Пакет
Global API & Biosimilars
Категория
Global API
Утилит
83
Формат
CSV → JSON
Почему выбирают FUZKK Utilities?
✅ Замена Excel
Никаких скрытых формул и случайных правок. Детерминированная логика, версионность и воспроизводимые результаты.
🔍 Готовность к аудиту (IQ/OQ)
Каждая утилита поставляется с шаблонами URS & FS. Это ускоряет подготовку к валидации и инспекциям.
⏱ Экономия времени ОКК
Автоматизация проверок, расчётов и отчётности. Команда фокусируется на отклонениях и научной оценке, а не на форматировании.
🚀 Быстрое внедрение
CSV-вход и JSON-выход позволяют интегрировать пакет без разработки тяжёлых LIMS-модулей с нуля.
Схема интеграции
LIMS / ELN / CSV-export → утилита FUZKK → output.json → QMS / eDMS / batch release
Утилиты читают CSV-вход и формируют структурированный JSON-результат, пригодный для автоматизированного batch release, QA/QC review и интеграции с LIMS/ELN/MES.
Утилиты в пакете
| № | API / продукт | Утилита | Ключевые проверки |
|---|---|---|---|
| 1 | Aceclofenac Paracetamol | AceclofenacParacetamolQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 2 | Adalimumab | AdalimumabQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 3 | Aflibercept | AfliberceptQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 4 | Amoxicillin | AmoxicillinQualityChecker | antibiotics, API, assay, biosimilars, fixed-dose combinations |
| 5 | Amoxicillin Clavulanic Acid | AmoxicillinClavulanicAcidQualityChecker | antibiotics, API, assay, biosimilars, dissolution |
| 6 | Apixaban | ApixabanQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 7 | Aspirin | AspirinQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 8 | Atorvastatin Aspirin | AtorvastatinAspirinQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 9 | Bevacizumab | BevacizumabQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 10 | Budesonide | BudesonideQualityChecker | API, assay, biosimilars, fixed-dose combinations, generics |
| 11 | Budesonide Formoterol | BudesonideFormoterolQualityChecker | API, assay, biosimilars, fixed-dose combinations, generics |
| 12 | Bupropion | BupropionQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 13 | Carvedilol | CarvedilolQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 14 | Ceftriaxone | CeftriaxoneQualityChecker | antibiotics, API, assay, biosimilars, endotoxins |
| 15 | Cilnidipine | CilnidipineQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 16 | Cyclobenzaprine | CyclobenzaprineQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 17 | Dapagliflozin | DapagliflozinQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 18 | Dapagliflozin Metformin | DapagliflozinMetforminQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 19 | Denosumab | DenosumabQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 20 | Drotaverine | DrotaverineQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 21 | Empagliflozin | EmpagliflozinQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 22 | Entecavir | EntecavirQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 23 | Epoetin Alfa | EpoetinAlfaQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 24 | Epoetin Beta | EpoetinBetaQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 25 | Etanercept | EtanerceptQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 26 | Ezetimibe | EzetimibeQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 27 | Fexofenadine | FexofenadineQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 28 | Filgrastim | FilgrastimQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 29 | Fluticasone Propionate Nasal | FluticasonePropionateNasalQualityChecker | API, assay, biologics, biosimilars, fixed-dose combinations |
| 30 | Fluticasone Salmeterol | FluticasoneSalmeterolQualityChecker | API, assay, biosimilars, capsules, fixed-dose combinations |
| 31 | Gabapentin Methylcobalamin | GabapentinMethylcobalaminQualityChecker | API, assay, biologics, biosimilars, dissolution |
| 32 | Gliclazide | GliclazideQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 33 | Glimepiride Metformin | GlimepirideMetforminQualityChecker | API, assay, biologics, biosimilars, dissolution |
| 34 | Human Insulin | HumanInsulinQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 35 | Hydrocodone Acetaminophen | HydrocodoneAcetaminophenQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 36 | Ibuprofen Paracetamol | IbuprofenParacetamolQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 37 | Insulin Aspart | InsulinAspartQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 38 | Insulin Glargine | InsulinGlargineQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 39 | Insulin Human Premix | InsulinHumanPremixQualityChecker | antivirals, API, assay, biologics, biosimilars |
| 40 | Insulin Lispro | InsulinLisproQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 41 | Iron Salts | IronSaltsQualityChecker | API, assay, biosimilars, fixed-dose combinations, generics |
