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Lifecore Injectables CDMO
Lifecore Biomedical
CDMO that manufactures clinical & commercial sterile injectable drug products.
MARKETS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
COMPLIANCE: EMA (EU GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
CONTROLLED SUBSTANCES: Lowest potential for abuse
BSL (Biological Safety Level): 3, 1, 2
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 - 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)
REGION: North America
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
BAG Health Care
BAG Health Care GmbH
Proveedor de servicios de llenado y acabado (F&F) para viales en lotes pequeños y medianos.
BATCH SIZE: Small, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
REGION: Europe
USE: Human, Veterinary
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
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)
BSL (Biological Safety Level): 1
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
MARKETS: EMA (EU), TGA (Australia), MHRA (UK)
CARBOGEN AMCIS | Saint-Beauzire
CARBOGEN AMCIS
Desarrollo personalizado y producción aséptica automatizada de medicamentos líquidos y liofilizados
MARKETS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium, Large
THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
COMPLIANCE: ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), SFDA (Saudi Food & Drug Authority), ISO, Health Canada (Canada 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, 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)
CARBOGEN AMCIS | Aarau
CARBOGEN AMCIS
Desarrollo y fabricación cGMP a mediana escala, incluida la cromatografía
BATCH SIZE: Small, Medium
COMPLIANCE: PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO
CATEGORY / PRODUCT: SERVICES, OLIGONUCLEOTIDES, BIOLOGICS, CHEMICAL-SYNTHETIC
REGION: Europe
MARKETS: ANVISA (Brazil), PMDA (Japan), FDA (USA), CDSCO (India), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
USE: Human, Veterinary
SERVICES: Analytical / QC services, Manufacturing services, Development services, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
Adragos Pharma | Halden
Adragos Pharma
Nos especializamos en la fabricación de bolsas intravenosas, ampollas y viales de plástico utilizando la tecnología Blow-Fill-Seal (BFS) y otras formas de dosif
MARKETS: Turkish Health Authorities, EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), MHRA (UK)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, OLIGONUCLEOTIDES, BIOLOGICS, NUTRACEUTICALS, CHEMICAL-SYNTHETIC
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), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (China GMP), ISO, TITCK (Turkish Health Authorities), 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, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents, (A) Digestive tract and metabolism, (D) Dermatologicals, (V06) Nutrients
Aenova Group - Location Gronau, Germany
Aenova
Centro de competencia para sólidos convencionales y servicios clínicos.
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), FDA (cGMP)
MARKETS: EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU)
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 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
Cenexi Hérouville Saint Clair
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, BIOLOGICS, CHEMICAL-SYNTHETIC
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)
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, Development services, Packaging, Quality Assurance services
THERAPEUTIC AREAS OF EXPERTISE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (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)
CONTROLLED SUBSTANCES: High potential for abuse & no medical use, High potential for abuse & medical use
CARBOGEN AMCIS | Bubendorf
CARBOGEN AMCIS
Desarrollo y fabricación cGMP de API de gran potencia, incluidos conjugados anticuerpo-fármaco (ADC)
MARKETS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium
THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (B) Blood and blood forming organs
COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO
CATEGORY / PRODUCT: SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
REGION: Europe
USE: Human, Veterinary
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Quality Assurance services
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)
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, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
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
VIVEbiotech
VIVEbiotech
Su CDMO líder con certificación GMP dedicada exclusivamente a la producción de vectores lentivirales.
BATCH SIZE: Small, Medium, Large
COMPLIANCE: EMA (EU GMP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP)
CATEGORY / PRODUCT: SERVICES, OLIGONUCLEOTIDES, BIOLOGICS, CHEMICAL-SYNTHETIC
REGION: Europe
USE: Human
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
MARKETS: FDA (USA), EMA (EU), TGA (Australia)
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
MARKETS: Turkish Health Authorities, ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, OLIGONUCLEOTIDES, BIOLOGICS, CHEMICAL-SYNTHETIC
CONTROLLED SUBSTANCES: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
REGION: Europe
USE: Human
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), 3 (PDE = 100 - 1,000 µg/day)
SERVICES: Manufacturing services, Regulatory services, Development services, Packaging
COMPLIANCE: FDA (cGMP), ISO
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
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
BATCH SIZE: Small, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
COMPLIANCE: EMA (EU GMP), FDA (cGMP)
REGION: Europe
USE: Human
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
MARKETS: PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), NMPA (China), Health Canada (Canada), MHRA (UK)
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
CONTROLLED SUBSTANCES: High potential for abuse & no medical use
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
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