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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Une installation de fabrication API et intermédiaire approuvée par l'USFDA.

Location available after registration

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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Installation Chimique-Pharmaceutique

Location available after registration

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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).

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
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.

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

Adare Pharma | US
États-Unis

Adare Pharma | US

Adare Pharma Solutions

Adare Pharma est un CDMO mondial avec installations en EE.UU. et l'UE, qui ofrece desarrollo de productos lave en mano mediante experiencia en fabricación comer

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

TAILLE DU LOT: Petit, Moyen, Grandes dimensions

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING

COMPLIANCE: EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), Service public français (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (BPF de Chine), ECOVADIS, ISO, Conseil de recherche sur le halal, Santé Canada (Canada GMP), TITCK (Turkish Health Authorities), MFDS/KFDA (République de Corée GMP)

USAGE: Humain, Vétérinaire

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

RÉGION: North America

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (A) Digestive tract and metabolism

Adare Pharma | EU
Italie

Adare Pharma | EU

Adare Pharma Solutions

CDMO mondial proposant le développement de produits clé en main grâce à une expertise en fabrication commerciale, axé sur les formes posologiques orales.

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

TAILLE DU LOT: Petit, Moyen, Grandes dimensions

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (V01) Allergens, (M) Musculoskeletal system, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING

COMPLIANCE: EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), Service public français (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (BPF de Chine), ECOVADIS, ISO, Conseil de recherche sur le halal, Santé Canada (Canada GMP), TITCK (Turkish Health Authorities), MFDS/KFDA (République de Corée GMP)

RÉGION: Europe

USAGE: Humain, Vétérinaire

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

PHARMALOOP S.L. - a Salvat Company
Espagne

PHARMALOOP S.L. - a Salvat Company

Laboratorios Salvat

Solutions CDMO entièrement intégrées pour Blow-Fill-Seal (BFS), multidoses stériles, multidoses non stériles, sachets, gélules et comprimés.

TAILLE DU LOT: Petit, Moyen, Grandes dimensions

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING

COMPLIANCE: EMA (BPF DE L'UE), FDA (cGMP), ISO

RÉGION: Europe

USAGE: Humain

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

MARCHÉS: FDA (USA), EMA (EU)

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (V01) Allergens, (S) Sensory organs

BSL (niveau de sécurité biologique): 1

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

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Usine d'inhalation de poudre sèche.

Location available after registration

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Services de R&D et d'analyse, transfert de technologie et introduction de nouveaux produits, et fabrication de formes posologiques orales solides et liquides.

Location available after registration

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Votre CDMO GMP de confiance pour la fabrication avancée de produits pharmaceutiques aseptiques et non aseptiques, le développement de formulations et les tests

Location available after registration