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Laboratorio REIG JOFRE, SA (TOLEDO PLANT)
LABORATORIO REIG JOFRE SA
Installations de développement et de fabrication de bêtalactamines (FDF) à la pointe de la technologie.
MARCHÉS: DIGEMID (Peru), ANVISA (Brazil), ISP (Chile), Russian Health Authorities, EMA (EU), SFDA (Saudi Arabia), TGA (Australia), INVIMA (Colombia), MHRA (UK)
TAILLE DU LOT: Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX
COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE), DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), TGA (Australia GMP), SFDA (Saudi Food & Drug Authority), ECOVADIS, INVIMA, Santé Canada (Canada GMP)
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse
RÉGION: Europe, Asie-Pacifique, LATAM, Amérique du Nord, MENA
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
BSL (niveau de sécurité biologique): 1
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (J) Antiinfectives for systemic use

Laboratorios Grifols | Barcelona Plant
Grifols International
Solutions de fabrication stériles (petites molécules) en poches souples et flacons.
MARCHÉS: ANMAT (Argentina), ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada), MHRA (UK)
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX
COMPLIANCE: ISP (Chile BPM), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, INVIMA, Santé Canada (Canada GMP), MFDS/KFDA (République de Corée GMP)
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
RÉGION: Europe
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
LABORATORIO REIG JOFRE SA
Installations de fabrication de produits injectables (lyo et liquides) et liquides.
TAILLE DU LOT: Moyen, Grandes dimensions
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system
CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX
COMPLIANCE: ISP (Chile BPM), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), ECOVADIS, INVIMA, Santé Canada (Canada GMP), MFDS/KFDA (République de Corée GMP)
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
RÉGION: Europe
BSL (niveau de sécurité biologique): 3, 1, 2
MARCHÉS: ANVISA (Brazil), ISP (Chile), PMDA (Japan), EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)

HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
Capacités internes de bout en bout, du développement de lignées cellulaires à la fabrication commerciale.
MARCHÉS: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX, BIOLOGIE
COMPLIANCE: ISP (Chile BPM), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), FDA (cGMP), ISO, INVIMA, Santé Canada (Canada GMP), MSPAS, COFEPRIS
RÉGION: Europe
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
BSL (niveau de sécurité biologique): 1, 2

Laboratorios Grifols | Murcia Plant
Grifols International
Solutions de fabrication stériles (petites molécules) en sacs souples.
MARCHÉS: ANMAT (Argentina), ANVISA (Brazil), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia)
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX
COMPLIANCE: ISP (Chile BPM), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, INVIMA, Santé Canada (Canada GMP), MFDS/KFDA (République de Corée GMP)
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
RÉGION: Europe
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (M) Musculoskeletal system, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system

HIPRA BIOTECH SERVICES | Aiguaviva
HIPRA Biotech Services
Capacités internes de bout en bout, du développement de lignées cellulaires à la fabrication commerciale.
MARCHÉS: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
COMPLIANCE: ISP (Chile BPM), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), FDA (cGMP), ISO, INVIMA, Santé Canada (Canada GMP), MSPAS, COFEPRIS
RÉGION: Europe
USAGE: Humain
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
CATÉGORIE / PRODUIT: BIOLOGIE
BSL (niveau de sécurité biologique): 1, 2

MARCHÉS: DIGEMID (Peru), ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system
CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX
COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), Service public français (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (BPF de Chine), ECOVADIS, ISO, INVIMA, Santé Canada (Canada GMP), MSPAS, MFDS/KFDA (République de Corée GMP), COFEPRIS
RÉGION: Europe
USAGE: Humain
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 10,000 µg/day)

CARBOGEN AMCIS | Veenendaal
CARBOGEN AMCIS
Fabrication à grande échelle d’analogues du cholestérol et de la vitamine D.
MARCHÉS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest of World, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
TAILLE DU LOT: Petit
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (V04) Diagnostic agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (B) Blood and blood forming organs, (V06) Nutrients
COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), Service public français (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (BPF de Chine), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Conseil de recherche sur le halal, INVIMA, Santé Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (République de Corée GMP), COFEPRIS
CATÉGORIE / PRODUIT: SERVICES, CHIMIQUE-SYNTHÉTIQUE
RÉGION: Europe
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
BSL (niveau de sécurité biologique): 1

Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site
Seacross Pharmaceutical Co Ltd
En tant que l'un des trois sites principaux, aux côtés du centre de R&D et de l'usine de formulation, notre usine de fabrication d'API joue un rôle essentiel da
MARCHÉS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest of World, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (V04) Diagnostic agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (B) Blood and blood forming organs, (V06) Nutrients
COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), Service public français (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (BPF de Chine), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Conseil de recherche sur le halal, INVIMA, Santé Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (République de Corée GMP), COFEPRIS
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
BSL (niveau de sécurité biologique): 3, 4, 1, 2
USAGE: Humain
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
RÉGION: Asie-Pacifique
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
CATÉGORIE / PRODUIT: CHIMIQUE-SYNTHÉTIQUE

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
Seacross Pharmaceutical Co Ltd
Le centre de R&D joue un rôle fondamental en soutenant le développement d’API et de formes posologiques finies.
MARCHÉS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest of World, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (V04) Diagnostic agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (B) Blood and blood forming organs, (V06) Nutrients
CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX, CHIMIQUE-SYNTHÉTIQUE
COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), Service public français (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (BPF de Chine), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Conseil de recherche sur le halal, INVIMA, Santé Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (République de Corée GMP), COFEPRIS
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
BSL (niveau de sécurité biologique): 3, 4, 1, 2
USAGE: Humain
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
RÉGION: Asie-Pacifique
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)

Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site
Seacross Pharmaceutical Co Ltd
Le site de fabrication de formulations est dédié au développement et à la production de formes galéniques complexes et de grande valeur.
MARCHÉS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest of World, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (V04) Diagnostic agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (B) Blood and blood forming organs, (V06) Nutrients
CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX, SERVICES
COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), Service public français (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (BPF de Chine), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Conseil de recherche sur le halal, INVIMA, Santé Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (République de Corée GMP), COFEPRIS
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
BSL (niveau de sécurité biologique): 3, 4, 1, 2
USAGE: Humain
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
RÉGION: Asie-Pacifique
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
FDF / PRODUITS MÉDICAMENTEUX manufacturing site
MAI network supplier
Nous soutenons le développement de médicaments avec des services de fabrication en petits lots à toutes les étapes du processus de développement de médicaments.
Location available after registration
