Aenova Group - Location Killorglin, Ireland
Aenova
Competence Center for spray drying and modified release pellets.
MARKETS: EMA (EU), PMDA (Japan), SFDA (Saudi Arabia), MFDS (South Korea)
REGION: Europe
COMPLIANCE: ISO, PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: NUTRACEUTICALS, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
USE: Human, Veterinary
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
Aenova Group - Location Gronau, Germany
Aenova
Competence center for conventional solids and clinical services.
MARKETS: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, EDE (UAE)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), UAE Ministry of Health & Prevention, EMA (EU GMP)
BATCH SIZE: Large, Small, Medium
USE: Human, Veterinary
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
SERVICES: Logistics, Manufacturing services, Packaging
MARKETS: FDA (USA), Health Canada (Canada)
COMPLIANCE: FDA (cGMP), Halal Research Council, Health Canada (Canada GMP), NSF
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: NUTRACEUTICALS
USE: Human
REGION: North America
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 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
Aenova Group - Location Cornu, Romania
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 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
Aenova Group - Location Bad Aibling, Germany
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 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
Aenova Group - Location Carugate, Italy
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 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 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
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), FDA (USA), Health Canada (Canada), MHRA (UK)
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, EMA (EU GMP)
BATCH SIZE: Large, Small, Medium
USE: Human, Veterinary
SERVICES: Development services, Manufacturing services, Analytical / QC services
THERAPEUTIC AREAS OF EXPERTISE (ATC): (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (N) Nervous system
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
53Biologics Production Plant
53Biologics
53Biologics is a Spanish CDMO specialized in decoding the production of biologicals, from DNA to proteins.
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
TRADICHEM INDUSTRIAL SERVICES
TRADICHEM INDUSTRIAL SERVICES S.L.
HIPERING® TECHNOLOGY - THE GATEWAY FOR LEAN MANUFACTURING
MARKETS: EMA (EU), FDA (USA)
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: NUTRACEUTICALS, SERVICES, PARTICLE ENGINEERING
USE: Human, Veterinary
BSL (Biological Safety Level): 1, 2
SERVICES: Development services, Manufacturing services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 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), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)
REGION: Europe
BATCH SIZE: Large, Small, Medium
USE: Human
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (A) Digestive tract and metabolism
COMPLIANCE: ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), PMDA/MHLW (Japan GMP), MHRA (UK GMP), EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CATEGORY / PRODUCT: SERVICES, FDF / DRUG PRODUCTS
COMPLIANCE: French Service-Public (CIR), EMA (EU GMP), FDA (cGMP), ISO, SFDA (Saudi Food & Drug Authority)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
BSL (Biological Safety Level): 3, 1, 2
MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)
REGION: Europe
USE: Human, Veterinary
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services