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Spain
Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
LABORATORIO REIG JOFRE SA
Injectable (lyo and liquid) and Liquid manufacturing facilities.
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
Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC
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): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Spain
HIPRA BIOTECH SERVICES | Aiguaviva
HIPRA Biotech Services
Capacidades internas de principio a fin, desde el desarrollo de líneas celulares hasta la fabricación comercial.
Markets: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
Batch Size: Large, Small, Medium
Category / Product: CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES, BIOLOGICS, SERVICES
Use: Human, Veterinary
BSL (Biological Safety Level): 1, 2
Therapeutic Areas of Expertise (ATC): (L) Antineoplastic and immunomodulating agents
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Region: Europe
Category / Product: OLIGONUCLEOTIDES, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, COSMETICS, SERVICES
Use: Human
Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ISO, EMA (EU GMP), French Service-Public (CIR), ECOVADIS, World Health Organization (GMP / HACCP), MHRA (UK GMP), NMPA (China GMP), TGA (Australia GMP), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), MFDS/KFDA (Republic of Korea GMP), ISP (Chile BPM), INVIMA, MSPAS, COFEPRIS, DIGEMID, Health Canada (Canada GMP)
Services: Development services, Manufacturing services, Analytical / QC services, Regulatory services, Packaging, Logistics, Quality Assurance services
Batch Size: Small, Large, Medium
Markets: FDA (USA), EMA (EU), PMDA (Japan), ANVISA (Brazil), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), EDE (UAE)
Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (A) Digestive tract and metabolism, (C) Cardiovascular system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
BSL (Biological Safety Level): 3, 4
Controlled Substances: High potential for abuse & medical use
Compliance: ICH, ISO, ANVISA (Brazil B-GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (China GMP), EMA (EU GMP)
Markets: EMA (EU), NMPA (China), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Batch Size: Large, Small, Medium
Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES
Use: Human
Therapeutic Areas of Expertise (ATC): (L) Antineoplastic and immunomodulating agents
Region: Europe
Category / Product: PARTICLE ENGINEERING, SERVICES, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC
Services: Development services, Manufacturing services, Regulatory services
Use: Human, Veterinary
Batch Size: Small, Medium
Therapeutic Areas of Expertise (ATC): (A) Digestive tract and metabolism, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (P) Antiparasitic products, insecticides and repellents, (G) Genito urinary system and sex hormones
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
BSL (Biological Safety Level): 1, 2, 3
Compliance: ISO, EMA (EU GMP), FDA (cGMP), World Health Organization (GMP / HACCP)
Markets: FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), EDE (UAE), SFDA (Saudi Arabia), Turkish Health Authorities
Spain
VIVEbiotech
VIVEbiotech
Su CDMO líder con certificación GMP dedicada exclusivamente a la producción de vectores lentivirales.
Region: Europe
Category / Product: OLIGONUCLEOTIDES, CHEMICAL-SYNTHETIC, SERVICES, BIOLOGICS
Use: Human
Compliance: EMA (EU GMP), FDA (cGMP), TGA (Australia GMP), French Service-Public (CIR), MHRA (UK GMP)
Services: Development services, Manufacturing services, Analytical / QC services, Regulatory services, Packaging, Quality Assurance services
Batch Size: Large, Small, Medium
Markets: FDA (USA), EMA (EU), TGA (Australia)
Therapeutic Areas of Expertise (ATC): (L) Antineoplastic and immunomodulating agents
BSL (Biological Safety Level): 1, 2
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)
Markets: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities
Region: Europe
Compliance: FDA (cGMP), ISO
Batch Size: Large, Small, Medium
Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES, BIOLOGICS, SERVICES
Use: Human
Services: Development services, Manufacturing services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (L) Antineoplastic and immunomodulating agents
Controlled Substances: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
Switzerland
Adragos Pharma | Jura
Adragos Pharma
Nos especializamos en la fabricación aséptica de productos farmacéuticos y biofarmacéuticos estériles, liofilizados o líquidos, mediante procesos de llenado y a
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)
Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES
Use: Human
Therapeutic Areas of Expertise (ATC): (L) Antineoplastic and immunomodulating agents
Controlled Substances: High potential for abuse & no medical use
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Batch Size: Small, Medium
Spain
Adare Pharma | US
Adare Pharma Solutions
Adare Pharma es un CDMO global con instalaciones en EE.UU. y la UE, que ofrece desarrollo de productos llave en mano mediante experiencia en fabricación comerci
Compliance: 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), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities)
Markets: SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), TGA (Australia), 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)
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
Therapeutic Areas of Expertise (ATC): (A) Digestive tract and metabolism, (C) Cardiovascular system, (D) Dermatologicals
Region: North America, Europe
Batch Size: Small, Medium, Large
Category / Product: SERVICES, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Use: Human, Veterinary
Germany
Aenova Group - Location Regensburg, Germany
Aenova
Centro de competencia sólidos de alta potencia (oncología) sólidos convencionales - semisólidos y líquidos especiales.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Markets: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities
Region: Europe
Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
Batch Size: Large, Small, Medium
Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, COSMETICS, NUTRACEUTICALS, PARTICLE ENGINEERING
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (L) Antineoplastic and immunomodulating agents
Spain
Adare Pharma | EU
Adare Pharma Solutions
Global CDMO offering turnkey product development through commercial manufacturing expertise, focused on oral dosage forms.
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)
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), 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)
Batch Size: Large, Small, Medium
Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING
Use: Human, Veterinary
Therapeutic Areas of Expertise (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V01) Allergens, (A) Digestive tract and metabolism
OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Belgium
Cenexi Laboratoires Thissen
Cenexi
This 8,000 m2 plant, with buildings dotted around a site of nearly seven hectares, is located 20 km south of Brussels and has 340 employees*.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
BSL (Biological Safety Level): 3, 4, 1, 2
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), MFDS (South Korea), TGA (Australia)
Region: Europe
Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
Batch Size: Large, Small, Medium
Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (G) Genito urinary system and sex hormones
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