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Greece
Adragos Pharma | Athens
Adragos Pharma
Specializes in the development of Value Added Medicines and has been recently upgraded with HPAPI capabilities.
MARKETS: ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), CDSCO (India), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES
COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), NSF, NMPA (China GMP), ISO, MFDS/KFDA (Republic of Korea GMP)
CONTROLLED SUBSTANCES: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
REGION: Europe
USE: Human
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Japan
Adragos Pharma | Kawagoe
Adragos Pharma
Our facility provides best-in-class manufacturing of tablets and ampoules.
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES
MARKETS: EDE (UAE), PMDA (Japan), FDA (USA), CDSCO (India), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), FDA (cGMP)
BATCH SIZE: Large
CONTROLLED SUBSTANCES: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
USE: Human
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Packaging, Quality Assurance services
REGION: APAC
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
France
Adragos Pharma | Livron
Adragos Pharma
Manufacture of sterile liquids and suppositories. We handle more than 100 molecules, narcotics management, and analysis and stability services.
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
COMPLIANCE: EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
CONTROLLED SUBSTANCES: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
REGION: Europe
USE: Human
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Packaging, Quality Assurance services
MARKETS: PMDA (Japan), CDSCO (India), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), MHRA (UK)
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
MARKETS: Turkish Health Authorities, ANVISA (Brazil), EMA (EU), SFDA (Saudi Arabia), NMPA (China), MHRA (UK)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
COMPLIANCE: EMA (EU GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), SFDA (Saudi Food & Drug Authority), ISO, TITCK (Turkish Health Authorities), ICH
REGION: Europe
BSL (Biological Safety Level): 3, 4
USE: Human
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
CONTROLLED SUBSTANCES: High potential for abuse & medical use
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
France
Cenexi
Cenexi
GMP plant on a four-hectare site is located 9 km east of Paris. It is a center of excellence for injectable ampoules.
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
MARKETS: EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), NMPA (China GMP), MFDS/KFDA (Republic of Korea GMP)
CONTROLLED SUBSTANCES: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
REGION: Europe
USE: Human, Veterinary
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
THERAPEUTIC AREAS OF EXPERTISE (ATC): (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
CDM Lavoisier is specialized in the manufacturing of glass ampoules, glass vials and plastic (BFS) ampoules.
Location available after registration
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
CMO combining advanced facilities, stringent QC, and expert staff to deliver reliable, compliant, and innovative solutions.
Location available after registration
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Contract research and development laboratory (CRDO) based in USA that provides pharmaceutical product development services.
Location available after registration
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FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Solutions for non Viral Delivery programs
Location available after registration
Spain
Laboratorios Grifols | Murcia Plant
Grifols International
Sterile manufacturing solutions (small molecules) in flexible bags.
MARKETS: ANMAT (Argentina), ANVISA (Brazil), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
COMPLIANCE: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, INVIMA, Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
CONTROLLED SUBSTANCES: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
REGION: Europe
USE: Human, Veterinary
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
THERAPEUTIC AREAS OF EXPERTISE (ATC): (M) Musculoskeletal system, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system
Spain
Laboratorios Grifols | Barcelona Plant
Grifols International
Sterile manufacturing solutions (small molecules) in flexible bags and vials.
MARKETS: ANMAT (Argentina), ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada), MHRA (UK)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
COMPLIANCE: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, INVIMA, Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
CONTROLLED SUBSTANCES: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
REGION: Europe
USE: Human, Veterinary
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
THERAPEUTIC AREAS OF EXPERTISE (ATC): (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Integrated development and cGMP manufacturing site.
Location available after registration
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
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Location available after registration
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
mRNA & LNP manufacturing and Fill and Finish.
Location available after registration