شركات HPAPI CDMO|
خدمات تصنيع API عالية الفعالية

شركاؤك الموثوقون لخدمات تصنيع وتطوير واجهة برمجة التطبيقات عالية الفعالية

المرشحات المطبقة:4 / HPAPI (PDE = 10 - 100 µg/day)×5 / HPAPI (PDE < 10 µg/day)×مسح الكل

عرض 71 مرافق

الترتيب حسب:

الصين

Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site

Seacross Pharmaceutical Co Ltd

موقع تصنيع التركيبات مخصص لتطوير وإنتاج أشكال جرعات معقدة وعالية القيمة.

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Markets: Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), TGA (Australia), بقية العالم

Batch Size: Large, Small, Medium

Use: Human

BSL (Biological Safety Level): 1, 2, 3, 4

Compliance: ISO, FDA (cGMP), DIGEMID, BRCGS, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, TGA (Australia GMP), TITCK (Turkish Health Authorities), INVIMA, ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), World Health Organization (GMP / HACCP), NMPA (China GMP), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, SQF (Safe Quality Food), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)

Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging

Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (B) Blood and blood forming organs, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (S) Sensory organs, (V06) Nutrients, (V01) Allergens, (R) Respiratory system, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (H) Systemic hormonal preparations excl. sex hormones and insulins, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Category / Product: FDF / DRUG PRODUCTS, SERVICES

Region: APAC

الصين

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site

Seacross Pharmaceutical Co Ltd

يلعب مركز البحث والتطوير دورًا أساسيًا في دعم تطوير كل من واجهات برمجة التطبيقات وأشكال الجرعات النهائية.

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Batch Size: Large, Small, Medium

Use: Human

BSL (Biological Safety Level): 1, 2, 3, 4

Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging

Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (S) Sensory organs, (V06) Nutrients, (V01) Allergens, (R) Respiratory system, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (H) Systemic hormonal preparations excl. sex hormones and insulins, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use

Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC

Region: APAC

اليونان

Adragos Pharma | Athens

Adragos Pharma

متخصص في تطوير أدوية القيمة المضافة وتم ترقيته مؤخرًا بقدرات HPAPI.

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Markets: Health Canada (Canada), ANVISA (Brazil), FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), CDSCO (India), EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)

Batch Size: Large, Small, Medium

Use: Human

Compliance: ISO, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), NMPA (China GMP), MHRA (UK GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, UAE Ministry of Health & Prevention

Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse, High potential for abuse & medical use

Category / Product: FDF / DRUG PRODUCTS, SERVICES

Region: Europe

الهند

HIKAL | Mumbai

Hikal Ltd.

"هيكال" هي شركة رائدة في مجال تطوير وتصنيع الأدوية متخصصة في الجزيئات الصغيرة، ومركبات HPAPI، وتطوير العمليات، والتوليف المخصص، والتصنيع التجاري.

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Markets: Health Canada (Canada), ANVISA (Brazil), FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), CDSCO (India), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), MFDS (South Korea), TGA (Australia), بقية العالم

Batch Size: Large, Small, Medium

Use: Human, Veterinary

BSL (Biological Safety Level): 1, 2, 3, 4

Compliance: ISO, ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), ECOVADIS, World Health Organization (GMP / HACCP), Health Canada (Canada GMP), MHRA (UK GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), PMDA (Japan), ANVISA (Brazil), Health Canada

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use

Category / Product: SERVICES, CHEMICAL-SYNTHETIC

Region: APAC

فرنسا

CARBOGEN AMCIS | Saint-Beauzire

CARBOGEN AMCIS

تطوير صياغة مخصصة وتصنيع GMP المعقم للمنتجات الدوائية السائلة والمجففة بالتجميد.

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Batch Size: Large, Small, Medium

Use: Human

Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), CDSCO (India), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia), بقية العالم

Services: Development services, Analytical / QC services, Regulatory services, Manufacturing services, Quality Assurance services

Compliance: ISO, FDA (cGMP), ANVISA (Brazil B-GMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), French Service-Public (CIR), ANMAT (Argentina nueva GMP), Health Canada (Canada GMP), MHRA (UK GMP), World Health Organization (GMP / HACCP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use

Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (S) Sensory organs, (R) Respiratory system, (L) Antineoplastic and immunomodulating agents, (H) Systemic hormonal preparations excl. sex hormones and insulins, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism

Category / Product: FDF / DRUG PRODUCTS

Region: Europe

سويسرا

CARBOGEN AMCIS | Vionnaz

CARBOGEN AMCIS

تطوير واجهات برمجة التطبيقات عالية الفعالية وإنتاج cGMP على نطاق صغير بما في ذلك التحليل اللوني والتجفيد.

