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).
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
Avara Pharmaceutical Services | Norman Site
AVARA
Installation de fabrication sous contrat spécialisée dans le dosage oral solide (OSD) pour l'approvisionnement clinique et commercial.
TAILLE DU LOT: Petit, 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), 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
TRADICHEM INDUSTRIAL SERVICES
TRADICHEM INDUSTRIAL SERVICES S.L.
TECHNOLOGIE HIPING® - LA PASSERELLE POUR LE LEAN MANUFACTURING
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
COMPLIANCE: EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP), FDA (cGMP), ISO
CATÉGORIE / PRODUIT: SERVICES, PARTICLE ENGINEERING, NUTRACEUTICALS
RÉGION: Europe
USAGE: Humain, Vétérinaire
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)
SERVICES: Manufacturing services, Development services
MARCHÉS: FDA (USA), EMA (EU)
BSL (niveau de sécurité biologique): 1, 2
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Une installation de fabrication API et intermédiaire approuvée par l'USFDA.
Location available after registration
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Usine d'inhalation de poudre sèche.
Location available after registration
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Installation Chimique-Pharmaceutique
Location available after registration
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