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Aenova Group - Location Cornu, Romania
Roumanie

Aenova Group - Location Cornu, Romania

Aenova

Centre de compétences et guichet unique pour les capsules de gélatine molle et les VegaGels®.

RÉGION: Europe

MARCHÉS: FDA (USA), Health Canada (Canada), TGA (Australia)

COMPLIANCE: FDA (cGMP), ISO, Conseil de recherche sur le halal, TGA (Australia GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

CATÉGORIE / PRODUIT: NUTRACEUTICALS, FDF / PRODUITS MÉDICAMENTEUX

USAGE: Humain

SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance 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)

GENSENTA ILAC SANAYI AS
Turquie

GENSENTA ILAC SANAYI AS

GENSENTA

FABRICANT CMO & CDMO & FDF

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), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)

RÉGION: Europe

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain

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

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (A) Digestive tract and metabolism

COMPLIANCE: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (BPF DE L'UE), Santé Canada (Canada GMP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP)

OEB (bandes d´exposition professionnelle): 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)

CATÉGORIE / PRODUIT: SERVICES, FDF / PRODUITS MÉDICAMENTEUX

Adragos Pharma | Halden
Norvège

Adragos Pharma | Halden

Adragos Pharma

Nous sommes spécialisés dans la fabrication de poches IV, d'ampoules et de flacons en plastique utilisant la technologie Blow-Fill-Seal (BFS) et d'autres formes

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), NMPA (China), FDA (USA), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), TGA (Australia)

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

RÉGION: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, NMPA (BPF de Chine), EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP), NSF

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (D) Dermatologicals, (V06) Nutrients, (A) Digestive tract and metabolism

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 / PRODUITS MÉDICAMENTEUX

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: 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), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), TGA (Australia)

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

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Conseil de recherche sur le halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, Service public français (CIR), NMPA (BPF de Chine), 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, Vétérinaire

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

OEB (bandes d´exposition professionnelle): 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)

RÉGION: Amérique du Nord

CATÉGORIE / PRODUIT: SERVICES, FDF / PRODUITS MÉDICAMENTEUX, INGÉNIERIE DES PARTICULES

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.

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

MARCHÉS: TGA (Australia), 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), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)

COMPLIANCE: Service public français (CIR), NMPA (BPF de Chine), 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), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Conseil de recherche sur le halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention

TAILLE DU LOT: Petit, Moyen, Grandes dimensions

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), 4 / HPAPI (PDE = 10 - 100 µg/jour)

CATÉGORIE / PRODUIT: SERVICES, FDF / PRODUITS MÉDICAMENTEUX, INGÉNIERIE DES PARTICULES

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

RÉGION: Europe

USAGE: Humain, Vétérinaire

Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site
Chine

Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site

Seacross Pharmaceutical Co Ltd

En tant que l'un des trois sites principaux, aux côtés du centre de R&D et de l'usine de formulation, notre usine de fabrication d'API joue un rôle essentiel da

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), 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), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

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

RÉGION: Asie-Pacifique

COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Conseil de recherche sur le halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), 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), SQF (Safe Quality Food), NSF

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain

BSL (niveau de sécurité biologique): 1, 2, 3, 4

CATÉGORIE / PRODUIT: CHIMIQUE-SYNTHÉTIQUE

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (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, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones, (V04) Diagnostic agents

OEB (bandes d´exposition professionnelle): 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), 5 / HPAPI (PDE < 10 µg/day)

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
Chine

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site

Seacross Pharmaceutical Co Ltd

Le centre de R&D joue un rôle fondamental en soutenant le développement d’API et de formes posologiques finies.

COMPLIANCE: MFDS/KFDA (République de Corée GMP), SQF (Safe Quality Food), NSF, DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Conseil de recherche sur le halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), 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)

CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX, CHIMIQUE-SYNTHÉTIQUE

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

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (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, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

BSL (niveau de sécurité biologique): 3, 4, 1, 2

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), 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), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

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

RÉGION: Asie-Pacifique

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain

Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site
Chine

Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site

Seacross Pharmaceutical Co Ltd

Le site de fabrication de formulations est dédié au développement et à la production de formes galéniques complexes et de grande valeur.

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (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, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

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)

BSL (niveau de sécurité biologique): 3, 4, 1, 2

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), 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), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

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

RÉGION: Asie-Pacifique

COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Conseil de recherche sur le halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), 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), SQF (Safe Quality Food), NSF

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain

CATÉGORIE / PRODUIT: SERVICES, FDF / PRODUITS MÉDICAMENTEUX

Cenexi Laboratoires Thissen
Belgique

Cenexi Laboratoires Thissen

Cenexi

Cette usine de 8.000 m2, répartie sur un terrain de près de sept hectares, est située à 20 km au sud de Bruxelles et compte 340 salariés*.

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)

BSL (niveau de sécurité biologique): 3, 4, 1, 2

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), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), TGA (Australia)

RÉGION: Europe

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), NMPA (BPF de Chine), 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, 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, (L) Antineoplastic and immunomodulating agents, (G) Genito urinary system and sex hormones

CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX

Limited view

SERVICES manufacturing site

MAI network supplier

OGM certifiée EU-GMP basée à Martin, Slovaquie. L'entreprise fournit des services de fabrication et d'emballage de produits pharmaceutiques stériles. produits e

Location available after registration

Limited view

CHIMIQUE-SYNTHÉTIQUE manufacturing site

MAI network supplier

CDMO européen spécialisé dans les stéroïdes, hormones et HPAPI.

Location available after registration

Limited view

FDF / PRODUITS MÉDICAMENTEUX manufacturing site

MAI network supplier

Fournisseur leader de services de fabrication de produits pharmaceutiques stériles, exploitant une installation de pointe en Inde

Location available after registration

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