| 42 | Ivermectin | IvermectinQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 43 | Lactulose | LactuloseQualityChecker | API, assay, biologics, biosimilars, fixed-dose combinations |
| 44 | Lenalidomide | LenalidomideQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 45 | Letrozole | LetrozoleQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 46 | Levocetirizine | LevocetirizineQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 47 | Levothyroxine Sodium | LevothyroxineSodiumQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 48 | Methylphenidate | MethylphenidateQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 49 | Mixed Amphetamine Salts | MixedAmphetamineSaltsQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 50 | Montelukast | MontelukastQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 51 | Montelukast Levocetirizine | MontelukastLevocetirizineQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 52 | Moxifloxacin | MoxifloxacinQualityChecker | antibiotics, API, assay, biosimilars, dissolution |
| 53 | Mycophenolate Mofetil | MycophenolateMofetilQualityChecker | API, assay, biologics, biosimilars, dissolution |
| 54 | Nitrofurantoin | NitrofurantoinQualityChecker | antibiotics, API, assay, biosimilars, dissolution |
| 55 | Ofloxacin Ornidazole | OfloxacinOrnidazoleQualityChecker | antibiotics, API, assay, biosimilars, dissolution |
| 56 | Olmesartan | OlmesartanQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 57 | Oseltamivir | OseltamivirQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 58 | Pancreatin | PancreatinQualityChecker | API, assay, biologics, biosimilars, fixed-dose combinations |
| 59 | Pantoprazole Domperidone | PantoprazoleDomperidoneQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 60 | Pegfilgrastim | PegfilgrastimQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 61 | Pemetrexed | PemetrexedQualityChecker | API, assay, biosimilars, endotoxins, fixed-dose combinations |
| 62 | Pioglitazone | PioglitazoneQualityChecker | API, assay, biologics, biosimilars, dissolution |
| 63 | Piperacillin Tazobactam | PiperacillinTazobactamQualityChecker | antibiotics, API, assay, biosimilars, endotoxins |
| 64 | Pravastatin | PravastatinQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 65 | Prednisone | PrednisoneQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 66 | Pregabalin Methylcobalamin | PregabalinMethylcobalaminQualityChecker | API, assay, biologics, biosimilars, dissolution |
| 67 | Ranibizumab | RanibizumabQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 68 | Rituximab | RituximabQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 69 | Salbutamol | SalbutamolQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 70 | Sitagliptin Metformin | SitagliptinMetforminQualityChecker | API, assay, biologics, biosimilars, dissolution |
| 71 | Tacrolimus | TacrolimusQualityChecker | API, assay, biosimilars, capsules, dissolution |
| 72 | Telmisartan | TelmisartanQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 73 | Telmisartan Amlodipine | TelmisartanAmlodipineQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 74 | Tenofovir Disoproxil Fumarate | TenofovirDisoproxilFumarateQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 75 | Teriparatide | TeriparatideQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 76 | Torasemide | TorasemideQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 77 | Trastuzumab | TrastuzumabQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 78 | Ursodeoxycholic Acid | UrsodeoxycholicAcidQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 79 | Ustekinumab | UstekinumabQualityChecker | API, assay, biologics, biosimilars, endotoxins |
| 80 | Valproic Acid | ValproicAcidQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 81 | Vildagliptin | VildagliptinQualityChecker | API, assay, biosimilars, dissolution, fixed-dose combinations |
| 82 | Vildagliptin Metformin | VildagliptinMetforminQualityChecker | API, assay, biologics, biosimilars, dissolution |
| 83 | Xylometazoline | XylometazolineQualityChecker | API, assay, biologics, biosimilars, fixed-dose combinations |
Позиционирование пакета
Пакет является маркетинговой и технической подборкой. Его удобно использовать для первичного разговора с ОКК/QC, оценки покрытия портфеля, пилота и подготовки интеграции.
Лицензирование и поддержка
- Лицензия предоставляется одной фармацевтической компании или производственной площадке, без права распространения.
- Утилиты предоставляются «как есть»; валидацию выполняет клиент с использованием URS & FS / IQ/OQ-шаблонов.
- Доступна интеграционная поддержка для LIMS/ELN/MES, подготовки пилота и уточнения CSV/JSON-потока.
- Публичная цена не указана: коммерческое предложение зависит от состава пакета, количества площадок, модели поставки и объёма поддержки.
Вопросы? Нужна демонстрация или пилот для ОКК?👉 Представитель — FUZKK Pharma Utilities