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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).

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TAILLE DU LOT: Moyen, Grandes dimensions

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC

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

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

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

USAGE: Humain

SERVICES: Analytical / QC services, 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)

RÉGION: North America

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.

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TAILLE DU LOT: Petit, Moyen, Grandes dimensions

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC

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

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

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

USAGE: Humain

SERVICES: Analytical / QC services, Manufacturing 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)

RÉGION: North America

Royaume-Uni

CARBOGEN AMCIS | Manchester, UK

CARBOGEN AMCIS

Découvrez nos capacités de fabrication d'ingrédients cosmétiques, de chimie fine et de synthèse personnalisée d'intermédiaires pharmaceutiques.

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TAILLE DU LOT: Petit, Moyen, Grandes dimensions

CATÉGORIE / PRODUIT: SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC

RÉGION: Europe

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

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

COMPLIANCE: ECOVADIS, ISO, Conseil de recherche sur le halal

Suisse

CARBOGEN AMCIS | Aarau

CARBOGEN AMCIS

Développement et fabrication cGMP à moyenne échelle, y compris la chromatographie.

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TAILLE DU LOT: Petit, Moyen

COMPLIANCE: PMDA/MHLW (Japan GMP), Organisation mondiale de la santé (BPF / HACCP), FDA (cGMP), ISO

CATÉGORIE / PRODUIT: SERVICES, PARTICLE ENGINEERING, BIOLOGIE, CHEMICAL-SYNTHETIC

RÉGION: Europe

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

USAGE: Humain, Vétérinaire

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

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

Suisse

CARBOGEN AMCIS | Bubendorf

CARBOGEN AMCIS

Développement et fabrication cGMP d'API hautement puissants, y compris des conjugués anticorps-médicament (ADC).

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MARCHÉS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

TAILLE DU LOT: Petit, Moyen

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (B) Blood and blood forming organs

COMPLIANCE: EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), FDA (cGMP), ISO

CATÉGORIE / PRODUIT: SERVICES, PARTICLE ENGINEERING, BIOLOGIE, CHEMICAL-SYNTHETIC

RÉGION: Europe

USAGE: Humain, Vétérinaire

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

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