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SERVICES manufacturing site
MAI network supplier
CMO certificato EU-GMP con sede a Martin, Slovacchia. L'azienda fornisce servizi di produzione e confezionamento di prodotti farmaceutici sterili. prodotti e fo
Location available after registration
COSMETICI manufacturing site
MAI network supplier
Soluzioni CDMO one-stop per APl e intermediari chiave.
Location available after registration
COSMETICI manufacturing site
MAI network supplier
Impianto Chimico-Farmaceutico
Location available after registration
These facilities match your main criteria but not all optional filters.
Laboratorio REIG JOFRE, SA (TOLEDO PLANT)
LABORATORIO REIG JOFRE SA
Impianti all'avanguardia per lo sviluppo e la produzione di antibiotici betalattamici (FDF).
MERCATI: EMA (EU), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), INVIMA (Colombia), SFDA (Saudi Arabia), TGA (Australia)
REGIONE: APAC, MENA, LATAM, Europe, North America
COMPLIANCE: DIGEMID, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP)
DIMENSIONE DEL LOTTO: Grande, Medio
USO: Umano, Veterinario
BSL (Livello di sicurezza biologica): 1
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
AREE TERAPEUTICHE DI COMPETENZA (ATC): (J) Antiinfectives for systemic use
SOSTANZE CONTROLLATE: Lowest potential for abuse
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
Upperton Pharma Solutions
Upperton Pharma Solutions
Sviluppo e produzione di prodotti farmaceutici liquidi a dose solida orale (OSD), nasali, per inalazione e sterili in polvere secca e liquida.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
SOSTANZE CONTROLLATE: 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
MERCATI: EMA (EU), FDA (USA), Health Canada (Canada), MHRA (UK), TGA (Australia)
REGIONE: Europe
USO: Umano
CATEGORIA / PRODOTTO: OLIGONUCLEOTIDI, BIOLOGIA, SERVICES, FDF / DRUG PRODUCTS
BSL (Livello di sicurezza biologica): 1
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (N) Nervous system, (R) Respiratory system
DIMENSIONE DEL LOTTO: Piccolo, Medio
COMPLIANCE: MHRA (UK GMP)
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).
SOSTANZE CONTROLLATE: 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 (GMP UE), Health Canada (Canada GMP), MFDS/KFDA (Repubblica di Corea GMP)
MERCATI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), TGA (Australia)
DIMENSIONE DEL LOTTO: Grande, Medio
USO: Umano
CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC, SERVICES, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
SERVIZI: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
AREE TERAPEUTICHE DI COMPETENZA (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
REGIONE: North America
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
Avara Pharmaceutical Services | Norman Site
AVARA
Impianto di produzione a contratto specializzato nel dosaggio solido orale (OSD) per la fornitura clinica e commerciale.
SOSTANZE CONTROLLATE: 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 (GMP UE), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP)
MERCATI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea), TGA (Australia)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano
CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC, SERVICES, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
AREE TERAPEUTICHE DI COMPETENZA (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
REGIONE: North America
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
Sidefarma
Sidefarma SA
CMO specializzata nella produzione di lotti di piccole e medie dimensioni per aziende farmaceutiche di tutto il mondo nei mercati regolamentati.
SOSTANZE CONTROLLATE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MERCATI: EMA (EU), PMDA (Japan), Health Canada (Canada), DIGEMID (Peru), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), TGA (Australia)
REGIONE: Europe
COMPLIANCE: ISO, UAE Ministry of Health & Prevention, EMA (GMP UE)
USO: Umano
SERVIZI: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
DIMENSIONE DEL LOTTO: Piccolo, Medio
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
MERCATI: 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)
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: 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), Servizio pubblico francese (CIR), NMPA (Cina GMP), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano
AREE TERAPEUTICHE DI COMPETENZA (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
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
Aenova Group - Location Tittmoning, Germany
Aenova
Centro di competenza Impianto per solidi convenzionali ad alto volume.
MERCATI: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, TGA (Australia)
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (GMP UE), Health Canada (Canada GMP)
DIMENSIONE DEL LOTTO: Grande, Medio
CATEGORIA / PRODOTTO: NUTRACEUTICI, FDF / DRUG PRODUCTS
USO: Umano, Veterinario
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
Aenova Group - Location Sisseln, Switzerland
Aenova
Centro di competenza solidi convenzionali complessi.
REGIONE: Europe
MERCATI: FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities
COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MFDS/KFDA (Repubblica di Corea GMP)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
CATEGORIA / PRODOTTO: NUTRACEUTICI, FDF / DRUG PRODUCTS
USO: Umano
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
Aenova Group - Location Regensburg, Germany
Aenova
Centro di competenza solidi ad alta potenza (oncologia) solidi convenzionali - semisolidi e liquidi speciali.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
MERCATI: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities
REGIONE: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (GMP UE), MFDS/KFDA (Repubblica di Corea GMP)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
CATEGORIA / PRODOTTO: COSMETICI, NUTRACEUTICI, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
USO: Umano, Veterinario
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
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