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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
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
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
Adragos Pharma | Leipzig
Adragos Pharma
Productos farmacéuticos semisólidos y líquidos no estériles. Con más de 100 a os de experiencia, contamos con un historial de prestación de servicios de primera
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
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, SERVICES
USE: Human, Veterinary
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)
COMPLIANCE: EMA (EU GMP)
Apeloa Pharmaceutical Co., Ltd.
Apeloa Pharmaceutical Co., Ltd
Apeloa CDMO ofrece servicios de primer nivel en descubrimiento, desarrollo y fabricación de Ingredientes Farmacéuticos Activos (APIs), Intermedios y Materiales
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
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), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia)
REGION: APAC
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ECOVADIS, NMPA (China GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, SERVICES
USE: Human, Veterinary
SERVICES: Development services, Manufacturing services, Analytical / QC services, Regulatory services, Packaging
Pharmaron API Commercial Synthesis Cramlington (UK)
Pharmaron
Instalación comercial de moléculas peque as (RSM/API)
THERAPEUTIC AREAS OF EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (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, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
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), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
REGION: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC
USE: Human, Veterinary
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)
White Raven - Legiapark
White Raven
Fill and finish site dedicated to GMP Formulation and the Aseptic filling of Sterile Liquid Injectables.
MARKETS: EMA (EU)
REGION: Europe
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, SERVICES
USE: Human
BSL (Biological Safety Level): 1, 2
SERVICES: Manufacturing services, Packaging
BATCH SIZE: Small, Medium
COMPLIANCE: EMA (EU GMP)
Indena Settala
Indena
Nuestra instalación totalmente conforme con GMP y aprobada por la FDA, ubicada en Settala (a 20 minutos de Milán), está especializada en APIs complejos y compue
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), 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), Turkish Health Authorities, 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), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, SERVICES
USE: Human, Veterinary
Rodon Biologics
Rodon Biologics - RDN Serviços de Biotecnologia
Rodon Biologics ofrece excelencia en el desarrollo de productos biofarmacéuticos para terceros.
REGION: Europe
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, NUTRACEUTICALS, OLIGONUCLEOTIDES, BIOLOGICS, SERVICES
USE: Human
BSL (Biological Safety Level): 1, 2
SERVICES: Development services, Manufacturing services, Analytical / QC services
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
BATCH SIZE: Small
CDMO/CMO facility
MAI network supplier
CDMO de APIs de molécula pequeña que ofrece desarrollo de procesos, escalado, soporte analítico y servicios de fabricación bajo normativa GMP de la UE para empresas farmacéuticas y biotecnológicas.
Location available after registration
CHEMICAL-SYNTHETIC manufacturing site
MAI network supplier
Centro de I+D
Location available after registration
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