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Laboratorio REIG JOFRE, SA (TOLEDO PLANT)
Espagne

Laboratorio REIG JOFRE, SA (TOLEDO PLANT)

LABORATORIO REIG JOFRE SA

Installations de développement et de fabrication de bêtalactamines (FDF) à la pointe de la technologie.

MARCHÉS: EMA (EU), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), INVIMA (Colombia), SFDA (Saudi Arabia), TGA (Australia)

RÉGION: 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 (BPF DE L'UE), Santé Canada (Canada GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI)

TAILLE DU LOT: Grandes dimensions, Moyen

USAGE: Humain, Vétérinaire

BSL (niveau de sécurité biologique): 1

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

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (J) Antiinfectives for systemic use

SUBSTANCES CONTRÔLÉES: Lowest potential for abuse

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

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS

Upperton Pharma Solutions
Royaume-Uni

Upperton Pharma Solutions

Upperton Pharma Solutions

Développement et fabrication de produits pharmaceutiques sous forme de poudres et de liquides secs et stériles à dose orale solide (OSD), nasale, pour inhalatio

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), FDA (USA), Health Canada (Canada), MHRA (UK), TGA (Australia)

RÉGION: Europe

USAGE: Humain

CATÉGORIE / PRODUIT: OLIGONUCLÉOTIDES, BIOLOGIE, SERVICES, FDF / DRUG PRODUCTS

BSL (niveau de sécurité biologique): 1

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

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (N) Nervous system, (R) Respiratory system

TAILLE DU LOT: Petit, Moyen

COMPLIANCE: MHRA (BPF AU ROYAUME-UNI)

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

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: North America

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

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: North America

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)

Sidefarma
Portugal

Sidefarma

Sidefarma SA

CMO est spécialisé dans la fabrication de lots de petite et moyenne taille pour les sociétés pharmaceutiques du monde entier sur les marchés réglementés.

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), Health Canada (Canada), DIGEMID (Peru), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), TGA (Australia)

RÉGION: Europe

COMPLIANCE: ISO, UAE Ministry of Health & Prevention, EMA (BPF DE L'UE)

USAGE: Humain

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

TAILLE DU LOT: Petit, Moyen

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 / DRUG PRODUCTS

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 / DRUG PRODUCTS

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

Aenova Group - Location Tittmoning, Germany
Allemagne

Aenova Group - Location Tittmoning, Germany

Aenova

Centre de compétence usine conventionnelle de solides à haut volume.

MARCHÉS: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, TGA (Australia)

RÉGION: Europe

COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP)

TAILLE DU LOT: Grandes dimensions, Moyen

CATÉGORIE / PRODUIT: NUTRACEUTICALS, FDF / DRUG PRODUCTS

USAGE: Humain, Vétérinaire

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

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)

Aenova Group - Location Sisseln, Switzerland
Suisse

Aenova Group - Location Sisseln, Switzerland

Aenova

Centre de compétences solides conventionnels complexes.

RÉGION: Europe

MARCHÉS: FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities

COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), Organisation mondiale de la santé (BPF / HACCP), MFDS/KFDA (République de Corée GMP)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

CATÉGORIE / PRODUIT: NUTRACEUTICALS, FDF / DRUG PRODUCTS

USAGE: Humain

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

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)

Aenova Group - Location Regensburg, Germany
Allemagne

Aenova Group - Location Regensburg, Germany

Aenova

Centre de compétences solides hautement puissants (oncologie) solides conventionnels - semi-solides et liquides spécialisés.

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), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities

RÉGION: 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 (BPF DE L'UE), MFDS/KFDA (République de Corée GMP)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

CATÉGORIE / PRODUIT: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING

USAGE: Humain, Vétérinaire

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

Aenova Group - Location Münster, Germany
Allemagne

Aenova Group - Location Münster, Germany

Aenova

Centre de compétence solides à faible dose et haute puissance (hormones, hormon-like), capsules à faible dose.

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), FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities

RÉGION: Europe

COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (BPF DE L'UE), MFDS/KFDA (République de Corée GMP)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain, Vétérinaire

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

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS

Aenova Group - Location Marburg, Germany
Allemagne

Aenova Group - Location Marburg, Germany

Aenova

Centre de compétences complexe pour les solides conventionnels et les stupéfiants.

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), FDA (USA), ANVISA (Brazil), Russian Health Authorities

RÉGION: Europe

COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

CATÉGORIE / PRODUIT: NUTRACEUTICALS, FDF / DRUG PRODUCTS

USAGE: Humain

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

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)

Aenova Group - Location Latina, Italy
Italie

Aenova Group - Location Latina, Italy

Aenova

Centre de compétences produits de santé animale et technologies stériles.

MARCHÉS: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities

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

RÉGION: Europe

COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (BPF DE L'UE)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain, Vétérinaire

BSL (niveau de sécurité biologique): 1, 2

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 / DRUG PRODUCTS

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