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CARBOGEN AMCIS | Veenendaal
Paesi Bassi

CARBOGEN AMCIS | Veenendaal

CARBOGEN AMCIS

Produzione su larga scala di analoghi del colesterolo e della vitamina D.

AREE TERAPEUTICHE DI COMPETENZA (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 (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

MERCATI: 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

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

REGIONE: Europa

COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Consiglio di ricerca halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), Servizio pubblico francese (CIR), NMPA (Cina GMP), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP), SQF (alimenti di qualità sicuri), NSF

USO: Umano, Veterinario

BSL (Livello di sicurezza biologica): 1

CATEGORIA / PRODOTTO: CHIMICO-SINTETICO, SERVIZI

DIMENSIONE DEL LOTTO: Piccolo

CARBOGEN AMCIS | Shanghai, China
Cina

CARBOGEN AMCIS | Shanghai, China

CARBOGEN AMCIS

Produzione su larga scala.

AREE TERAPEUTICHE DI COMPETENZA (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

MERCATI: 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

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

REGIONE: APAC

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano

CATEGORIA / PRODOTTO: OLIGONUCLEOTIDI, CHIMICO-SINTETICO, SERVIZI

COMPLIANCE: ANVISA (Brazil B-GMP), NMPA (Cina GMP)

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

CARBOGEN AMCIS | Saint-Beauzire
Francia

CARBOGEN AMCIS | Saint-Beauzire

CARBOGEN AMCIS

Sviluppo di formulazioni personalizzate e produzione sterile GMP di prodotti farmaceutici liquidi e liofilizzati.

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

SOSTANZE CONTROLLATE: 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

MERCATI: 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

REGIONE: Europa

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), Servizio pubblico francese (CIR), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano

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

AREE TERAPEUTICHE DI COMPETENZA (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, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

CATEGORIA / PRODOTTO: DFF / PRODOTTI MEDICINALI

CARBOGEN AMCIS | Bubendorf
Svizzera

CARBOGEN AMCIS | Bubendorf

CARBOGEN AMCIS

Sviluppo e produzione cGMP di API altamente potenti, inclusi coniugati di farmaci anticorpali (ADC).

MERCATI: 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)

REGIONE: Europa

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP)

USO: Umano, Veterinario

CATEGORIA / PRODOTTO: CHIMICO-SINTETICO, BIOLOGIA, SERVIZI, INGEGNERIA DELLE PARTICELLE

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

AREE TERAPEUTICHE DI COMPETENZA (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 (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

DIMENSIONE DEL LOTTO: Piccolo, Medio

Apeloa Pharmaceutical Co., Ltd.
Cina

Apeloa Pharmaceutical Co., Ltd.

Apeloa Pharmaceutical Co., Ltd

Apeloa CDMO fornisce servizi di scoperta, sviluppo e produzione di livello mondiale per API, prodotti intermedi e RSM.

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

MERCATI: 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)

REGIONE: APAC

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ECOVADIS, NMPA (Cina GMP), EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano, Veterinario

CATEGORIA / PRODOTTO: CHIMICO-SINTETICO

SERVIZI: Development services, Manufacturing services, Analytical / QC services, Regulatory services, Packaging

Aenova Group - Location Regensburg, Germany
Germania

Aenova Group - Location Regensburg, Germany

Aenova

Centro di competenza solidi ad alta potenza (oncologia) solidi convenzionali - semisolidi e liquidi speciali.

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

MERCATI: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities

REGIONE: Europa

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (GMP UE), MFDS/KFDA (Repubblica di Corea GMP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: COSMETICI, NUTRACEUTICI, DFF / PRODOTTI MEDICINALI, INGEGNERIA DELLE PARTICELLE

USO: Umano, Veterinario

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

Aenova Group - Location Münster, Germany
Germania

Aenova Group - Location Münster, Germany

Aenova

Competence Center solidi potenti a basso dosaggio (ormoni, simili agli ormoni), capsule a basso dosaggio.

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

MERCATI: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities

REGIONE: Europa

COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (GMP UE), MFDS/KFDA (Repubblica di Corea GMP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano, Veterinario

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

AREE TERAPEUTICHE DI COMPETENZA (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins

CATEGORIA / PRODOTTO: DFF / PRODOTTI MEDICINALI

Aenova Group - Location Kirchberg, Switzerland
Svizzera

Aenova Group - Location Kirchberg, Switzerland

Aenova

Centro di competenza Capsule di gelatina morbida.

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

MERCATI: EMA (EU), FDA (USA), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)

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

REGIONE: Europa

COMPLIANCE: FDA (cGMP), ISO, Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP), MFDS/KFDA (Repubblica di Corea GMP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: COSMETICI, NUTRACEUTICI, DFF / PRODOTTI MEDICINALI

USO: Umano, Veterinario

AREE TERAPEUTICHE DI COMPETENZA (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 Feldkirchen, Germany
Germania

Aenova Group - Location Feldkirchen, Germany

Aenova

Centro di Competenza Semisolidi e Liquidi.

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

REGIONE: Europa

COMPLIANCE: FDA (cGMP), ISO, Roszdravnadzor (Russia GMP), EMA (GMP UE)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: COSMETICI, DFF / PRODOTTI MEDICINALI

USO: Umano, Veterinario

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

AREE TERAPEUTICHE DI COMPETENZA (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

Aenova Group - Location Carugate, Italy
Italia

Aenova Group - Location Carugate, Italy

Aenova

Centro di Competenza Semisolidi e liquidi non sterili.

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

MERCATI: EMA (EU), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia)

REGIONE: Europa

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

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: COSMETICI, DFF / PRODOTTI MEDICINALI

USO: Umano, Veterinario

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

GENSENTA ILAC SANAYI AS
Turchia

GENSENTA ILAC SANAYI AS

GENSENTA

PRODUTTORE CMO & CDMO & FDF

SOSTANZE CONTROLLATE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MERCATI: 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)

REGIONE: Europa

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano

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

AREE TERAPEUTICHE DI COMPETENZA (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 (GMP UE), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP)

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

CATEGORIA / PRODOTTO: SERVIZI, DFF / PRODOTTI MEDICINALI

Adragos Pharma |  Athens
Grecia

Adragos Pharma | Athens

Adragos Pharma

È specializzato nello sviluppo di farmaci a valore aggiunto ed è stato recentemente aggiornato con funzionalità HPAPI.

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

SOSTANZE CONTROLLATE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MERCATI: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)

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

REGIONE: Europa

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), UAE Ministry of Health & Prevention, NMPA (Cina GMP), EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP), NSF

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano

CATEGORIA / PRODOTTO: SERVIZI, DFF / PRODOTTI MEDICINALI

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