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Aenova Group - Location Kirchberg, Switzerland
Suisse

Aenova Group - Location Kirchberg, Switzerland

Aenova

Centre de compétences Capsules de gélatine molle.

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), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)

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

RÉGION: Europe

COMPLIANCE: FDA (cGMP), ISO, Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP), MFDS/KFDA (République de Corée GMP)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

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

USAGE: Humain, Vétérinaire

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V06) Nutrients, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

Aenova Group - Location Killorglin, Ireland
Irlande

Aenova Group - Location Killorglin, Ireland

Aenova

Centre de compétence pour le séchage par pulvérisation et les pellets à libération modifiée.

MARCHÉS: EMA (EU), PMDA (Japan), SFDA (Saudi Arabia), MFDS (South Korea)

RÉGION: Europe

COMPLIANCE: ISO, PMDA/MHLW (Japan GMP), 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: NUTRACEUTICALS, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING

USAGE: Humain, Vétérinaire

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)

Aenova Group - Location Gronau, Germany
Allemagne

Aenova Group - Location Gronau, Germany

Aenova

Centre de compétences pour les solides conventionnels et les services cliniques.

MARCHÉS: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, EDE (UAE)

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

RÉGION: Europe

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), UAE Ministry of Health & Prevention, EMA (BPF DE L'UE)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain, Vétérinaire

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

Aenova Group - Location Greensboro, USA
États-Unis

Aenova Group - Location Greensboro, USA

Aenova

Centre de compétences pour les solides d'emballage.

SERVICES: Logistics, Manufacturing services, Packaging

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

COMPLIANCE: FDA (cGMP), Conseil de recherche sur le halal, Santé Canada (Canada GMP), NSF

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

CATÉGORIE / PRODUIT: NUTRACEUTICALS

USAGE: Humain

RÉGION: North America

Aenova Group - Location Feldkirchen, Germany
Allemagne

Aenova Group - Location Feldkirchen, Germany

Aenova

Centre de Compétence Semisolides et Liquides.

MARCHÉS: EMA (EU), FDA (USA), Russian Health Authorities

RÉGION: Europe

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

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

CATÉGORIE / PRODUIT: COSMETICS, FDF / DRUG PRODUCTS

USAGE: Humain, Vétérinaire

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

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system

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)

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 / DRUG PRODUCTS

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)

Aenova Group - Location Bad Aibling, Germany
Allemagne

Aenova Group - Location Bad Aibling, Germany

Aenova

Centre de Compétence Emballage Blister Emballage tiers Installation à grand volume pour effervescents.

MARCHÉS: EMA (EU), FDA (USA)

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

RÉGION: Europe

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

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

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

USAGE: Humain, Vétérinaire

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 Carugate, Italy
Italie

Aenova Group - Location Carugate, Italy

Aenova

Centre de compétence Semi-solides et liquides non stériles.

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), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia)

RÉGION: Europe

COMPLIANCE: ISO, Roszdravnadzor (Russia GMP), SFDA (Saudi Food & Drug Authority), EMA (BPF DE L'UE)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

CATÉGORIE / PRODUIT: COSMETICS, FDF / DRUG PRODUCTS

USAGE: Humain, Vétérinaire

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

AdhexPharma SAS
France

AdhexPharma SAS

AdhexPharma

CDMO pour patchs transdermiques et films oro-muqueux.

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), MHRA (UK)

RÉGION: Europe

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

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain, Vétérinaire

SERVICES: Development services, Manufacturing services, Analytical / QC services

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (N) Nervous system

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

TRADICHEM INDUSTRIAL SERVICES
Espagne

TRADICHEM INDUSTRIAL SERVICES

TRADICHEM INDUSTRIAL SERVICES S.L.

TECHNOLOGIE HIPING® - LA PASSERELLE POUR LE LEAN MANUFACTURING

MARCHÉS: EMA (EU), FDA (USA)

RÉGION: Europe

COMPLIANCE: FDA (cGMP), ISO, EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

CATÉGORIE / PRODUIT: NUTRACEUTICALS, SERVICES, PARTICLE ENGINEERING

USAGE: Humain, Vétérinaire

BSL (niveau de sécurité biologique): 1, 2

SERVICES: Development services, Manufacturing services

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 / DRUG PRODUCTS

Northway Biotech Vilnius
Lituanie

Northway Biotech Vilnius

Northway Biotech

CDMO global de services intégraux en biologie

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

MARCHÉS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)

RÉGION: Europe

COMPLIANCE: FDA (cGMP), ISO, SFDA (Saudi Food & Drug Authority), Service public français (CIR), EMA (BPF DE L'UE)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain, Vétérinaire

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

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

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

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