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Cina
Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
Seacross Pharmaceutical Co Ltd
The R&D Center plays a fundamental role in supporting the development of both APIs and finished dosage forms.
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)
BSL (Livello di sicurezza biologica): 3, 4, 1, 2
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), 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: APAC
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), Health Canada, Servizio pubblico francese (CIR), PMDA (Giappone), MHRA (REGNO UNITO), NMPA (Cina GMP), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), TGA (Australia), ANVISA (Brasile), MFDS/KFDA (Repubblica di Corea GMP), SQF (alimenti di qualità sicuri), NSF
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano
CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC, FDF / DRUG PRODUCTS
Cina
Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site
Seacross Pharmaceutical Co Ltd
The Formulation Manufacturing Site is dedicated to the development and production of complex, high-value dosage forms.
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, (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)
BSL (Livello di sicurezza biologica): 3, 4, 1, 2
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), 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: APAC
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), Health Canada, Servizio pubblico francese (CIR), PMDA (Giappone), MHRA (REGNO UNITO), NMPA (Cina), NMPA (Cina GMP), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), TGA (Australia), ANVISA (Brasile), MFDS/KFDA (Repubblica di Corea GMP), SQF (alimenti di qualità sicuri), NSF
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano
CATEGORIA / PRODOTTO: SERVICES, FDF / DRUG PRODUCTS
Stati Uniti
Lifecore Injectables CDMO
Lifecore Biomedical
CDMO that manufactures clinical & commercial sterile injectable drug products.
BSL (Livello di sicurezza biologica): 3, 1, 2
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
COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), EMA (GMP UE), Health Canada (Canada GMP), MFDS/KFDA (Repubblica di Corea GMP)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano, Veterinario
SOSTANZE CONTROLLATE: Lowest potential for abuse
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)
REGIONE: North America
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
Spagna
PHARMALOOP S.L. - a Salvat Company
Laboratorios Salvat
Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multidose, non-sterile multi-dose, sachets, capsules and tablets.
MERCATI: EMA (EU), FDA (USA)
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ISO, EMA (GMP UE)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano
BSL (Livello di sicurezza biologica): 1
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
AREE TERAPEUTICHE DI COMPETENZA (ATC): (S) Sensory organs, (V01) Allergens
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
Svizzera
Ophtapharm, a Sentiss Company
Ophtapharm, a Sentiss Company
Ophtalmic and Otic - Solutions, suspensions, emulsions, ointments and gels - FDA Approved facility
MERCATI: EMA (EU), FDA (USA)
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ISO, EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano, Veterinario
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
Francia
Cenexi Hérouville Saint Clair
Cenexi
The Hérouville-Saint-Clair site, located near Caen, in Normandy, specializes in the manufacture and filling of injectable and non-injectable sterile liquids.
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), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea), TGA (Australia)
REGIONE: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), NMPA (Cina GMP), EMA (GMP UE), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP)
USO: Umano
SERVIZI: Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (N) Nervous system, (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
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
Spagna
Adragos Pharma | Halden
Adragos Pharma
Nos especializamos en la fabricación de bolsas intravenosas, ampollas y viales de plástico utilizando la tecnología Blow-Fill-Seal (BFS) y otras formas de dosif
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), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), TGA (Australia)
SERVIZI: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), 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
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, NUTRACEUTICI, OLIGONUCLEOTIDI, BIOLOGIA, SERVICES
USO: Umano
AREE TERAPEUTICHE DI COMPETENZA (ATC): (D) Dermatologicals, (L) Antineoplastic and immunomodulating agents, (V06) Nutrients, (A) Digestive tract and metabolism
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
Spagna
Adragos Pharma | Athens
Adragos Pharma
Socio global CDMO, ofreciendo servicios de Desarrollo y Fabricación para productos farmacéuticos.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
SOSTANZE CONTROLLATE: High potential for abuse & medical use
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: Europe
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
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, SERVICES
USO: Umano
Italia
Aenova Group - Location Latina, Italy
Aenova
Centro de Competencia de productos zoosanitarios y tecnologías estériles.
MERCATI: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (GMP UE)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGIA
USO: Umano, Veterinario
BSL (Livello di sicurezza biologica): 1, 2
AREE TERAPEUTICHE DI COMPETENZA (ATC): (L) Antineoplastic and immunomodulating agents, (P) Antiparasitic products, insecticides and repellents
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
REGIONE: Europe
CATEGORIA / PRODOTTO: OLIGONUCLEOTIDI, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, COSMETICI, SERVICES
USO: Umano
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ISO, EMA (GMP UE), Servizio pubblico francese (CIR), ECOVADIS, Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), NMPA (Cina GMP), TGA (Australia GMP), Roszdravnadzor (Russia GMP), ANMAT (nuove BPF dell'Argentina), MFDS/KFDA (Repubblica di Corea GMP), ISP (Chile BPM), INVIMA, MSPAS, COFEPRIS, DIGEMID, Health Canada (Canada GMP)
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Regulatory services, Packaging, Logistics, Quality Assurance services
DIMENSIONE DEL LOTTO: Piccolo, Grande, Medio
MERCATI: FDA (USA), EMA (EU), PMDA (Japan), ANVISA (Brazil), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), EDE (UAE)
AREE TERAPEUTICHE DI COMPETENZA (ATC): (D) Dermatologicals, (A) Digestive tract and metabolism, (C) Cardiovascular system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
Limited view
PARTICLE ENGINEERING manufacturing site
MAI network supplier
Soluciones para programas de administración no viral
Location available after registration
Limited view
SERVICES manufacturing site
MAI network supplier
Tubilux Pharma: registered office; manufacturing facility
Location available after registration
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