Search and Find the CMO / CDMO You Need
Discover highly skilled partners for your drug development and manufacturing project.
Spain
HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
Capacidades internas integrales, desde el desarrollo de líneas celulares hasta la fabricación comercial
COMPLIANCE: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA
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)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES
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
USE: Human, Veterinary
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
Italy
Aenova Group - Location Latina, Italy
Aenova
Centro de Competencia de productos zoosanitarios y tecnologías estériles.
MARKETS: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS
USE: Human, Veterinary
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents, (P) Antiparasitic products, insecticides and repellents
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Germany
Aenova Group - Location Gronau, Germany
Aenova
Centro de competencia para sólidos convencionales y servicios clínicos.
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
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES
USE: Human, Veterinary
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
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)
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
Spain
BDI biotech Production Plant
BDI biotech
Trabajamos como departamento de I+D especializado en el desarrollo de cepas y bioprocesos, el escalado y la producción de lotes.
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, Regulatory services
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES
USE: Human
BSL (Biological Safety Level): 1
BATCH SIZE: Small, Medium
Spain
53Biologics Production Plant
53Biologics
53Biologics es una CDMO espa ola especializada en descifrar la producción de biológicos, desde el ADN hasta las proteínas, proporcionando desde la fase preclíni
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
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
Spain
HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes
HISTOCELL
Histocell es una CDMO espa ola que desarrolla y fabrica terapias celulares a partir de iPSCs, MSCs, secretomas, exosomas y otro tipo de células, así como dispos
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), MFDS (South Korea), CDSCO (India), TGA (Australia)
REGION: Europe
COMPLIANCE: ISO, EMA (EU GMP)
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, COSMETICS, BIOLOGICS, SERVICES
USE: Human, Veterinary
BSL (Biological Safety Level): 1, 2
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism
BATCH SIZE: Small, Medium
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
MARKETS: EMA (EU)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)
BATCH SIZE: Large, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS
USE: Human
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (R) Respiratory system, (G) Genito urinary system and sex hormones
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
Spain
CZ Vaccines | Large Scale Plant Spain
CZ Vaccines
Instalación Comercial de Escala Comercial de Uso Único
MARKETS: EMA (EU)
SERVICES: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)
BATCH SIZE: Large, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES, BIOLOGICS, PARTICLE ENGINEERING
USE: Human
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones
Spain
Cellex Cell Professionals
Cellex Cell Professionals
Planta de fabricación de terapias celulares (CGT CDMO) y centro de recogida de materiales de partida
MARKETS: EMA (EU), FDA (USA)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), EMA (EU GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES
USE: Human, Veterinary
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (B) Blood and blood forming organs