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SOSTANZE CONTROLLATE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MERCATI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)
REGIONE: Europe
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (A) Digestive tract and metabolism
COMPLIANCE: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (GMP UE), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea 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)
CATEGORIA / PRODOTTO: SERVICES, FDF / DRUG PRODUCTS
Lituania
Northway Biotech Vilnius
Northway Biotech
CDMO globale di servizi integrali in ambito biologico
BSL (Livello di sicurezza biologica): 3, 1, 2
MERCATI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ISO, SFDA (Saudi Food & Drug Authority), Servizio pubblico francese (CIR), EMA (GMP UE)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano, Veterinario
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
CATEGORIA / PRODOTTO: BIOLOGIA, SERVICES, FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
Germania
Adragos Pharma | Leipzig
Adragos Pharma
Prodotti farmaceutici semisolidi e liquidi non sterili.
SOSTANZE CONTROLLATE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MERCATI: EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), MFDS (South Korea)
SERVIZI: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europe
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano, Veterinario
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)
COMPLIANCE: EMA (GMP UE)
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
Norvegia
Adragos Pharma | Halden
Adragos Pharma
Siamo specializzati nella produzione di sacche per flebo, fiale e fiale di plastica utilizzando la tecnologia Blow-Fill-Seal (BFS) e altre forme di dosaggio.
SOSTANZE CONTROLLATE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MERCATI: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), TGA (Australia)
SERVIZI: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, NMPA (Cina GMP), EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP), NSF
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano
AREE TERAPEUTICHE DI COMPETENZA (ATC): (D) Dermatologicals, (V06) Nutrients, (A) Digestive tract and metabolism
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)
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
Grecia
Adragos Pharma | Athens
Adragos Pharma
È specializzato nello sviluppo di farmaci a valore aggiunto ed è stato recentemente aggiornato con funzionalità HPAPI.
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, Lower potential for abuse
MERCATI: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), UAE Ministry of Health & Prevention, NMPA (Cina GMP), EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP), NSF
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano
CATEGORIA / PRODOTTO: SERVICES, FDF / DRUG PRODUCTS
Svizzera
Adragos Pharma | Jura
Adragos Pharma
Siamo specializzati nella produzione asettica di prodotti farmaceutici (bio)farmaceutici sterili liofilizzati o liquidi attraverso il riempimento e la finitura.
MERCATI: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), MHRA (UK), MFDS (South Korea)
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europe
COMPLIANCE: FDA (cGMP), EMA (GMP UE)
USO: Umano
SOSTANZE CONTROLLATE: High potential for abuse & no medical use
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)
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
Germania
Glatt Pharmaceutical Services GmbH Co. & KG
Glatt Pharmaceutical Services GmbH Co. & KG
Il vostro CDMO conforme a cGMP per servizi end-to-end nel campo delle forme di dosaggio complesse dei solidi orali, con sede a Binzen in Germania.
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), FDA (USA)
REGIONE: Europe
COMPLIANCE: FDA (cGMP), EMA (GMP UE)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano, Veterinario
BSL (Livello di sicurezza biologica): 1
SERVIZI: Development services, Manufacturing services, Analytical / QC services
AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (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, (R) Respiratory system, (S) Sensory organs, (V06) Nutrients, (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)
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
Italia
Adare Pharma | EU
Adare Pharma Solutions
CDMO globale offre sviluppo di prodotti chiavi in mano attraverso competenze di produzione commerciale, focalizzate su forme di dosaggio orali.
AREE TERAPEUTICHE DI COMPETENZA (ATC): (A) Digestive tract and metabolism, (C) Cardiovascular system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V01) Allergens
MERCATI: TGA (Australia), 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)
COMPLIANCE: Servizio pubblico francese (CIR), NMPA (Cina GMP), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Consiglio di ricerca halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
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), 4 / HPAPI (PDE = 10 - 100 µg/giorno)
CATEGORIA / PRODOTTO: SERVICES, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europe
USO: Umano, Veterinario
Germania
Green Phoenix Labs GmbH
Green Phoenix Labs GmbH
Azienda di terapia cellulare con capacità di camere bianche in eccesso.
AREE TERAPEUTICHE DI COMPETENZA (ATC): (R) Respiratory system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system
SOSTANZE CONTROLLATE: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
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)
COMPLIANCE: EMA (GMP UE)
CATEGORIA / PRODOTTO: BIOLOGIA, SERVICES, FDF / DRUG PRODUCTS
MERCATI: EMA (EU)
SERVIZI: Logistics, Development services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europe
USO: Umano
BSL (Livello di sicurezza biologica): 1
Regno Unito
Seda Pharma Development Services
Seda Pharma Development Services Ltd
Seda Pharmaceutical Development Services è specializzata nello sviluppo farmaceutico integrato e nella farmacologia clinica.
AREE TERAPEUTICHE DI COMPETENZA (ATC): (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system, (B) Blood and blood forming organs
MERCATI: 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)
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), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno)
COMPLIANCE: MHRA (UK GMP), ECOVADIS
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
REGIONE: Europe
USO: Umano
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Spagna
PHARMALOOP S.L. - a Salvat Company
Laboratorios Salvat
Soluzioni CDMO completamente integrate per Blow-Fill-Seal (BFS), multidose sterile, multidose non sterile, bustine, capsule e compresse.
MERCATI: EMA (EU), FDA (USA)
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ISO, EMA (GMP UE)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano
BSL (Livello di sicurezza biologica): 1
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
AREE TERAPEUTICHE DI COMPETENZA (ATC): (S) Sensory organs, (V01) Allergens
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
Svizzera
Ophtapharm, a Sentiss Company
Ophtapharm, a Sentiss Company
Oftalmico e ottico - Soluzioni, sospensioni, emulsioni, unguenti e gel - Struttura approvata dalla FDA.
MERCATI: EMA (EU), FDA (USA)
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ISO, EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano, Veterinario
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS