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CARBOGEN AMCIS | Bubendorf
CARBOGEN AMCIS
Development and cGMPmanufacturing of Highly Potent API including Antibody Drug Conjugates (ADC).
SERVICES: Development services, Analytical / QC services, Regulatory services, Quality Assurance services, Manufacturing services
MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)
USE: Human, Veterinary
THERAPEUTIC AREAS OF EXPERTISE (ATC): (V09-10) Radiopharmaceuticals, (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (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 > 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)
CATEGORY / PRODUCT: PARTICLE ENGINEERING, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
REGION: Europe
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 > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS
REGION: Europe
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
Bilthoven Biologicals Drug Substance and Drug Product Facilities
Bilthoven Biologicals BV
Multi-product GMP facilities for Drug Substance and Drug Product.
SERVICES: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
MARKETS: EMA (EU), MHRA (UK)
BSL (Biological Safety Level): 1, 2
USE: Human
BATCH SIZE: Large, Small, Medium
COMPLIANCE: EMA (EU GMP)
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
REGION: Europe
HBM Pharma
Hbm Pharma
EU-GMP-certified CMO based in Martin, Slovakia. The company provides manufacturing and packaging servicesfor sterile pharm. products and solid oral dosage forms
MARKETS: EMA (EU), NMPA (China), Health Canada (Canada), ANVISA (Brazil), COFEPRIS (Mexico), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, TGA (Australia)
COMPLIANCE: ISO, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), ANVISA (Brazil)
USE: Human
BATCH SIZE: Large, Small, Medium
SERVICES: Analytical / QC services, Packaging, Quality Assurance services, Manufacturing services
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)
CONTROLLED SUBSTANCES: High potential for abuse & medical use
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES
REGION: Europe
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
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
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
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
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
Laboratorio REIG JOFRE, SA (TOLEDO PLANT)
LABORATORIO REIG JOFRE SA
Betalactam antibiotics (FDF) development and manufacturing state-of-the-art facilities.
MARKETS: EMA (EU), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), INVIMA (Colombia), SFDA (Saudi Arabia), TGA (Australia)
REGION: APAC, MENA, LATAM, Europe, North America
COMPLIANCE: DIGEMID, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
BATCH SIZE: Large, Medium
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): (J) Antiinfectives for systemic use
CONTROLLED SUBSTANCES: Lowest potential for abuse
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS
Laboratorios Grifols | Barcelona Plant
Grifols International
Sterile manufacturing solutions (small molecules) in flexible bags and vials.
MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), 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)
BATCH SIZE: Large, Small, Medium
USE: Human, Veterinary
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism
CONTROLLED SUBSTANCES: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
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: FDF / DRUG PRODUCTS
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