Quality Checker — Combined Antibiotic (Ph.
6ApixabanapixabanApixaban Quality Checker — Anticoagulant (Factor Xa Inhibitor) (Ph.
7AspirinaspirinAspirin Quality Checker — Acetylsalicylic Acid (Ph.
8Atorvastatin Aspirinatorvastatin aspirinAtorvastatin Aspirin Quality Checker — Combo Product (Statin + NSAID) (Ph.
9BevacizumabbevacizumabBevacizumab Quality Checker — Biologic Drug (Monoclonal Antibody) (Ph.
10BudesonidebudesonideBudesonide Quality Checker — Glucocorticosteroid (Ph.
11Budesonide Formoterolbudesonide formoterolBudesonide Formoterol Quality Checker — Inhalation Product (Ph.
12BupropionbupropionBupropion Quality Checker — Antidepressant (Ph. Eur., USP) ℹ️ The utility checks assay, specific rotation, impurities, dissolution profile (for SR/XL), residual solvents. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL…
13CarvedilolcarvedilolCarvedilol Quality Checker — Beta-Blocker (Ph. Eur., USP) ℹ️ The utility checks assay, specific rotation (S-enantiomer), impurities, dissolution profile, toluene. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
14CeftriaxoneceftriaxoneCeftriaxone Quality Checker — 3rd Generation Cephalosporin (Ph.
15CilnidipinecilnidipineCilnidipine Quality Checker — Calcium Channel Blocker (Ph.
16CyclobenzaprinecyclobenzaprineCyclobenzaprine Quality Checker — Muscle Relaxant (Ph.
17DapagliflozindapagliflozinDapagliflozin Quality Checker — SGLT2 Inhibitor (Ph.
18Dapagliflozin Metformindapagliflozin metforminDapagliflozin Metformin Quality Checker — Combo Product (SGLT2 + Biguanide) ℹ️ The utility checks content of both APIs, specific metformin impurities, synchronous dissolution.
19DenosumabdenosumabDenosumab Quality Checker — Biologic Drug (Monoclonal Antibody) (Ph.
20DrotaverinedrotaverineDrotaverine Quality Checker — Myotropic Antispasmodic (Ph.
21EmpagliflozinempagliflozinEmpagliflozin Quality Checker — SGLT2 Inhibitor (Ph.
22EntecavirentecavirEntecavir Quality Checker — Antiviral (Nucleoside Analog) (Ph.
23Epoetin Alfaepoetin alfaEpoetin Alfa Quality Checker — Biologic Drug (Erythropoietin) (Ph.
24Epoetin Betaepoetin betaEpoetin Beta Quality Checker — Biologic Drug (Erythropoietin Beta) (Ph.
25EtanerceptetanerceptEtanercept Quality Checker — Biologic Drug (TNF-Receptor Fusion Protein) (Ph.
26EzetimibeezetimibeEzetimibe Quality Checker — Lipid-Lowering Agent (Ph.
27FexofenadinefexofenadineFexofenadine Quality Checker — Antihistamine (Ph. Eur., USP) ℹ️ The utility checks assay, melting point, impurities (especially terfenadine), dissolution profile, methanol. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITIC…
28FilgrastimfilgrastimFilgrastim Quality Checker — Biologic Drug (G-CSF) (Ph.
29Fluticasone Propionate Nasalfluticasone propionate nasalFluticasone Propionate Nasal Quality Checker — Nasal Spray (Ph.
30Fluticasone Salmeterolfluticasone salmeterolFluticasone Salmeterol Quality Checker — Combo Inhaler (ICS + LABA) (Ph.
31Gabapentin Methylcobalamingabapentin methylcobalaminGabapentin Methylcobalamin Quality Checker — Combo Product (Neurotropic) ℹ️ The utility checks content of both APIs, B12 degradation, content uniformity, dissolution.
32GliclazidegliclazideGliclazide Quality Checker — Sulfonylurea Antidiabetic (Ph.
