Showing 110 facilities
Germany
Nexora Cell and Tissue Therapy Manufacturing Site
Green Phoenix Labs GmbH
Licensed ATMP site in Germany. GMP manufacturing and QP batch release for cell and tissue therapies.
Services: Development services, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Markets: EMA (EU)
BSL (Biological Safety Level): 1, 2
Use: Human
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
Therapeutic Areas of Expertise (ATC): (S) Sensory organs, (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Batch Size: Small, Medium
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Compliance: EMA (EU GMP)
Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Region: Europe
Spain
HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
End-to-end internal capabilities from cell line development to commercial manufacturing.
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
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)
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)
BSL (Biological Safety Level): 1, 2
Use: Human, Veterinary
Batch Size: Large, Small, Medium
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Region: Europe
Slovenia
JAFRAL
JAFRAL
Integrated biotechnology facility providing R&D, non-GMP and GMP manufacturing, QC testing, and fill & finish services for advanced biologics.
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Compliance: ICH, FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP), SQF (Safe Quality Food)
Markets: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia)
BSL (Biological Safety Level): 1, 2
Category / Product: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Use: Human, Veterinary
Batch Size: Large, Small, Medium
Controlled Substances: Lowest potential for abuse
Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use, (D) Dermatologicals, (V06) Nutrients, (R) Respiratory system, (A) Digestive tract and metabolism
Region: Europe
Switzerland
SENN Chemicals | R&D and Kilo Lab | Dielsdorf, Switzerland
Senn Chemicals
Swiss peptide and peptide intermediates R&D site with SPPS, LPPS, hybrid synthesis, kilo lab scale up, purification and analytics.
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Category / Product: COSMETICS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING
Batch Size: Small
Switzerland
SENN Chemicals | Small Scale GMP Lab | Dielsdorf, Switzerland
Senn Chemicals
Small scale GMP peptide and organic synthesis lab for clinical, niche and high value projects requiring flexible cGMP production.
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Category / Product: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING
Batch Size: Small
Switzerland
SENN Chemicals | GMP Production | Dielsdorf, Switzerland
Senn Chemicals
Swiss cGMP production site for LPPS, SPPS and hybrid peptide manufacturing from pilot to early commercial scale.
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Batch Size: Large, Medium
Category / Product: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING
India
SENN India | Non-GMP Plant | Hyderabad, India
Senn Chemicals
Large scale non GMP manufacturing site for peptide intermediates, organic synthesis, LPPS operations and scale up production.
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: APAC
Batch Size: Large, Small, Medium
Category / Product: COSMETICS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING
India
SENN India | R&D Lab | Hyderabad, India
Senn Chemicals
R&D centre for peptide and organic chemistry with SPPS, purification, lyophilisation, analytics and particle engineering support.
Services: Logistics, Development services, Analytical / QC services, Quality Assurance services, Packaging
Region: APAC
Category / Product: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING
Batch Size: Small
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
China
ProBio CDMO | Biologics Platform
Probio
Global GCT and biologics CDMO, accelerating your pipeline from gene to commercial market.
Region: APAC
Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), EMA (EU GMP)
Batch Size: Large, Small, Medium
Use: Human
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 > 5,000 µg/day)
Italy
Indena Settala
Indena
GMP-compliant and FDA-inspected facility that specializes in complex APIs and high-potent compounds up to OEB 6.
Markets: TGA (Australia), Rest of World, 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)
Batch Size: Small, Medium, Large
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
Compliance: NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Use: Human, Veterinary
Category / Product: CHEMICAL-SYNTHETIC
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