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Aenova Group - Location Marburg, Germany
Germania

Aenova Group - Location Marburg, Germany

Aenova

Centro di competenza solidi convenzionali complessi e narcotici.

DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande

CATEGORIA / PRODOTTO: DFF / PRODOTTI MEDICINALI, NUTRACEUTICI

COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (GMP UE), ANVISA (Brazil B-GMP), FDA (cGMP)

SOSTANZE CONTROLLATE: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse

REGIONE: Europa

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

USO: Umano

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

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

Aenova Group - Location Latina, Italy
Italia

Aenova Group - Location Latina, Italy

Aenova

Centro di Competenza prodotti per la sanità animale e tecnologie sterili.

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

DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande

CATEGORIA / PRODOTTO: DFF / PRODOTTI MEDICINALI

COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (GMP UE), ANVISA (Brazil B-GMP), FDA (cGMP), SFDA (Saudi Food & Drug Authority), TITCK (Turkish Health Authorities)

REGIONE: Europa

USO: Umano, Veterinario

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

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

BSL (Livello di sicurezza biologica): 1, 2

Glatt Pharmaceutical Services GmbH Co. & KG
Germania

Glatt Pharmaceutical Services GmbH Co. & KG

Glatt Pharmaceutical Services GmbH Co. & KG

Il vostro CDMO conforme a cGMP per servizi end-to-end nel campo delle forme di dosaggio complesse dei solidi orali, con sede a Binzen in Germania.

DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande

AREE TERAPEUTICHE DI COMPETENZA (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (S) Sensory organs, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs, (V06) Nutrients

CATEGORIA / PRODOTTO: DFF / PRODOTTI MEDICINALI

COMPLIANCE: EMA (GMP UE), FDA (cGMP)

SOSTANZE CONTROLLATE: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse

REGIONE: Europa

USO: Umano, Veterinario

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

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

MERCATI: FDA (USA), EMA (EU)

BSL (Livello di sicurezza biologica): 1

Seda Pharma Development Services
Regno Unito

Seda Pharma Development Services

Seda Pharma Development Services Ltd

Seda Pharmaceutical Development Services è specializzata nello sviluppo farmaceutico integrato e nella farmacologia clinica.

MERCATI: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest of World, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

DIMENSIONE DEL LOTTO: Piccolo, Medio

CATEGORIA / PRODOTTO: DFF / PRODOTTI MEDICINALI

REGIONE: Europa

USO: Umano

COMPLIANCE: MHRA (UK GMP), ECOVADIS

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

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

AREE TERAPEUTICHE DI COMPETENZA (ATC): (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (B) Blood and blood forming organs

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

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

Seacross Pharmaceutical Co Ltd

Il sito di produzione della formulazione è dedicato allo sviluppo e alla produzione di forme di dosaggio complesse e di alto valore.

MERCATI: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest of World, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande

AREE TERAPEUTICHE DI COMPETENZA (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (V04) Diagnostic agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (B) Blood and blood forming organs, (V06) Nutrients

CATEGORIA / PRODOTTO: DFF / PRODOTTI MEDICINALI, SERVIZI

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

SOSTANZE CONTROLLATE: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse

BSL (Livello di sicurezza biologica): 3, 4, 1, 2

USO: Umano

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

REGIONE: APAC

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

STE PRASFARMA
Spagna

STE PRASFARMA

STE PRASFARMA

Citostatici CMO/CDMO e prodotti ad alta potenza.

MERCATI: Turkish Health Authorities, ANVISA (Brazil), EMA (EU), SFDA (Saudi Arabia), NMPA (China), MHRA (UK)

DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande

CATEGORIA / PRODOTTO: DFF / PRODOTTI MEDICINALI

COMPLIANCE: EMA (GMP UE), ANVISA (Brazil B-GMP), NMPA (Cina GMP), SFDA (Saudi Food & Drug Authority), ISO, TITCK (Turkish Health Authorities), ICH

REGIONE: Europa

BSL (Livello di sicurezza biologica): 3, 4

USO: Umano

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

SOSTANZE CONTROLLATE: High potential for abuse & medical use

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno)

AREE TERAPEUTICHE DI COMPETENZA (ATC): (L) Antineoplastic and immunomodulating agents

Limited view

DFF / PRODOTTI MEDICINALI manufacturing site

MAI network supplier

Soluzioni CDMO one-stop per APl e intermediari chiave.

Location available after registration

Limited view

DFF / PRODOTTI MEDICINALI manufacturing site

MAI network supplier

CDMO, attore chiave francese nello sviluppo di farmaci e nella fornitura di tecnologie orali al servizio delle industrie farmaceutiche e biologiche.

Location available after registration

Limited view

DFF / PRODOTTI MEDICINALI manufacturing site

MAI network supplier

Impianto Chimico-Farmaceutico

Location available after registration

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