33Glimepiride Metforminglimepiride metforminGlimepiride Metformin Quality Checker — Combo Product (Sulfonylurea + Biguanide) ℹ️ The utility checks content of both APIs, content uniformity (low dose glimepiride), metformin impurities, dissolution.
34Human Insulinhuman insulinHuman Insulin Quality Checker — Biologic Drug (Peptide Hormone) (Ph.
35Hydrocodone Acetaminophenhydrocodone acetaminophenHydrocodone Acetaminophen Quality Checker — Combo Analgesic (USP) ℹ️ The utility checks content of both APIs, PAP (toxicity), thebaine, uniformity, dissolution.
36Ibuprofen Paracetamolibuprofen paracetamolIbuprofen Paracetamol Quality Checker — Combo Analgesic (USP/Ph.
37Insulin Aspartinsulin aspartInsulin Aspart Quality Checker — Biologic Drug (Insulin Analog) (Ph.
38Insulin Glargineinsulin glargineInsulin Glargine Quality Checker — Biologic Drug (Long-acting Insulin Analog) (Ph.
39Insulin Human Premixinsulin human premixInsulin Human Premix Quality Checker — Biologic Drug (NPH+Soluble Mix) (Ph.
40Insulin Lisproinsulin lisproInsulin Lispro Quality Checker — Biologic Drug (Rapid-acting Insulin Analog) (Ph.
41Iron Saltsiron saltsIron Salts Quality Checker — Iron Preparations (Ph.
42IvermectinivermectinIvermectin Quality Checker — Antiparasitic Agent (Ph.
43LactuloselactuloseLactulose Quality Checker — Osmotic Laxative (Ph. Eur., USP) ℹ️ The utility checks lactulose content, lactose, HMF, osmolality, microbiology. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
44LenalidomidelenalidomideLenalidomide Quality Checker — Immunomodulator (Ph.
45LetrozoleletrozoleLetrozole Quality Checker — Aromatase Inhibitor (Ph.
46LevocetirizinelevocetirizineLevocetirizine Quality Checker — Antihistamine (Ph.
47Levothyroxine Sodiumlevothyroxine sodiumLevothyroxine Sodium Quality Checker — Thyroid Hormone (Ph.
48MethylphenidatemethylphenidateMethylphenidate Quality Checker — Psychostimulant (Ph.
49Mixed Amphetamine Saltsmixed amphetamine saltsMixed Amphetamine Salts Quality Checker — Psychostimulant (USP) ℹ️ The utility checks assay, D/L ratio (3:1), phenylacetone, dissolution profile.
50MontelukastmontelukastMontelukast Quality Checker — Leukotriene Receptor Antagonist (Ph.
51Montelukast Levocetirizinemontelukast levocetirizineMontelukast Levocetirizine Quality Checker — Combo Product (Asthma/Allergy) ℹ️ The utility checks content of both APIs, montelukast sulfoxide, dextrocetirizine, moisture, uniformity.
52MoxifloxacinmoxifloxacinMoxifloxacin Quality Checker — Fluoroquinolone Antibiotic (Ph.
53Mycophenolate Mofetilmycophenolate mofetilMycophenolate Mofetil Quality Checker — Immunosuppressant (Ph.
54NitrofurantoinnitrofurantoinNitrofurantoin Quality Checker — Antibacterial Agent (Ph.
55Ofloxacin Ornidazoleofloxacin ornidazoleOfloxacin Ornidazole Quality Checker — Combo Antibiotic/Antiprotozoal ℹ️ The utility checks content of both APIs, nitro-impurities, synchronous dissolution.
56OlmesartanolmesartanOlmesartan Quality Checker — Angiotensin II Receptor Antagonist (Ph.
57OseltamiviroseltamivirOseltamivir Quality Checker — Antiviral Agent (Ph. Eur., USP) ℹ️ The utility checks assay, hydrolysis products, toluene, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
58PancreatinpancreatinPancreatin Quality Checker — Enzyme Preparation (Ph.
