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Laboratorios Grifols | Barcelona Plant
Espagne

Laboratorios Grifols | Barcelona Plant

Grifols International

Solutions de fabrication stériles (petites molécules) en poches souples et flacons.

MARCHÉS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)

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

RÉGION: Europe

COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain, Vétérinaire

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism

SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)

CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
Espagne

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)

LABORATORIO REIG JOFRE SA

Installations de fabrication de produits injectables (lyo et liquides) et liquides.

BSL (niveau de sécurité biologique): 3, 1, 2

MARCHÉS: EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MHRA (UK), INVIMA (Colombia), MFDS (South Korea), TGA (Australia)

RÉGION: Europe

TAILLE DU LOT: Grandes dimensions, Moyen

USAGE: Humain, Vétérinaire

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

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism

SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

COMPLIANCE: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ECOVADIS, INVIMA, ISP (Chile BPM), EMA (BPF DE L'UE), Santé Canada (Canada GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP)

OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)

CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX

Pharmaron API Commercial Synthesis Cramlington (UK)
Royaume-Uni

Pharmaron API Commercial Synthesis Cramlington (UK)

Pharmaron

Synthèse de petites molécules API commerciales.

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (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

SUBSTANCES CONTRÔLÉES: 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

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

RÉGION: Europe

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain, Vétérinaire

CATÉGORIE / PRODUIT: CHIMIQUE-SYNTHÉTIQUE

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

OEB (bandes d´exposition professionnelle): 4 / HPAPI (PDE = 10 - 100 µg/jour), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)

Lifecore Injectables CDMO
États-Unis

Lifecore Injectables CDMO

Lifecore Biomedical

CDMO qui fabrique des produits pharmaceutiques injectables stériles cliniques et commerciaux.

BSL (niveau de sécurité biologique): 3, 1, 2

MARCHÉS: 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

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

COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP), MFDS/KFDA (République de Corée GMP)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain, Vétérinaire

SUBSTANCES CONTRÔLÉES: Lowest potential for abuse

OEB (bandes d´exposition professionnelle): 4 / HPAPI (PDE = 10 - 100 µg/jour), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)

RÉGION: Amérique du Nord

CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX

Laboratorios Grifols | Murcia Plant
Espagne

Laboratorios Grifols | Murcia Plant

Grifols International

Solutions de fabrication stériles (petites molécules) en sacs souples.

MARCHÉS: EMA (EU), FDA (USA), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)

SERVICES: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging

RÉGION: Europe

COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain, Vétérinaire

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism

SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)

CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX

EVER Pharma Jena GmbH
Allemagne

EVER Pharma Jena GmbH

EVER Neuro Pharma GmbH

CDMO spécialisé dans le développement et la production de petites molécules injectables.

OEB (bandes d´exposition professionnelle): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)

SUBSTANCES CONTRÔLÉES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MARCHÉS: 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

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

RÉGION: Europe

COMPLIANCE: ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), NMPA (BPF de Chine), EMA (BPF DE L'UE), MFDS/KFDA (République de Corée GMP)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain

BSL (niveau de sécurité biologique): 1, 2

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system

CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX

Avara Pharmaceutical Services | Arecibo Site
États-Unis

Avara Pharmaceutical Services | Arecibo Site

AVARA

Installation de fabrication de doses solides orales (OSD) à l'échelle commerciale avec une forte expertise dans les substances contrôlées (DEA II V).

SUBSTANCES CONTRÔLÉES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

COMPLIANCE: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP), MFDS/KFDA (République de Corée GMP)

MARCHÉS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), TGA (Australia)

TAILLE DU LOT: Grandes dimensions, Moyen

USAGE: Humain

CATÉGORIE / PRODUIT: CHIMIQUE-SYNTHÉTIQUE, SERVICES, FDF / PRODUITS MÉDICAMENTEUX, INGÉNIERIE DES PARTICULES

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

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (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, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

RÉGION: Amérique du Nord

OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)

Avara Pharmaceutical Services | Norman Site
États-Unis

Avara Pharmaceutical Services | Norman Site

AVARA

Installation de fabrication sous contrat spécialisée dans le dosage oral solide (OSD) pour l'approvisionnement clinique et commercial.

SUBSTANCES CONTRÔLÉES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

COMPLIANCE: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP)

MARCHÉS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea), TGA (Australia)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain

CATÉGORIE / PRODUIT: CHIMIQUE-SYNTHÉTIQUE, SERVICES, FDF / PRODUITS MÉDICAMENTEUX, INGÉNIERIE DES PARTICULES

SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (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, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

RÉGION: Amérique du Nord

OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)

Indena Settala
Italie

Indena Settala

Indena

Installation conforme aux BPF et inspectée par la FDA, spécialisée dans les API complexes et les composés très puissants jusqu'à OEB 6.

MARCHÉS: 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)

TAILLE DU LOT: Petit, Moyen, Grandes dimensions

OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour)

COMPLIANCE: NMPA (BPF de Chine), EMA (BPF DE L'UE), MFDS/KFDA (République de Corée GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP)

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

RÉGION: Europe

USAGE: Humain, Vétérinaire

CATÉGORIE / PRODUIT: CHIMIQUE-SYNTHÉTIQUE

FAES FARMA | DERIO facility
Espagne

FAES FARMA | DERIO facility

FAES FARMA

Développeur et fabricant de médicaments à usage humain.

MARCHÉS: 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), MFDS (South Korea), EDE (UAE), TGA (Australia)

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

RÉGION: Europe

COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), Service public français (CIR), NMPA (BPF de Chine), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX

OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 10,000 µg/day)

CARBOGEN AMCIS | Veenendaal
Pays-Bas

CARBOGEN AMCIS | Veenendaal

CARBOGEN AMCIS

Fabrication à grande échelle d’analogues du cholestérol et de la vitamine D.

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (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 (bandes d´exposition professionnelle): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)

MARCHÉS: 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

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

RÉGION: Europe

COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Conseil de recherche sur le halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), Service public français (CIR), NMPA (BPF de Chine), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP), SQF (Safe Quality Food), NSF

USAGE: Humain, Vétérinaire

BSL (niveau de sécurité biologique): 1

CATÉGORIE / PRODUIT: CHIMIQUE-SYNTHÉTIQUE, SERVICES

TAILLE DU LOT: Petit

CARBOGEN AMCIS | Saint-Beauzire
France

CARBOGEN AMCIS | Saint-Beauzire

CARBOGEN AMCIS

Développement de formulations personnalisées et fabrication stérile GMP de produits médicamenteux liquides et lyophilisés.

OEB (bandes d´exposition professionnelle): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)

SUBSTANCES CONTRÔLÉES: 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

MARCHÉS: 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

RÉGION: 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), Service public français (CIR), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain

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

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (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

CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX

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