
Adare Pharma Solutions
Globalne CDMO oferujące rozwój produktów „pod klucz” w oparciu o specjalistyczną wiedzę dotyczącą produkcji komercyjnej, skupiającą się na doustnych postaciach
Services: Development services, Logistics, Analytical / QC services, Packaging, 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), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), TGA (Australia)
Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, French Service-Public (CIR), NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
Use: Human, Veterinary
Batch Size: Large, Small, Medium
Therapeutic Areas of Expertise (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (V01) Allergens, (R) Respiratory system, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING, ANALITYCZNE CRO
Region: Europe

Adare Pharma Solutions
Adare Pharma jest globalną instalacją CDMO w EE.UU. y la UE, que ofrece desarrollo deproductos llave en mano mediante experiencia en Fabricación comerci
Services: Development services, Logistics, Analytical / QC services, Packaging, 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), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), TGA (Australia)
Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, French Service-Public (CIR), NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
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), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING, ANALITYCZNE CRO
Therapeutic Areas of Expertise (ATC): (C) Cardiovascular system, (A) Digestive tract and metabolism
Region: North America

Aenova
Centrum Kompetencyjne w zakresie suszenia rozpyłowego i peletek o zmodyfikowanym uwalnianiu.
Markets: EMA (EU), PMDA (Japan), SFDA (Saudi Arabia), MFDS (South Korea)
Region: Europe
Compliance: ISO, PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
Batch Size: Large, Small, Medium
Category / Product: NUTRACEUTICALS, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
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)

Laboratorios Salvat
W pełni zintegrowane rozwiązania CDMO do opakowań typu Blow-Fill-Seal (BFS), sterylnych wielodawkowych, niesterylnych wielodawkowych, saszetek, kapsułek i table
Markets: EMA (EU), FDA (USA)
Region: Europe
Compliance: FDA (cGMP), ISO, EMA (EU GMP)
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (S) Sensory organs, (V01) Allergens
Category / Product: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
MAI network supplier
Twój zaufany CDMO GMP w zakresie zaawansowanej aseptycznej i nieaseptycznej produkcji leków farmaceutycznych, opracowywania receptur i testów analitycznych.
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Polpharma API
Integrated CDMO solutions for HP APIs (OEB 6), ADC payload-linkers and oligonucleotides from development to GMP supply.
Compliance: BRCGS, ISO, ICH, FDA (cGMP), DIGEMID, ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, PMDA/MHLW (Japan GMP), TGA (Australia GMP), INVIMA, ECOVADIS, ISP (Chile BPM), TITCK (Turkish Health Authorities), French Service-Public (CIR), ANMAT (Argentina nueva GMP), EMA (EU GMP), NMPA (China GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP), SQF (Safe Quality Food), NSF, UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), NMPA (China GMP), PMDA (Japan), ANVISA (Brazil), Health Canada, MHRA (UK), TGA (Australia)
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), MHRA (UK), MFDS (South Korea)
Batch Size: Large, Small, Medium
Services: Development services, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services
Therapeutic Areas of Expertise (ATC): (N) Nervous system, (B) Blood and blood forming organs, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Category / Product: PARTICLE ENGINEERING, SERVICES, CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES
Use: Human
OEB (Occupational Exposure Banding): 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), 2 (PDE = 1,000 - 5,000 µg/day)
Region: Europe

CARBOGEN AMCIS
Rozwój i produkcja cGMP na średnią skalę, w tym chromatografia.
Use: Human, Veterinary
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), CDSCO (India), MFDS (South Korea), TGA (Australia)
Services: Development services, Analytical / QC services, Manufacturing services, Quality Assurance services
Compliance: ISO, FDA (cGMP), PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP)
Batch Size: Small, Medium
Category / Product: ANALITYCZNE CRO, PARTICLE ENGINEERING, BIOLOGICS, CHEMICAL-SYNTHETIC
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Region: Europe

CARBOGEN AMCIS
Odkryj nasze możliwości w zakresie produkcji składników kosmetycznych, wysokowartościowych chemikaliów i możliwości niestandardowej syntezy półproduktów farmace
Batch Size: Large, Small, Medium
Services: Development services, Analytical / QC services, Manufacturing services
Compliance: ISO, Halal Research Council, ECOVADIS
Category / Product: ANALITYCZNE CRO, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Region: Europe

CARBOGEN AMCIS
Rozwój i produkcja cGMP wysoce silnego API, w tym koniugatów przeciwciał i leków (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 > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: PARTICLE ENGINEERING, ANALITYCZNE CRO, BIOLOGICS, CHEMICAL-SYNTHETIC
Region: Europe

Senn Chemicals
Szwajcarski ośrodek badawczo-rozwojowy dotyczący peptydów i półproduktów peptydowych obejmujący SPPS, LPPS, syntezę hybrydową, zwiększanie skali laboratoryjnej
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Category / Product: COSMETICS, CHEMICAL-SYNTHETIC, ANALITYCZNE CRO, PARTICLE ENGINEERING
Batch Size: Small

Senn Chemicals
Laboratorium peptydów GMP i syntezy organicznej na małą skalę do projektów klinicznych, niszowych i o wysokiej wartości, wymagających elastycznej produkcji cGMP
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
Szwajcarski zakład produkcyjny cGMP do produkcji LPPS, SPPS i peptydów hybrydowych od pilotażu do wczesnej skali komercyjnej.
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
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