전시 74 시설
독일
Glatt Pharmaceutical Services GmbH Co. & KG
Glatt Pharmaceutical Services GmbH Co. & KG
독일 Binzen에 본사를 두고 복잡한 경구용 고형제 분야의 엔드투엔드 서비스를 위한 cGMP 준수 CDMO입니다.
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
Batch Size: Large, Small, Medium
Use: Human, Veterinary
Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), ANMAT (Argentina), TGA (Australia)
Services: Development services, Logistics, Analytical / QC services, Regulatory services, Packaging, Manufacturing services, Quality Assurance services
Compliance: ISO, FDA (cGMP), ANVISA (Brazil B-GMP), INVIMA, ECOVADIS, TGA (Australia GMP), ISP (Chile BPM), 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)
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
Therapeutic Areas of Expertise (ATC): (N) Nervous system, (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), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
Region: Europe
노르웨이
Adragos Pharma | Halden
Adragos Pharma
당사는 BFS(Blow-Fill-Seal) 기술 및 기타 제형을 사용하여 IV 백, 플라스틱 앰플 및 바이알 제조를 전문으로 합니다.
Batch Size: Large, Small, Medium
Use: Human
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), TGA (Australia)
Services: Logistics, Analytical / QC services, Regulatory services, Packaging, Manufacturing services, Quality Assurance services
Compliance: ISO, FDA (cGMP), ANVISA (Brazil B-GMP), PMDA/MHLW (Japan GMP), TITCK (Turkish Health Authorities), TGA (Australia GMP), NMPA (China GMP), MHRA (UK GMP), World Health Organization (GMP / HACCP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, UAE Ministry of Health & Prevention
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, (V06) Nutrients, (A) Digestive tract and metabolism
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
Region: Europe
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, 분석 CRO
Region: Europe
프랑스
Cenexi Hérouville Saint Clair
Cenexi
노르망디 캉 근처에 위치한 Hérouville-Saint-Clair 현장은 주사용 및 비주사용 멸균액의 제조 및 충전을 전문으로 합니다.
Use: Human
Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), NMPA (China GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), ANVISA (Brazil), MHRA (UK), Russian Health Authorities, MFDS (South Korea), TGA (Australia)
Services: Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (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
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: FDF / DRUG PRODUCTS
Region: Europe
이탈리아
Adare Pharma | EU
Adare Pharma Solutions
경구용 제형에 초점을 맞춘 상업적 제조 전문 지식을 통해 턴키 제품 개발을 제공하는 글로벌 CDMO입니다.
Services: Development services, Logistics, Analytical / QC services, Packaging, 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), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), TGA (Australia)
Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, French Service-Public (CIR), NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
Use: Human, Veterinary
Batch Size: Large, Small, Medium
Therapeutic Areas of Expertise (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (V01) Allergens, (R) Respiratory system, (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, PARTICLE ENGINEERING, 분석 CRO
Region: Europe
미국
Adare Pharma | US
Adare Pharma Solutions
Adare Pharma es un CDMO 글로벌 설치는 EE.UU에 있습니다. y la UE, que ofrece desarrollo de productos llave en mano mediante experiencia en fabricación camerci
Services: Development services, Logistics, Analytical / QC services, Packaging, 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), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), TGA (Australia)
Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, French Service-Public (CIR), NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
Use: Human, Veterinary
Batch Size: Large, 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: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING, 분석 CRO
Therapeutic Areas of Expertise (ATC): (C) Cardiovascular system, (A) Digestive tract and metabolism
Region: North America
Markets: EMA (EU), FDA (USA), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)
Compliance: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
Use: Human, Veterinary
Batch Size: Large, Small, Medium
Services: Logistics, Analytical / QC services, Packaging, Quality Assurance services, Manufacturing services
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
Therapeutic Areas of Expertise (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (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), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
Region: Europe
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory 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), EDE (UAE), TGA (Australia)
Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
Use: Human, Veterinary
Batch Size: Large, Small, Medium
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Low potential for abuse
Therapeutic Areas of Expertise (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (D) Dermatologicals, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism
Category / Product: FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
Region: Europe
독일
Nexora Cell and Tissue Therapy Manufacturing Site
Green Phoenix Labs GmbH
독일에서 허가된 ATMP 사이트. 세포 및 조직 치료를 위한 GMP 제조 및 QP 배치 출시.
