Directory CDMO|
Directory per la produzione a contratto

MERCATI: EMA (EU), FDA (USA)

SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGIONE: Europe

COMPLIANCE: FDA (cGMP), EMA (GMP UE)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano, Veterinario

BSL (Livello di sicurezza biologica): 1, 2

CATEGORIA / PRODOTTO: BIOLOGIA, SERVICES, FDF / DRUG PRODUCTS

MERCATI: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)

REGIONE: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP)

USO: Umano, Veterinario

CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC

SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

DIMENSIONE DEL LOTTO: Piccolo

AREE TERAPEUTICHE DI COMPETENZA (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

MERCATI: 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), TGA (Australia), Rest of World

SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGIONE: Europe

COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Consiglio di ricerca halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), Servizio pubblico francese (CIR), NMPA (Cina GMP), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP), SQF (alimenti di qualità sicuri), NSF

USO: Umano, Veterinario

BSL (Livello di sicurezza biologica): 1

CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC, SERVICES

DIMENSIONE DEL LOTTO: Piccolo

AREE TERAPEUTICHE DI COMPETENZA (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism

MERCATI: 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), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGIONE: APAC

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano

CATEGORIA / PRODOTTO: OLIGONUCLEOTIDI, CHEMICAL-SYNTHETIC, SERVICES

COMPLIANCE: ANVISA (Brazil B-GMP), NMPA (Cina GMP)

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

SOSTANZE CONTROLLATE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse

MERCATI: 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), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

REGIONE: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), Servizio pubblico francese (CIR), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano

SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

MERCATI: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)

REGIONE: Europe

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), Organizzazione Mondiale della Sanità (GMP / HACCP)

USO: Umano, Veterinario

CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC, SERVICES

SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

DIMENSIONE DEL LOTTO: Piccolo, Medio

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

REGIONE: Europe

COMPLIANCE: ISO, Consiglio di ricerca halal, ECOVADIS

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING

SERVIZI: Development services, Manufacturing services, Analytical / QC services

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

MERCATI: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)

REGIONE: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), Organizzazione Mondiale della Sanità (GMP / HACCP)

USO: Umano, Veterinario

CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC, BIOLOGIA, SERVICES, PARTICLE ENGINEERING

SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services

DIMENSIONE DEL LOTTO: Piccolo, Medio

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

MERCATI: 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)

REGIONE: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP)

USO: Umano, Veterinario

CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC, BIOLOGIA, SERVICES, PARTICLE ENGINEERING

SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

DIMENSIONE DEL LOTTO: Piccolo, Medio

MERCATI: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia)

SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Regulatory services

REGIONE: Europe

COMPLIANCE: ISO

BSL (Livello di sicurezza biologica): 1

DIMENSIONE DEL LOTTO: Piccolo, Medio

CATEGORIA / PRODOTTO: BIOLOGIA

MERCATI: EMA (EU), MHRA (UK), TGA (Australia)

REGIONE: Europe

USO: Umano, Veterinario

BSL (Livello di sicurezza biologica): 1

SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

DIMENSIONE DEL LOTTO: Piccolo, Medio

COMPLIANCE: EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP)

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

MERCATI: 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), TGA (Australia)

REGIONE: APAC

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ECOVADIS, NMPA (Cina GMP), EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano, Veterinario

CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC

SERVIZI: Development services, Manufacturing services, Analytical / QC services, Regulatory services, Packaging