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Hikal Ltd | Bangalore, India
Hikal Ltd.
Développement de processus cGMP, mise à l'échelle et fabrication d'API, de NME et d'intermédiaires à petites molécules, des grammes aux tonnes.
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), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), 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
RÉGION: APAC
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), COFEPRIS, Conseil de recherche sur le halal, ECOVADIS, TGA (Australia GMP), EMA (BPF DE L'UE)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
CATÉGORIE / PRODUIT: COSMETICS, NUTRACEUTICALS, CHEMICAL-SYNTHETIC, SERVICES
USAGE: Humain, Vétérinaire
SERVICES: Development services, Manufacturing services
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (V06) Nutrients
CARBOGEN AMCIS | Vionnaz
CARBOGEN AMCIS
Développement d'API très puissantes et production de cGMP à petite échelle, y compris la chromatographie et la lyophilisation.
MARCHÉS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP)
USAGE: Humain, Vétérinaire
CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services
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)
TAILLE DU LOT: Petit
CARBOGEN AMCIS | Veenendaal
CARBOGEN AMCIS
Fabrication à grande échelle d’analogues du cholestérol et de la vitamine D.
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
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), 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: Europe
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
USAGE: Humain, Vétérinaire
BSL (niveau de sécurité biologique): 1
CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC, SERVICES
TAILLE DU LOT: Petit
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism
MARCHÉS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), 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
CATÉGORIE / PRODUIT: OLIGONUCLÉOTIDES, CHEMICAL-SYNTHETIC, SERVICES
COMPLIANCE: ANVISA (Brazil B-GMP), NMPA (BPF de Chine)
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)
MARCHÉS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)
RÉGION: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), Organisation mondiale de la santé (BPF / HACCP)
USAGE: Humain, Vétérinaire
CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC, SERVICES
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
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)
CARBOGEN AMCIS | Manchester, UK
CARBOGEN AMCIS
Découvrez nos capacités de fabrication d'ingrédients cosmétiques, de chimie fine et de synthèse personnalisée d'intermédiaires pharmaceutiques.
RÉGION: Europe
COMPLIANCE: ISO, Conseil de recherche sur le halal, ECOVADIS
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING
SERVICES: Development services, Manufacturing services, Analytical / QC services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CARBOGEN AMCIS | Aarau
CARBOGEN AMCIS
Développement et fabrication cGMP à moyenne échelle, y compris la chromatographie.
MARCHÉS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), Organisation mondiale de la santé (BPF / HACCP)
USAGE: Humain, Vétérinaire
CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC, BIOLOGIE, SERVICES, PARTICLE ENGINEERING
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services
TAILLE DU LOT: Petit, Moyen
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CARBOGEN AMCIS | Bubendorf
CARBOGEN AMCIS
Développement et fabrication cGMP d'API hautement puissants, y compris des conjugués anticorps-médicament (ADC).
MARCHÉS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP)
USAGE: Humain, Vétérinaire
CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC, BIOLOGIE, SERVICES, PARTICLE ENGINEERING
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (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)
TAILLE DU LOT: Petit, Moyen
Apeloa Pharmaceutical Co., Ltd.
Apeloa Pharmaceutical Co., Ltd
Apeloa CDMO fournit des services de découverte, de développement et de fabrication de classe mondiale pour les API, les intermédiaires et les RSM.
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), 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)
RÉGION: APAC
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ECOVADIS, NMPA (BPF de Chine), EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain, Vétérinaire
CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC
SERVICES: Development services, Manufacturing services, Analytical / QC services, Regulatory services, Packaging
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
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
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
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