59Pantoprazole Domperidonepantoprazole domperidonePantoprazole Domperidone Quality Checker — Combo Product (GI Tract) ℹ️ The utility checks content of both APIs, pantoprazole degradation, moisture, uniformity.
60PegfilgrastimpegfilgrastimPegfilgrastim Quality Checker — Biologic Drug (Pegylated G-CSF) (Ph.
61PemetrexedpemetrexedPemetrexed Quality Checker — Antineoplastic Agent (Ph.
62PioglitazonepioglitazonePioglitazone Quality Checker — Insulin Sensitizer (Ph.
63Piperacillin Tazobactampiperacillin tazobactamPiperacillin Tazobactam Quality Checker — Combo Antibiotic (Injections) (Ph.
64PravastatinpravastatinPravastatin Quality Checker — Statin (Ph. Eur., USP) ℹ️ The utility checks assay, specific rotation, lactone form (impurity), dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
65PrednisoneprednisonePrednisone Quality Checker — Glucocorticoid (Ph. Eur., USP) ℹ️ The utility checks assay, specific rotation, DCM, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
66Pregabalin Methylcobalaminpregabalin methylcobalaminPregabalin Methylcobalamin Quality Checker — Combo Product (Neurotropic) ℹ️ The utility checks content of both APIs, Pregabalin R-enantiomer, B12 degradation, content uniformity.
67RanibizumabranibizumabRanibizumab Quality Checker — Biologic Drug (Anti-VEGF Fab fragment) (Ph.
68RituximabrituximabRituximab Quality Checker — Biologic Drug (Anti-CD20 mAb) (Ph.
69SalbutamolsalbutamolSalbutamol Quality Checker — Bronchodilator (Ph. Eur., USP) ℹ️ The utility checks assay, specific rotation, salbutamol ketone, toluene, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
70Sitagliptin Metforminsitagliptin metforminSitagliptin Metformin Quality Checker — Combo Product (Diabetes) ℹ️ The utility checks content of both APIs, NDMA (nitrosamines) in metformin, sitagliptin uniformity.
71TacrolimustacrolimusTacrolimus Quality Checker — Immunosuppressant (Ph.
72TelmisartantelmisartanTelmisartan Quality Checker — Angiotensin II Receptor Antagonist (Ph.
73Telmisartan Amlodipinetelmisartan amlodipineTelmisartan Amlodipine Quality Checker — Combo Product (Hypertension) ℹ️ The utility checks content of both APIs, telmisartan solubility, amlodipine uniformity.
74Tenofovir Disoproxil Fumaratetenofovir disoproxil fumarateTenofovir Disoproxil Fumarate Quality Checker — Antiretroviral Agent (Ph.
75TeriparatideteriparatideTeriparatide Quality Checker — Biologic Drug (Parathyroid Hormone) (Ph.
76TorasemidetorasemideTorasemide Quality Checker — Loop Diuretic (Ph. Eur., USP) ℹ️ The utility checks assay, impurities, toluene, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
77TrastuzumabtrastuzumabTrastuzumab Quality Checker — Biologic Drug (Anti-HER2 mAb) (Ph.
78Ursodeoxycholic Acidursodeoxycholic acidUrsodeoxycholic Acid Quality Checker — Bile Acid (Ph.
79UstekinumabustekinumabUstekinumab Quality Checker — Biologic Drug (Anti-IL-12/23 mAb) (Ph.
80Valproic Acidvalproic acidValproic Acid Quality Checker — Anticonvulsant (Ph.
81VildagliptinvildagliptinVildagliptin Quality Checker — DPP-4 Inhibitor (Ph.
82Vildagliptin Metforminvildagliptin metforminVildagliptin Metformin Quality Checker — Combo Product (Diabetes) ℹ️ The utility checks content of both APIs, NDMA (nitrosamines) in metformin, cyanide in vildagliptin.
83XylometazolinexylometazolineXylometazoline Quality Checker — Nasal Decongestant (Ph.