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India
Viswa Laboratories Pvt Ltd
Viswa Laboratories Private Limited
CRAMS/CDMO, API, Productos intermedios y especialidades químicas
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)
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
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
Cina
Pharmaron API Commercial Synthesis Coventry (US)
Pharmaron
Instalación comercial de moléculas peque as (RSM/API)
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
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)
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), 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
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: 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
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.
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)
Spagna
HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
Capacidades internas integrales, desde el desarrollo de líneas celulares hasta la fabricación comercial
COMPLIANCE: ISP (Chile BPM), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA
OEB (Occupational Exposure Banding): 2 (PDE = 1.000 - 5.000 µg/giorno), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 5,000 µg/day)
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
CATEGORIA / PRODOTTO: BIOLOGIA, SERVIZI, FDF / PRODOTTI FARMACEUTICI, CHIMICO-SINTETICO, OLIGONUCLEOTIDI
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
USO: Umano, Veterinario
BSL (Livello di sicurezza biologica): 1, 2
AREE TERAPEUTICHE DI COMPETENZA (ATC): (L) Antineoplastic and immunomodulating agents
Spagna
CZ Vaccines | Large Scale Plant Spain
CZ Vaccines
Instalación Comercial de Escala Comercial de Uso Único
MERCATI: EMA (EU)
SERVIZI: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europe
COMPLIANCE: ISO, EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP)
DIMENSIONE DEL LOTTO: Grande, Medio
CATEGORIA / PRODOTTO: FDF / PRODOTTI FARMACEUTICI, CHIMICO-SINTETICO, OLIGONUCLEOTIDI, BIOLOGIA, INGEGNERIA DELLE PARTICELLE
USO: Umano
BSL (Livello di sicurezza biologica): 1, 2
AREE TERAPEUTICHE DI COMPETENZA (ATC): (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones
Spagna
CZ Vaccines | Investigational and Medicinal Products Plant
CZ Vaccines
Instalación de Ensayos Clínicos
MERCATI: EMA (EU), ANVISA (Brazil), CDSCO (India)
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europe
COMPLIANCE: ISO, ANVISA (Brazil B-GMP), EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP)
CATEGORIA / PRODOTTO: FDF / PRODOTTI FARMACEUTICI, CHIMICO-SINTETICO, BIOLOGIA
USO: Umano
BSL (Livello di sicurezza biologica): 2
AREE TERAPEUTICHE DI COMPETENZA (ATC): (J) Antiinfectives for systemic use, (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
DIMENSIONE DEL LOTTO: Piccolo
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