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Discover highly skilled partners for your drug development and manufacturing project.
Belgium
White Raven - Legiapark
White Raven
Fill and finish site dedicated to GMP Formulation and the Aseptic filling of Sterile Liquid Injectables.
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), 1 / low-hazard (PDE > 10,000 µg/day)
MARKETS: EMA (EU)
REGION: Europe
USE: Human
BSL (Biological Safety Level): 1, 2
SERVICES: Manufacturing services, Packaging
BATCH SIZE: Small, Medium
COMPLIANCE: EMA (EU GMP)
CATEGORY / PRODUCT: BIOLOGICS, FDF / DRUG PRODUCTS
United Kingdom
Upperton Pharma Solutions
Upperton Pharma Solutions
Development and manufacturing of oral solid dose (OSD), nasal, inhalation, and sterile dry powders and liquids drug products.
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), 1 / low-hazard (PDE > 10,000 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), FDA (USA), Health Canada (Canada), MHRA (UK), TGA (Australia)
REGION: Europe
USE: Human
CATEGORY / PRODUCT: OLIGONUCLEOTIDES, BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS
BSL (Biological Safety Level): 1
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (N) Nervous system, (R) Respiratory system
BATCH SIZE: Small, Medium
COMPLIANCE: MHRA (UK GMP)
Spain
VIVEbiotech
VIVEbiotech
Your leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors.
MARKETS: EMA (EU), FDA (USA), MHRA (UK)
REGION: Europe
COMPLIANCE: FDA (cGMP), French Service-Public (CIR), EMA (EU GMP), MHRA (UK GMP)
BATCH SIZE: Large, Small, Medium
USE: Human
BSL (Biological Safety Level): 1, 2
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
CATEGORY / PRODUCT: BIOLOGICS
Spain
HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
End-to-end internal capabilities from cell line development to commercial manufacturing.
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
COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
BATCH SIZE: Large, Small, Medium
USE: Human, Veterinary
BSL (Biological Safety Level): 1, 2
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)
CATEGORY / PRODUCT: BIOLOGICS, FDF / DRUG PRODUCTS
Spain
53Biologics Production Plant
53Biologics
53Biologics is a Spanish CDMO specialized in decoding the production of biologicals, from DNA to proteins.
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
USE: Human, Veterinary
BSL (Biological Safety Level): 1, 2
CATEGORY / PRODUCT: BIOLOGICS
Spain
BDI biotech Production Plant
BDI biotech
We work as an R&D department specialized in strain and bioprocess development, scale-up and batches production.
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: ISO
BSL (Biological Safety Level): 1
BATCH SIZE: Small, Medium
CATEGORY / PRODUCT: BIOLOGICS
Spain
Cultiply
Cultiply
Spanish CDMO that develops production and purification processes for recombinant proteins, enzymes, DNA and other bioderived products.
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
BSL (Biological Safety Level): 1, 2
SERVICES: Development services, Manufacturing services
CONTROLLED SUBSTANCES: Lowest potential for abuse
BATCH SIZE: Small, Medium
CATEGORY / PRODUCT: BIOLOGICS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
Netherlands
Bilthoven Biologicals Drug Substance and Drug Product Facilities
Bilthoven Biologicals
Multi-product GMP facilities for Drug Substance and Drug Product.
MARKETS: EMA (EU), MHRA (UK)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
BATCH SIZE: Large, Small, Medium
USE: Human
BSL (Biological Safety Level): 1, 2
COMPLIANCE: EMA (EU GMP)
CATEGORY / PRODUCT: BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS
Portugal
Rodon Biologics
Rodon Biologics - RDN Serviços de Biotecnologia
Rodon Biologics provides excellence in the development of biopharmaceutical products for third parties.
REGION: Europe
CATEGORY / PRODUCT: NUTRACEUTICALS, BIOLOGICS, SERVICES
BSL (Biological Safety Level): 1, 2
SERVICES: Development services, Analytical / QC services
BATCH SIZE: Small
Spain
HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes
HISTOCELL
Histocell is a Spanish CDMO that develops and manufactures cell therapies, secretomes and exosomes, as well medical devices.
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
MARKETS: MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), CDSCO (India), TGA (Australia), EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities
BATCH SIZE: Small, Medium
COMPLIANCE: EMA (EU GMP), ISO
CATEGORY / PRODUCT: BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS, COSMETICS
REGION: Europe
USE: Human, Veterinary
BSL (Biological Safety Level): 1, 2
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services
Spain
HIPRA BIOTECH SERVICES | Aiguaviva
HIPRA Biotech Services
End-to-end internal capabilities from cell line development to commercial manufacturing.
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
COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
BATCH SIZE: Large, Small, Medium
USE: Human
BSL (Biological Safety Level): 1, 2
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)
CATEGORY / PRODUCT: BIOLOGICS
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
USE: Human
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use, (R) Respiratory system, (G) Genito urinary system and sex hormones
CATEGORY / PRODUCT: BIOLOGICS, FDF / DRUG PRODUCTS
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