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Stati Uniti
Avara Pharmaceutical Services | Arecibo Site
AVARA
Impianto di produzione di dosaggi solidi orali (OSD) su scala commerciale con una forte esperienza nelle sostanze controllate (DEA II V).
DIMENSIONE DEL LOTTO: Medio, Grande
AREE TERAPEUTICHE DI COMPETENZA (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
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (GMP UE), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), Health Canada (Canada GMP), MFDS/KFDA (Repubblica di Corea GMP), ICH
SOSTANZE CONTROLLATE: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
MERCATI: ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada)
USO: Umano
SERVIZI: Analytical / QC services, Manufacturing services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
REGIONE: North America
Stati Uniti
Avara Pharmaceutical Services | Norman Site
AVARA
Impianto di produzione a contratto specializzato nel dosaggio solido orale (OSD) per la fornitura clinica e commerciale.
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
AREE TERAPEUTICHE DI COMPETENZA (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
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (GMP UE), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), Health Canada (Canada GMP), MFDS/KFDA (Repubblica di Corea GMP), ICH
SOSTANZE CONTROLLATE: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
MERCATI: ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada), MHRA (UK)
USO: Umano
SERVIZI: Analytical / QC services, Manufacturing services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
REGIONE: North America
Spagna
TRADICHEM INDUSTRIAL SERVICES
TRADICHEM INDUSTRIAL SERVICES S.L.
TECNOLOGIA HIPERING® - LA PORTA PER LA PRODUZIONE Snella
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
COMPLIANCE: EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP), FDA (cGMP), ISO
CATEGORIA / PRODOTTO: SERVICES, PARTICLE ENGINEERING, NUTRACEUTICI
REGIONE: Europe
USO: Umano, Veterinario
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
SERVIZI: Manufacturing services, Development services
MERCATI: FDA (USA), EMA (EU)
BSL (Livello di sicurezza biologica): 1, 2
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Una struttura API e produzione intermedia approvata dalla USFDA.
Location available after registration
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Impianto per inalazione di polvere secca.
Location available after registration
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Impianto Chimico-Farmaceutico
Location available after registration
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