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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)

Northway Biotech Waltham (MA)
États-Unis

Northway Biotech Waltham (MA)

Northway Biotech

CDMO mondial de bout en bout pour les produits biologiques

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)

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), 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

RÉGION: North America

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

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

Green Phoenix Labs GmbH
Allemagne

Green Phoenix Labs GmbH

Green Phoenix Labs GmbH

Entreprise de thérapie cellulaire avec une capacité excédentaire de salle blanche.

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system

SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

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)

COMPLIANCE: EMA (BPF DE L'UE)

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

MARCHÉS: EMA (EU)

SERVICES: Logistics, Development services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging

RÉGION: Europe

USAGE: Humain

BSL (niveau de sécurité biologique): 1

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: APAC

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: CHEMICAL-SYNTHETIC

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 / DRUG PRODUCTS, CHEMICAL-SYNTHETIC

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: APAC

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain

SENN Chemicals | GMP Production | Dielsdorf, Switzerland
Suisse

SENN Chemicals | GMP Production | Dielsdorf, Switzerland

Senn Chemicals

Site de production suisse cGMP pour la fabrication de LPPS, SPPS et peptides hybrides, de l'échelle pilote à l'échelle commerciale précoce.

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

RÉGION: Europe

TAILLE DU LOT: Grandes dimensions, Moyen

CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING

SENN Chemicals | Small Scale GMP Lab | Dielsdorf, Switzerland
Suisse

SENN Chemicals | Small Scale GMP Lab | Dielsdorf, Switzerland

Senn Chemicals

Laboratoire de synthèse de peptides et de substances organiques GMP à petite échelle pour des projets cliniques, de niche et de grande valeur nécessitant une pr

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

RÉGION: Europe

CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING

TAILLE DU LOT: Petit

SENN Chemicals | R&D and Kilo Lab | Dielsdorf, Switzerland
Suisse

SENN Chemicals | R&D and Kilo Lab | Dielsdorf, Switzerland

Senn Chemicals

Site suisse de R&D sur les peptides et les intermédiaires peptidiques avec SPPS, LPPS, synthèse hybride, mise à l'échelle en kilo lab, purification et analyse.

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

RÉGION: Europe

CATÉGORIE / PRODUIT: COSMETICS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING

TAILLE DU LOT: Petit

Limited view

CHEMICAL-SYNTHETIC manufacturing site

MAI network supplier

CRO/CMO pharmaceutique

Location available after registration

Limited view

CHEMICAL-SYNTHETIC manufacturing site

MAI network supplier

Un fabricant API et intermédiaire ayant des certifications mondiales.

Location available after registration

Limited view

BIOLOGIE manufacturing site

MAI network supplier

Installation de fabrication de produits biologiques conforme aux BPF, spécialisée dans les enzymes et les protéines recombinantes.

Location available after registration

Limited view

COSMETICS manufacturing site

MAI network supplier

Site de développement et de fabrication de substances médicamenteuses à petites molécules.

Location available after registration

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