Services: Development services, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Markets: EMA (EU)
BSL (Biological Safety Level): 1, 2
Use: Human
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
Therapeutic Areas of Expertise (ATC): (S) Sensory organs, (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (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), 2 (PDE = 1,000 - 5,000 µg/day)
Compliance: EMA (EU GMP)
Category / Product: FDF / DRUG PRODUCTS, 분석 CRO, BIOLOGICS
Region: Europe
BSL (Biological Safety Level): 3, 1, 2
Markets: EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MHRA (UK), INVIMA (Colombia), MFDS (South Korea), TGA (Australia)
Region: Europe
Batch Size: Large, Medium
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism
Controlled Substances: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
Compliance: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ECOVADIS, INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
스페인
53Biologics Production Plant
53Biologics
53Biologics는 DNA에서 단백질에 이르기까지 생물학적 제제 생산을 해독하는 데 특화된 스페인 CDMO입니다.
Markets: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
Region: Europe
Compliance: FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)
Batch Size: Large, Small, Medium
Use: Human, Veterinary
BSL (Biological Safety Level): 1, 2
Category / Product: BIOLOGICS
Are you a pharmaceutical company seeking a reliable CMO or CDMO partner to accelerate your drug development process? Look no further than MAI CDMO Network. Our advanced search platform connects you with a vast network of qualified contract manufacturers and development organizations worldwide.
Why Choose MAI CDMO Network?
- Comprehensive Provider Directory: Discover a diverse range of CMOs and CDMOs specializing in various services, including API manufacturing, clinical trial supplies, fill-finish, packaging, and more.
- Tailored Search Capabilities: Our advanced search filters allow you to refine your search based on specific criteria such as location, capabilities, capacity, and regulatory compliance.
- Global Reach: Connect with CMOs and CDMOs from around the world to find the perfect partner for your global projects.
- Time and Cost Savings: Streamline your sourcing process and reduce time-to-market by finding the right partner on our platform.
- Enhanced Decision Making: Access detailed company profiles, case studies, and reviews to make informed decisions.
How MAI CDMO Network Works
- Create a Free Account: Sign up for a free account to access our extensive database of CMOs and CDMOs.
- Refine Your Search: Use our advanced search filters to identify providers that meet your exact requirements.
- Request Quotes: Contact selected providers directly to request quotes and learn more about their services.
- Make Informed Decisions: Compare quotes, review company profiles, and select the best partner for your project.
Key Benefits of Partnering with a CMO/CDMO
- Accelerated Time-to-Market: Leverage the expertise and resources of a CMO/CDMO to expedite your drug development process.
- Reduced Costs: Benefit from economies of scale and specialized equipment to reduce manufacturing costs.
- Improved Quality: Ensure product quality and compliance with regulatory standards through rigorous quality management systems.
- Increased Flexibility: Scale up or down production as needed to meet changing market demands.
- Focus on Core Competencies: Outsource non-core activities to free up internal resources for innovation and strategic initiatives.
Featured Services
- API Manufacturing: Source high-quality active pharmaceutical ingredients from experienced manufacturers.
- Clinical Trial Supplies: Secure reliable and compliant supplies for your clinical trials.
- Fill-Finish and Packaging: Partner with experts in sterile filling, lyophilization, and packaging to ensure product stability and patient safety.
- Analytical Testing: Access a wide range of analytical services to support your drug development program.
Ready to Find Your Ideal CMO/CDMO Partner? Register Now
Explore our platform today and discover how MAI CDMO Network can help you achieve your drug development goals.