
Markets: EMA (EU), FDA (USA), Russian Health Authorities
Region: Europe
Compliance: FDA (cGMP), ISO, Roszdravnadzor (Russia GMP), EMA (EU GMP)
Batch Size: Large, Small, Medium
Category / Product: COSMETICS, FDF / DRUG PRODUCTS
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system
OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)

Aenova
Competence Center and one-stop shop for Soft gelatin capsules and VegaGels®.
Region: Europe
Markets: FDA (USA), Health Canada (Canada), TGA (Australia)
Compliance: FDA (cGMP), ISO, Halal Research Council, TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP)
Batch Size: Large, Small, Medium
Category / Product: NUTRACEUTICALS, FDF / DRUG PRODUCTS
Use: Human
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
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)

Aenova
Competence Center Blister packaging Third party packaging High volume plant for effervescents.
Markets: EMA (EU), FDA (USA)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
Region: Europe
Compliance: FDA (cGMP), ISO, IFS, EMA (EU GMP)
Batch Size: Large, Small, Medium
Category / Product: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS
Use: Human, Veterinary
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)

Aenova
Competence Center Semisolids and non-sterile liquids.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
Markets: EMA (EU), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia)
Region: Europe
Compliance: ISO, Roszdravnadzor (Russia GMP), SFDA (Saudi Food & Drug Authority), EMA (EU GMP)
Batch Size: Large, Small, Medium
Category / Product: COSMETICS, FDF / DRUG PRODUCTS
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
Region: Europe

Adragos Pharma
Specialised in prefilled syringes, liquid and lyophilised vials, it combines advanced aseptic filling, freeze-drying, and inspection systems.
Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (A) Digestive tract and metabolism
Markets: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities
Region: Europe
Batch Size: Large
Use: Human
BSL (Biological Safety Level): 1
Services: Manufacturing services, Analytical / QC services, Regulatory services, Packaging
Controlled Substances: Lowest potential for abuse
Compliance: ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
Category / Product: FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)

Adragos Pharma
Non-sterile semi-solid and liquid pharmaceutical products.
Controlled Substances: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
Markets: EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), MFDS (South Korea)
Services: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Batch Size: Large, Small, Medium
Use: Human, Veterinary
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)
Compliance: EMA (EU GMP)
Category / Product: FDF / DRUG PRODUCTS

Adragos Pharma
We specialize in the manufacturing of IV bags, plastic ampoules and vials using Blow-Fill-Seal (BFS) technology and other dosage forms.
Controlled Substances: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
Markets: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), TGA (Australia)
Services: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP), NSF
Batch Size: Large, Small, Medium
Use: Human
Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (V06) Nutrients, (A) Digestive tract and metabolism
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

Adragos Pharma
Specializes in the development of Value Added Medicines and has been recently upgraded with HPAPI capabilities.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
Controlled Substances: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
Markets: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP), NSF
Batch Size: Large, Small, Medium
Use: Human
Category / Product: SERVICES, FDF / DRUG PRODUCTS

Adragos Pharma
We specialize in aseptic manufacturing of lyophilized or liquid sterile (bio)pharmaceutical drug products through fill and finish.
Markets: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), MHRA (UK), MFDS (South Korea)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: FDA (cGMP), EMA (EU GMP)
Use: Human
Controlled Substances: High potential for abuse & no medical use
Batch Size: Small, Medium
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

Adragos Pharma
Manufacture of sterile liquids and suppositories. We handle more than 100 molecules, narcotics management, and analysis and stability services.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
Controlled Substances: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse
Markets: EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)
Services: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Batch Size: Large, Small, Medium
Use: Human
Compliance: EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
Category / Product: FDF / DRUG PRODUCTS

Glatt Pharmaceutical Services GmbH Co. & KG
Your cGMP-compliant CDMO for end-to-end services in the complex oral solids dosage forms field, based in Binzen Germany.
Controlled Substances: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse
Markets: EMA (EU), FDA (USA)
Region: Europe
Compliance: FDA (cGMP), EMA (EU GMP)
Batch Size: Large, Small, Medium
Use: Human, Veterinary
BSL (Biological Safety Level): 1
Services: Development services, Manufacturing services, Analytical / QC services
Therapeutic Areas of Expertise (ATC): (C) Cardiovascular system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism
OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/day), 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
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