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Germania
Glatt Pharmaceutical Services GmbH Co. & KG
Glatt Pharmaceutical Services GmbH Co. & KG
Your cGMP-compliant CDMO for end-to-end services in the complex oral solids dosage forms field, based in Binzen Germany.
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: FDF / PRODOTTI FARMACEUTICI, SERVIZI, OLIGONUCLEOTIDI, INGEGNERIA DELLE PARTICELLE, CHIMICO-SINTETICO
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: Europe
USO: Umano, Veterinario
SERVIZI: Analytical / QC services, Manufacturing services, Development services
OEB (Occupational Exposure Banding): 2 (PDE = 1.000 - 5.000 µg/giorno), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
MERCATI: FDA (USA), EMA (EU)
BSL (Livello di sicurezza biologica): 1
Italia
Adare Pharma | US
Adare Pharma Solutions
Adare Pharma es un CDMO global con instalaciones en EE.UU. y la UE, que ofrece desarrollo de productos llave en mano mediante experiencia en fabricación comerci
MERCATI: DIGEMID (Peru), ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), 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
CATEGORIA / PRODOTTO: FDF / PRODOTTI FARMACEUTICI, SERVIZI, CHIMICO-SINTETICO
COMPLIANCE: EMA (GMP UE), PMDA/MHLW (Japan GMP), 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), NMPA (Cina GMP), ECOVADIS, ISO, Consiglio di ricerca halal, Health Canada (Canada GMP), TITCK (Turkish Health Authorities), MFDS/KFDA (Repubblica di Corea GMP)
REGIONE: Europe, North America
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 - 5.000 µg/giorno), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals
Italia
Adare Pharma | EU
Adare Pharma Solutions
Global CDMO offering turnkey product development through commercial manufacturing expertise, focused on oral dosage forms.
MERCATI: DIGEMID (Peru), ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), 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, (V01) Allergens, (M) Musculoskeletal system, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system
CATEGORIA / PRODOTTO: FDF / PRODOTTI FARMACEUTICI, SERVIZI, INGEGNERIA DELLE PARTICELLE, CHIMICO-SINTETICO
COMPLIANCE: EMA (GMP UE), PMDA/MHLW (Japan GMP), 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), NMPA (Cina GMP), ECOVADIS, ISO, Consiglio di ricerca halal, Health Canada (Canada GMP), TITCK (Turkish Health Authorities), MFDS/KFDA (Repubblica di Corea GMP)
REGIONE: Europe
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 - 5.000 µg/giorno), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
Regno Unito
Seda Pharma Development Services
Seda Pharma Development Services Ltd
Seda Pharmaceutical Development Services specialises in integrated Pharmaceutical Development and Clinical Pharmacology.
MERCATI: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), 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: FDF / PRODOTTI FARMACEUTICI, SERVIZI, CHIMICO-SINTETICO
REGIONE: Europe
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 - 5.000 µg/giorno), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 5,000 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
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.
MERCATI: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), 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, (V09-10) Radiopharmaceuticals, (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: FDF / PRODOTTI FARMACEUTICI, OLIGONUCLEOTIDI, INGEGNERIA DELLE PARTICELLE, CHIMICO-SINTETICO
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 - 5.000 µg/giorno), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
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.
MERCATI: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), 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: FDF / PRODOTTI FARMACEUTICI, SERVIZI, INGEGNERIA DELLE PARTICELLE, CHIMICO-SINTETICO
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 - 5.000 µg/giorno), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
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.
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
CATEGORIA / PRODOTTO: FDF / PRODOTTI FARMACEUTICI, SERVIZI, INGEGNERIA DELLE PARTICELLE, CHIMICO-SINTETICO
COMPLIANCE: EMA (GMP UE), FDA (cGMP), ISO
REGIONE: Europe
USO: Umano
SERVIZI: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
MERCATI: FDA (USA), EMA (EU)
AREE TERAPEUTICHE DI COMPETENZA (ATC): (V01) Allergens, (S) Sensory organs, (A) Digestive tract and metabolism
BSL (Livello di sicurezza biologica): 1
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
Francia
Cenexi SAS
Cenexi
Accueil Sites Osny. Acquired in 2011, the Osny site specializes in the development and production of highly active solid pharmaceutical forms.
