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)
Aenova Group - Location Carugate, Italy
Aenova
Centro de competencia Semisólidos y líquidos no estériles.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 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: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, COSMETICS
USE: Human, Veterinary
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
THERAPEUTIC AREAS OF EXPERTISE (ATC): (D) Dermatologicals, (P) Antiparasitic products, insecticides and repellents
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
Viswa Laboratories Pvt Ltd
Viswa Laboratories Private Limited
CRAMS/CDMO, API, Productos intermedios y especialidades químicas
MARKETS: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, CDSCO (India)
REGION: APAC, Europe
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, SERVICES
USE: Human, Veterinary
BSL (Biological Safety Level): 2
SERVICES: Development services, Manufacturing services, Regulatory services
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (R) Respiratory system
CONTROLLED SUBSTANCES: Lower potential for abuse
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day)
COMPLIANCE: World Health Organization (GMP / HACCP)
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 > 10,000 µg/day)
Pharmaron API Commercial Synthesis Coventry (US)
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), MHRA (UK), MFDS (South Korea), TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services
COMPLIANCE: FDA (cGMP), ISO, ECOVADIS
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, SERVICES
USE: Human, Veterinary
OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
REGION: North America
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
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
Adragos Pharma | Livron
Adragos Pharma
Fabricación de líquidos estériles y supositorios. Manejamos más de 100 moléculas y ofrecemos estudios de estabilidad, manejo de narcóticos y servicios de anális
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
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), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)
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, COSMETICS, SERVICES
USE: Human
THERAPEUTIC AREAS OF EXPERTISE (ATC): (D) Dermatologicals
COMPLIANCE: EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
CHEMICAL-SYNTHETIC manufacturing site
MAI network supplier
Sitio de desarrollo y fabricación de sustancias activas de peque as moléculas
Location available after registration
These facilities match your main criteria but not all optional filters.
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
CDM Lavoisier está especializada en la fabricación de ampollas de vidrio, viales de vidrio y ampollas de plástico (BFS).
Location available after registration
SERVICES manufacturing site
MAI network supplier
Cambrex High Point se centra en el desarrollo y la fabricación de ingredientes farmacéuticos activos (API) para apoyar los ensayos clínicos de Fase I a Fase III, así como la fabricación comercial a…
Location available after registration
SERVICES manufacturing site
MAI network supplier
Cambrex Agawam ofrece un conjunto completo de servicios de control microbiológico, analítico y medioambiental para apoyar el desarrollo de productos farmacéuticos y dispositivos médicos.
Location available after registration
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Liofilizados y líquidos Dos salas blancas BSL-2 conformes con el Anexo I, una zona de contención dedicada y capacidad de hasta 50 L de volumen a granel. Dos sistemas de liofilización con…
Location available after registration
SERVICES manufacturing site
MAI network supplier
CDMO espa ola que desarrolla procesos de producción y purificación de proteínas recombinantes, enzimas, ADN y otros productos bioderivados.
Location available after registration
CDMO/CMO facility
MAI network supplier
Planta de inhalación de polvo seco
Location available after registration