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Belgio

White Raven - Legiapark

White Raven

Sitio de fill & finish dedicado a la formulación GMP y al llenado aséptico de inyectables líquidos estériles.

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MERCATI: EMA (EU)

REGIONE: Europe

CATEGORIA / PRODOTTO: FDF / PRODOTTI FARMACEUTICI, CHIMICO-SINTETICO, SERVIZI

USO: Umano

BSL (Livello di sicurezza biologica): 1, 2

SERVIZI: Manufacturing services, Packaging

DIMENSIONE DEL LOTTO: Piccolo, Medio

COMPLIANCE: EMA (GMP UE)

India

Viswa Laboratories Pvt Ltd

Viswa Laboratories Private Limited

CRAMS/CDMO, API, Productos intermedios y especialidades químicas

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MERCATI: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, CDSCO (India)

REGIONE: APAC, Europe

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: CHIMICO-SINTETICO, SERVIZI

USO: Umano, Veterinario

BSL (Livello di sicurezza biologica): 2

SERVIZI: Development services, Manufacturing services, Regulatory services

AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (R) Respiratory system

SOSTANZE CONTROLLATE: Lower potential for abuse

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1.000 µg/giorno)

COMPLIANCE: Organizzazione Mondiale della Sanità (GMP / HACCP)

Spagna

Sylentis

Fabricante de oligonucleótidos

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COMPLIANCE: ICH, FDA (cGMP), ISO, EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP)

MERCATI: EMA (EU), FDA (USA)

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

REGIONE: Europe

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: CHIMICO-SINTETICO, OLIGONUCLEOTIDI, SERVIZI

USO: Umano, Veterinario

AREE TERAPEUTICHE DI COMPETENZA (ATC): (L) Antineoplastic and immunomodulating agents

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1.000 - 5.000 µg/giorno), 3 (PDE = 100 - 1.000 µg/giorno)

Portorico

Sidefarma

Sidefarma SA

Sidefarma es un CMO especializado en la fabricación de lotes peque os y medianos para compa ías farmacéuticas de todo el mundo, en mercados regulados y siguiend

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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), Health Canada (Canada), DIGEMID (Peru), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), TGA (Australia)

REGIONE: Europe

COMPLIANCE: ISO, UAE Ministry of Health & Prevention, EMA (GMP UE)

CATEGORIA / PRODOTTO: FDF / PRODOTTI FARMACEUTICI, CHIMICO-SINTETICO, SERVIZI

USO: Umano

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

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1.000 - 5.000 µg/giorno), 3 (PDE = 100 - 1.000 µg/giorno)

DIMENSIONE DEL LOTTO: Piccolo, Medio

Portorico

Rodon Biologics

Rodon Biologics - RDN Serviços de Biotecnologia

Rodon Biologics ofrece excelencia en el desarrollo de productos biofarmacéuticos para terceros.

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REGIONE: Europe

CATEGORIA / PRODOTTO: FDF / PRODOTTI FARMACEUTICI, CHIMICO-SINTETICO, NUTRACEUTICI, OLIGONUCLEOTIDI, BIOLOGIA, SERVIZI

USO: Umano

BSL (Livello di sicurezza biologica): 1, 2

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

AREE TERAPEUTICHE DI COMPETENZA (ATC): (L) Antineoplastic and immunomodulating agents

DIMENSIONE DEL LOTTO: Piccolo

Spagna

Rioja Nature Pharma

Rioja Nature Pharma SL

CDMO NUTRACÉUTICOS/COMPLEMENTOS ALIMENTICIOS

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MERCATI: EMA (EU), NMPA (China), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)

REGIONE: Europe

COMPLIANCE: FDA (cGMP), IFS, Consiglio di ricerca halal, UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP), NSF

