
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, ANALYTICAL CRO
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 - 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

Cenexi
The Hérouville-Saint-Clair site, located near Caen, in Normandy, specializes in the manufacture and filling of injectable and non-injectable sterile liquids.
Batch Size: Small, Medium
Category / Product: FDF / DRUG PRODUCTS
Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MHRA (UK 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
Markets: ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), MHRA (UK)
Use: Human
Services: Analytical / QC services, Manufacturing services, Regulatory services, Packaging, Quality Assurance services
Therapeutic Areas of Expertise (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

CONTENT GROUP
Tubilux Pharma: registered office; manufacturing facility.
Batch Size: Medium, Large
Category / Product: FDF / DRUG PRODUCTS, ANALYTICAL CRO
Compliance: Roszdravnadzor (Russia GMP), EMA (EU GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), FDA (cGMP), TITCK (Turkish Health Authorities)
Region: Europe
Markets: ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU), TGA (Australia)
Use: Human, Veterinary
Therapeutic Areas of Expertise (ATC): (S) Sensory organs

CONTENT GROUP
COC Farmaceutici srl: commercial and administrative headquarters; manufacturing facility.
Batch Size: Medium, Large
Category / Product: FDF / DRUG PRODUCTS, COSMETICS, ANALYTICAL CRO
Markets: EDE (UAE), EMA (EU), SFDA (Saudi Arabia), MHRA (UK)
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Compliance: ISO
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Israeli CDMO specialized in the development and GMP manufacturing of complex synthetic drug products and chemistry-based medical devices.
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We can take your pharmaceuticals from lab scale to the early clinical phase and beyond.
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