DIMENSIONE DEL LOTTO: Piccolo, Medio
CATEGORIA / PRODOTTO: FDF / PRODOTTI FARMACEUTICI, SERVIZI, CHIMICO-SINTETICO
COMPLIANCE: EMA (GMP UE), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), MFDS/KFDA (Repubblica di Corea GMP)
REGIONE: Europe
MERCATI: ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), NMPA (China), MHRA (UK)
USO: Umano
SERVIZI: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
AREE TERAPEUTICHE DI COMPETENZA (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (G) Genito urinary system and sex hormones
OEB (Occupational Exposure Banding): 2 (PDE = 1.000 - 5.000 µg/giorno), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
Portorico
Sidefarma
Sidefarma SA
Sidefarma es un CMO especializado en la fabricación de lotes peque os y medianos para compa ías farmacéuticas de todo el mundo, en mercados regulados y siguiend
MERCATI: DIGEMID (Peru), Turkish Health Authorities, EDE (UAE), PMDA (Japan), EMA (EU), SFDA (Saudi Arabia), TGA (Australia), Health Canada (Canada), MHRA (UK)
DIMENSIONE DEL LOTTO: Piccolo, Medio
CATEGORIA / PRODOTTO: FDF / PRODOTTI FARMACEUTICI, SERVIZI, CHIMICO-SINTETICO
COMPLIANCE: EMA (GMP UE), UAE Ministry of Health & Prevention, ISO
SOSTANZE CONTROLLATE: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
REGIONE: Europe
USO: Umano
SERVIZI: Analytical / QC services, Manufacturing services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1.000 - 5.000 µg/giorno), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
Germania
Aenova Group - Location Gronau, Germany
Aenova
Centro de competencia para sólidos convencionales y servicios clínicos.
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
CATEGORIA / PRODOTTO: FDF / PRODOTTI FARMACEUTICI, SERVIZI, BIOLOGIA, CHIMICO-SINTETICO
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (GMP UE), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), FDA (cGMP)
MERCATI: EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU)
REGIONE: Europe
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 - 5.000 µg/giorno), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
AREE TERAPEUTICHE DI COMPETENZA (ATC): (L) Antineoplastic and immunomodulating agents
Germania
Aenova Group - Location Killorglin, Ireland
Aenova
Centro de Competencia para secado por atomización (spray drying) y pellets de liberación modificada.
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
CATEGORIA / PRODOTTO: FDF / PRODOTTI FARMACEUTICI, INGEGNERIA DELLE PARTICELLE, NUTRACEUTICI, CHIMICO-SINTETICO
COMPLIANCE: EMA (GMP UE), PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), ISO, MFDS/KFDA (Repubblica di Corea GMP)
REGIONE: Europe
USO: Umano, Veterinario
SERVIZI: Analytical / QC services, Manufacturing services, Development services, Packaging, Quality Assurance services
MERCATI: PMDA (Japan), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia)
OEB (Occupational Exposure Banding): 2 (PDE = 1.000 - 5.000 µg/giorno), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
Germania
Aenova Group - Location Marburg, Germany
Aenova
Centro de competencia sólidos convencionales complejos y estupefacientes.
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
CATEGORIA / PRODOTTO: FDF / PRODOTTI FARMACEUTICI, INGEGNERIA DELLE PARTICELLE, NUTRACEUTICI, CHIMICO-SINTETICO
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (GMP UE), ANVISA (Brazil B-GMP), FDA (cGMP)
REGIONE: Europe
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 - 5.000 µg/giorno), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
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