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Spain
VIVEbiotech
VIVEbiotech
Your leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors.
BATCH SIZE: Small, Medium, Large
COMPLIANCE: EMA (EU GMP), MHRA (UK GMP), French Service-Public (CIR), FDA (cGMP)
REGION: Europe
USE: Human
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
MARKETS: FDA (USA), EMA (EU), MHRA (UK)
CATEGORY / PRODUCT: BIOLOGICS
BSL (Biological Safety Level): 1, 2
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
Netherlands
Bilthoven Biologicals Drug Substance and Drug Product Facilities
Bilthoven Biologicals
Multi-product GMP facilities for Drug Substance and Drug Product.
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
COMPLIANCE: EMA (EU GMP)
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), MHRA (UK)
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
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.
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
THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (B) Blood and blood forming organs
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, COSMETICS, SERVICES, BIOLOGICS
COMPLIANCE: EMA (EU GMP), ISO
REGION: Europe
USE: Human, Veterinary
SERVICES: Analytical / QC services, Manufacturing services, Development services, Quality Assurance 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)
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Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
EU-GMP-certified CMO based in Martin, Slovakia. The company provides manufacturing and packaging servicesfor sterile pharm. products and solid oral dosage forms
Location available after registration
Limited view
CDMO/CMO facility
MAI network supplier
B2B peptide R&D and OEM/ODM services for cosmetic brands and manufacturers.
Location available after registration
Limited view
CDMO/CMO facility
MAI network supplier
B2B peptide R&D and OEM/ODM services for cosmetic brands and manufacturers.
Location available after registration
Spain
Laboratorio REIG JOFRE, SA (TOLEDO PLANT)
LABORATORIO REIG JOFRE SA
Betalactam antibiotics (FDF) development and manufacturing state-of-the-art facilities.
MARKETS: DIGEMID (Peru), ANVISA (Brazil), ISP (Chile), Russian Health Authorities, EMA (EU), SFDA (Saudi Arabia), TGA (Australia), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Medium, Large
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), EMA (EU GMP), DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), TGA (Australia GMP), SFDA (Saudi Food & Drug Authority), ECOVADIS, INVIMA, Health Canada (Canada GMP)
CONTROLLED SUBSTANCES: Lowest potential for abuse
REGION: Europe, APAC, LATAM, North America, MENA
USE: Human, Veterinary
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), 1 / low-hazard (PDE > 10,000 µg/day)
BSL (Biological Safety Level): 1
THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use
Limited view
CDMO/CMO facility
MAI network supplier
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Location available after registration
Limited view
COSMETICS manufacturing site
MAI network supplier
Large scale non GMP manufacturing site for peptide intermediates, organic synthesis, LPPS operations and scale up production.
Location available after registration