CATEGORIA / PRODOTTO: FDF / PRODOTTI FARMACEUTICI, CHIMICO-SINTETICO, NUTRACEUTICI, SERVIZI

USO: Umano, Veterinario

SERVIZI: Development services, Manufacturing services

AREE TERAPEUTICHE DI COMPETENZA (ATC): (V06) Nutrients

DIMENSIONE DEL LOTTO: Medio

Cina

Pharmaron API Commercial Synthesis Coventry (US)

Pharmaron

Instalación comercial de moléculas peque as (RSM/API)

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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, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

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), MHRA (UK), MFDS (South Korea), TGA (Australia)

SERVIZI: Logistics, Development services, Manufacturing services

COMPLIANCE: FDA (cGMP), ISO, ECOVADIS

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: CHIMICO-SINTETICO, SERVIZI

USO: Umano, Veterinario

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1.000 - 5.000 µg/giorno), 3 (PDE = 100 - 1.000 µg/giorno)

REGIONE: North America

Cina

Pharmaron API Commercial Synthesis Shaoxing (China)

Pharmaron

Instalación comercial de moléculas peque as (RSM/API) / péptidos

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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), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1.000 - 5.000 µg/giorno), 3 (PDE = 100 - 1.000 µg/giorno)

MERCATI: NMPA (China), FDA (USA)

REGIONE: APAC

COMPLIANCE: FDA (cGMP), ISO, NMPA (Cina GMP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: CHIMICO-SINTETICO, INGEGNERIA DELLE PARTICELLE

USO: Umano, Veterinario

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

Cina

Pharmaron API Commercial Synthesis Cramlington (UK)

Pharmaron

Instalación comercial de moléculas peque as (RSM/API)

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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), MHRA (UK), MFDS (South Korea), TGA (Australia)

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

REGIONE: Europe

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), EMA (GMP UE), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: CHIMICO-SINTETICO

USO: Umano, Veterinario

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1.000 - 5.000 µg/giorno), 3 (PDE = 100 - 1.000 µg/giorno)

Italia

Indena Settala

Indena

Nuestra instalación totalmente conforme con GMP y aprobada por la FDA, ubicada en Settala (a 20 minutos de Milán), está especializada en APIs complejos y compue

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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)

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), NMPA (Cina GMP), EMA (GMP UE), MFDS/KFDA (Repubblica di Corea GMP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: CHIMICO-SINTETICO, SERVIZI

USO: Umano, Veterinario

India

Hikal Ltd | Bangalore, India

Hikal Ltd.

Desarrollo de procesos cGMP, escalado y fabricación de APIs de moléculas pequeñas, nuevas entidades moleculares (NMEs) e intermedios, desde gramos hasta kilogra

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COMPLIANCE: ANVISA (Brazil B-GMP), COFEPRIS, Consiglio di ricerca halal, ECOVADIS, TGA (Australia GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), EMA (GMP UE)

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 5 / HPAPI (PDE < 10 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1.000 - 5.000 µg/giorno), 3 (PDE = 100 - 1.000 µg/giorno)

MERCATI: ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), TGA (Australia)

REGIONE: APAC

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: CHIMICO-SINTETICO, COSMETICI, NUTRACEUTICI, SERVIZI

USO: Umano, Veterinario

SERVIZI: Development services, Manufacturing services, Regulatory services

AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (V06) Nutrients

Spagna

HIPRA BIOTECH SERVICES | Aiguaviva

HIPRA Biotech Services

Capacidades internas de principio a fin, desde el desarrollo de líneas celulares hasta la fabricación comercial.

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MERCATI: 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)

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

REGIONE: Europe

COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: CHIMICO-SINTETICO, OLIGONUCLEOTIDI, BIOLOGIA, SERVIZI

USO: Umano, Veterinario

BSL (Livello di sicurezza biologica): 1, 2

AREE TERAPEUTICHE DI COMPETENZA (ATC): (L) Antineoplastic and immunomodulating agents

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1.000 - 5.000 µg/giorno), 3 (PDE = 100 - 1.000 µg/giorno)

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