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Services: Development services, Analytical / QC services, Quality Assurance services, Manufacturing services

Markets: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)

Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

Use: Human, Veterinary

Batch Size: Small

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Region: Europe

Category / Product: CHEMICAL-SYNTHETIC

سويسرا

CARBOGEN AMCIS | Bubendorf

CARBOGEN AMCIS

تطوير وتصنيع cGMP لـ API عالي الفعالية بما في ذلك اتحادات أدوية الأجسام المضادة (ADC).

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Services: Development services, Analytical / QC services, Regulatory services, Quality Assurance services, Manufacturing services

Markets: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)

Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

Use: Human, Veterinary

Therapeutic Areas of Expertise (ATC): (V09-10) Radiopharmaceuticals, (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism

Batch Size: Small, Medium

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Category / Product: PARTICLE ENGINEERING, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC

Region: Europe

الصين

CARBOGEN AMCIS | Shanghai, China

CARBOGEN AMCIS

التصنيع على نطاق واسع.

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Batch Size: Large, Small, Medium

Use: Human

Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging

Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (D) Dermatologicals, (J) Antiinfectives for systemic use, (B) Blood and blood forming organs, (N) Nervous system, (S) Sensory organs, (V06) Nutrients, (V01) Allergens, (R) Respiratory system, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism

Compliance: ANVISA (Brazil B-GMP), NMPA (China GMP)

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Category / Product: SERVICES, CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES

Region: APAC

هولندا

CARBOGEN AMCIS | Veenendaal

CARBOGEN AMCIS

تصنيع نظائرها من الكوليسترول وفيتامين د على نطاق واسع.

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Use: Human, Veterinary

BSL (Biological Safety Level): 1

Compliance: DIGEMID, BRCGS, ISO, FDA (cGMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, PMDA/MHLW (Japan GMP), TITCK (Turkish Health Authorities), INVIMA, ECOVADIS, TGA (Australia GMP), ISP (Chile BPM), French Service-Public (CIR), ANMAT (Argentina nueva GMP), NMPA (China GMP), Health Canada (Canada GMP), MHRA (UK GMP), World Health Organization (GMP / HACCP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, SQF (Safe Quality Food), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)

Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia), بقية العالم

Services: Development services, Logistics, Analytical / QC services, Regulatory services, Packaging, Manufacturing services, Quality Assurance services

Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (B) Blood and blood forming organs, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (S) Sensory organs, (V09-10) Radiopharmaceuticals, (V06) Nutrients, (V01) Allergens, (R) Respiratory system, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (H) Systemic hormonal preparations excl. sex hormones and insulins, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism

Batch Size: Small

Category / Product: SERVICES, CHEMICAL-SYNTHETIC

Region: Europe

ألمانيا

Glatt Pharmaceutical Services GmbH Co. & KG

شركة CDMO المتوافقة مع cGMP للخدمات الشاملة في مجال أشكال جرعات المواد الصلبة الفموية المعقدة، ومقرها في Binzen بألمانيا.

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Batch Size: Large, Small, Medium

Use: Human, Veterinary

BSL (Biological Safety Level): 1

Markets: FDA (USA), EMA (EU)

Services: Development services, Analytical / QC services, Manufacturing services

Compliance: FDA (cGMP), EMA (EU GMP)

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use

Therapeutic Areas of Expertise (ATC): (B) Blood and blood forming organs, (J) Antiinfectives for systemic use, (N) Nervous system, (S) Sensory organs, (V06) Nutrients, (R) Respiratory system, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (H) Systemic hormonal preparations excl. sex hormones and insulins, (C) Cardiovascular system, (A) Digestive tract and metabolism

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Category / Product: FDF / DRUG PRODUCTS

Region: Europe

فرنسا

Adragos Pharma | Livron

Adragos Pharma

صناعة السوائل والتحاميل المعقمة. نحن نتعامل مع أكثر من 100 جزيء، وإدارة المخدرات، وخدمات التحليل والاستقرار.

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Batch Size: Large, Small, Medium

Use: Human

Markets: EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), CDSCO (India), MFDS (South Korea), TGA (Australia)

Services: Logistics, Analytical / QC services, Regulatory services, Packaging, Manufacturing services, Quality Assurance services

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use

Compliance: EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

Category / Product: FDF / DRUG PRODUCTS

Region: Europe

تركيا

GENSENTA ILAC SANAYI AS

GENSENTA

الشركة المصنعة لـ CMO و CDMO و FDF

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Batch Size: Large, Small, Medium

Use: Human

Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities, SFDA (Saudi Arabia), TGA (Australia)

Services: Development services, Analytical / QC services, Packaging, Manufacturing services, Quality Assurance services

Compliance: ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), PMDA/MHLW (Japan GMP), TITCK (Turkish Health Authorities), TGA (Australia GMP), Health Canada (Canada GMP), MHRA (UK GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), SFDA (Saudi Food & Drug Authority)

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse, High potential for abuse & medical use

Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Category / Product: FDF / DRUG PRODUCTS, SERVICES

Region: Europe

كيفية اختيار شركات HPAPI CDMO

<ص> عند تقييم شركات HPAPI CDMO، من الضروري النظر إلى ما هو أبعد من الإمكانات القياسية. تشمل عوامل الاختيار الرئيسية ما يلي:

البنية التحتية للاحتواء: OEB 4–5 / OEL
الخبرة مع فئات جزيئات معينة: واجهات برمجة التطبيقات الخاصة بعلم الأورام، والمواد السامة للخلايا، والهرمونات، والمنشطات، ومثبطات المناعة
مجموعات HPAPI المخصصة لتجنب التلوث المتبادل
قابلية التوسع من التطوير على نطاق جرامي إلى دفعات تجارية متعددة الكيلوات
بروتوكولات التحقق من صحة التنظيف المتخصصة وتحليلات الكشف عن مستوى التتبع
سجل المسار التنظيمي مع ملفات HPAPI (FDA، EMA، PMDA، وما إلى ذلك)

<ص> يتطلب تصنيع HPAPI الدقة العلمية والتميز الهندسي، وليس الامتثال فحسب، بل الإتقان أيضًا.

الخدمات الأساسية التي يقدمها موفرو خدمات تصنيع واجهة برمجة التطبيقات (API) ذوي الكفاءة العالية

<ص> تشتمل عادةً خدمات تصنيع واجهة برمجة التطبيقات (API) ذات المستوى الأعلى على ما يلي:

تطوير العمليات وتحسينها في ظل الاحتواء العالي
التوليف على نطاق صغير وواسع النطاق من واجهات برمجة التطبيقات السامة للخلايا والهرمونات
نقل التكنولوجيا وتوسيع نطاقها في الأنظمة المغلقة والمحتوية
تطوير الأساليب التحليلية بما في ذلك الكشف عن الشوائب على مستوى التتبع
التعامل القوي والتصغير تحت الاحتواء
دراسات الاستقرار والتحقق من صحة التنظيف
وثائق GMP ودعم سجلات الدُفعات
دعم التقديمات التنظيمية عبر الأسواق الرئيسية

<ص> تساعدك هذه الخدمات على التأكد من أن تصنيع HPAPI آمن وفعال ومتوافق عالميًا.

مزايا الشراكة مع شركات HPAPI CDMO

<ص> يوفر التعاون مع شركات HPAPI CDMO المتخصصة فوائد استراتيجية وتشغيلية متعددة:

سلامة المشغل والبيئة من خلال الاحتواء المتقدم
تطوير أسرع باستخدام منصات HPAPI وقوالب العمليات المعتمدة
تركيب عالي الإنتاجية مع التحكم في الشوائب
انخفاض خطر التلوث المتبادل من خلال مناطق HPAPI المخصصة
الاستعداد التنظيمي مع العمليات التي تم التحقق من صحتها والمواقع التي أثبتت كفاءتها في التدقيق

<ص> مع الشريك المناسب، يمكنك بثقة تطوير وتصنيع مركبات قوية دون المساس بالسلامة أو السرعة.