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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
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
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
Lifecore Injectables CDMO
Lifecore Biomedical
CDMO that manufactures clinical & commercial sterile injectable drug products.
BSL (Biological Safety Level): 3, 1, 2
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
COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea 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
CONTROLLED SUBSTANCES: Lowest potential for abuse
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)
REGION: North America
Green Phoenix Labs GmbH
Green Phoenix Labs GmbH
Cell Therapy company with excess Cleanroom capacity
MARKETS: EMA (EU)
SERVICES: Logistics, Development services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES
USE: Human
BSL (Biological Safety Level): 1
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
CONTROLLED SUBSTANCES: Lowest potential for abuse, Low potential for abuse
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
COMPLIANCE: EMA (EU GMP)
Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site
Seacross Pharmaceutical Co Ltd
As one of three core sites, alongside the R&D center and formulation plant, our API manufacturing facility plays a vital role in the integrated supply chain.
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, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
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, 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), 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: APAC
COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP), SQF (Safe Quality Food), NSF
BATCH SIZE: Large, Small, Medium
CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES, BIOLOGICS
USE: Human
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 > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
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
BAG Health Care
BAG Health Care GmbH
Proveedor de servicios de llenado y acabado (F&F) para viales en lotes pequeños y medianos.
MARKETS: EMA (EU), MHRA (UK), TGA (Australia)
REGION: Europe
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES
USE: Human, Veterinary
BSL (Biological Safety Level): 1
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
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)
BATCH SIZE: Small, Medium
COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
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
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
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