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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.
BATCH SIZE: Small, Medium
THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (C) Cardiovascular system, (N) Nervous system
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, OLIGONUCLEOTIDES, BIOLOGICS
CONTROLLED SUBSTANCES: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
REGION: Europe
USE: Human
COMPLIANCE: MHRA (UK GMP)
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
MARKETS: FDA (USA), EMA (EU), TGA (Australia), Health Canada (Canada), MHRA (UK)
BSL (Biological Safety Level): 1
Spain
HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
End-to-end internal capabilities from cell line development to commercial manufacturing.
MARKETS: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS
COMPLIANCE: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), ISO, INVIMA, Health Canada (Canada GMP), MSPAS, COFEPRIS
REGION: Europe
USE: Human, Veterinary
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
BSL (Biological Safety Level): 1, 2
Spain
53Biologics Production Plant
53Biologics
53Biologics is a Spanish CDMO specialized in decoding the production of biologicals, from DNA to proteins.
MARKETS: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), TGA (Australia), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium, Large
COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO
REGION: Europe
USE: Human, Veterinary
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Quality Assurance services
CATEGORY / PRODUCT: BIOLOGICS
BSL (Biological Safety Level): 1, 2
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: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), TGA (Australia), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium
REGION: Europe
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services
CATEGORY / PRODUCT: BIOLOGICS
BSL (Biological Safety Level): 1
COMPLIANCE: ISO
Spain
Cultiply
Cultiply
Spanish CDMO that develops production and purification processes for recombinant proteins, enzymes, DNA and other bioderived products.
MARKETS: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium
CONTROLLED SUBSTANCES: Lowest potential for abuse
REGION: Europe
SERVICES: Manufacturing services, Development services
CATEGORY / PRODUCT: BIOLOGICS
BSL (Biological Safety Level): 1, 2
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
COMPLIANCE: ISO
Portugal
Rodon Biologics
Rodon Biologics - RDN Serviços de Biotecnologia
Rodon Biologics provides excellence in the development of biopharmaceutical products for third parties.
BATCH SIZE: Small
CATEGORY / PRODUCT: SERVICES, BIOLOGICS, NUTRACEUTICALS
REGION: Europe
SERVICES: Analytical / QC services, Development services
BSL (Biological Safety Level): 1, 2
Spain
HIPRA BIOTECH SERVICES | Aiguaviva
HIPRA Biotech Services
End-to-end internal capabilities from cell line development to commercial manufacturing.
MARKETS: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium, Large
COMPLIANCE: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), ISO, INVIMA, Health Canada (Canada GMP), MSPAS, COFEPRIS
REGION: Europe
USE: Human
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
CATEGORY / PRODUCT: BIOLOGICS
BSL (Biological Safety Level): 1, 2
BATCH SIZE: Medium, Large
THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS
COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), ISO
REGION: Europe
USE: Human
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
BSL (Biological Safety Level): 1, 2
MARKETS: EMA (EU)
BATCH SIZE: Small
THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (G) Genito urinary system and sex hormones, (A) Digestive tract and metabolism
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS
COMPLIANCE: EMA (EU GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), ISO
REGION: Europe
MARKETS: ANVISA (Brazil), CDSCO (India), EMA (EU)
USE: Human
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
BSL (Biological Safety Level): 1, 2
BATCH SIZE: Medium, Large
THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (N) Nervous system
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS
COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), ISO
REGION: Europe
USE: Human
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Packaging, Quality Assurance services
BSL (Biological Safety Level): 1, 2
MARKETS: EMA (EU)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
MARKETS: EDE (UAE), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), Health Canada (Canada), MHRA (UK)
COMPLIANCE: EMA (EU GMP), French Service-Public (CIR), FDA (cGMP), SFDA (Saudi Food & Drug Authority), ISO
REGION: Europe
BSL (Biological Safety Level): 3, 1, 2
USE: Human, Veterinary
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Quality Assurance services
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
MARKETS: EDE (UAE), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), Health Canada (Canada), MHRA (UK)
COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), French Service-Public (CIR), FDA (cGMP), SFDA (Saudi Food & Drug Authority), ISO
BSL (Biological Safety Level): 3, 1, 2
USE: Human, Veterinary
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Quality Assurance services
REGION: North America
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
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