
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.
Markets: Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), TGA (Australia), Resto del mondo
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1, 2, 3, 4
Compliance: ISO, FDA (cGMP), DIGEMID, BRCGS, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, TGA (Australia GMP), TITCK (Turkish Health Authorities), INVIMA, ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), World Health Organization (GMP / HACCP), NMPA (China GMP), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, SQF (Safe Quality Food), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (B) Blood and blood forming organs, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (S) Sensory organs, (V06) Nutrients, (V01) Allergens, (R) Respiratory system, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (H) Systemic hormonal preparations excl. sex hormones and insulins, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS, SERVICES
Region: APAC

Aenova
Centro di Competenza prodotti per la sanità animale e tecnologie sterili.
Markets: ANVISA (Brazil), FDA (USA), EMA (EU), Russian Health Authorities, Turkish Health Authorities, SFDA (Saudi Arabia)
Batch Size: Large, Small, Medium
Use: Human, Veterinary
BSL (Biological Safety Level): 1, 2
Compliance: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (EU GMP), SFDA (Saudi Food & Drug Authority)
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
Region: Europe

Seacross Pharmaceutical Co Ltd
Il Centro R&D svolge un ruolo fondamentale nel supportare lo sviluppo sia degli API che delle forme di dosaggio finite.
Markets: Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), TGA (Australia), Resto del mondo
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1, 2, 3, 4
Compliance: ISO, FDA (cGMP), DIGEMID, BRCGS, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, TGA (Australia GMP), TITCK (Turkish Health Authorities), INVIMA, ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), World Health Organization (GMP / HACCP), NMPA (China GMP), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, SQF (Safe Quality Food), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (S) Sensory organs, (V06) Nutrients, (V01) Allergens, (R) Respiratory system, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (H) Systemic hormonal preparations excl. sex hormones and insulins, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC
Region: APAC

JAFRAL
Struttura biotecnologica integrata che fornisce ricerca e sviluppo, produzione non GMP e GMP, test di controllo qualità e servizi di riempimento e finitura per prodotti biologici avanzati.
Markets: Health Canada (Canada), ANVISA (Brazil), FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK), CDSCO (India), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), TGA (Australia)
Category / Product: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Batch Size: Large, Small, Medium
Use: Human, Veterinary
BSL (Biological Safety Level): 1, 2
Compliance: ISO, ICH, FDA (cGMP), World Health Organization (GMP / HACCP), EMA (EU GMP), SQF (Safe Quality Food)
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Controlled Substances: Lowest potential for abuse
Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (V06) Nutrients, (R) Respiratory system, (A) Digestive tract and metabolism
Region: Europe

Adragos Pharma
È specializzato nello sviluppo di farmaci a valore aggiunto ed è stato recentemente aggiornato con funzionalità HPAPI.
Markets: Health Canada (Canada), ANVISA (Brazil), FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), CDSCO (India), EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)
Batch Size: Large, Small, Medium
Use: Human
Compliance: ISO, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), NMPA (China GMP), MHRA (UK GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, UAE Ministry of Health & Prevention
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse, High potential for abuse & medical use
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS, SERVICES
Region: Europe

Adragos Pharma
Siamo specializzati nella produzione di sacche per flebo, fiale e fiale di plastica utilizzando la tecnologia Blow-Fill-Seal (BFS) e altre forme di dosaggio.
Batch Size: Large, Small, Medium
Use: Human
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), TGA (Australia)
Services: Logistics, Analytical / QC services, Regulatory services, Packaging, Manufacturing services, Quality Assurance services
Compliance: ISO, FDA (cGMP), ANVISA (Brazil B-GMP), PMDA/MHLW (Japan GMP), TITCK (Turkish Health Authorities), TGA (Australia GMP), NMPA (China GMP), MHRA (UK GMP), World Health Organization (GMP / HACCP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, UAE Ministry of Health & Prevention
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse, High potential for abuse & medical use
Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (V06) Nutrients, (A) Digestive tract and metabolism
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
Region: Europe

Lifecore Biomedical
CDMO che produce prodotti farmaceutici iniettabili sterili clinici e commerciali.
Batch Size: Large, Small, Medium
Use: Human, Veterinary
BSL (Biological Safety Level): 1, 2, 3
Compliance: ISO, FDA (cGMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), ECOVADIS, EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia), Resto del mondo
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Controlled Substances: Lowest potential for abuse
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
Region: North America

Cenexi
Il sito di Hérouville-Saint-Clair, situato vicino a Caen, in Normandia, è specializzato nella produzione e nel riempimento di liquidi sterili iniettabili e non
Use: Human
Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), NMPA (China GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), ANVISA (Brazil), MHRA (UK), Russian Health Authorities, MFDS (South Korea), TGA (Australia)
Services: Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (C) Cardiovascular system, (A) Digestive tract and metabolism
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use
Batch Size: Small, Medium
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
Region: Europe

Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Markets: 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), MFDS (South Korea), EDE (UAE), TGA (Australia)
Compliance: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
Use: Human
Batch Size: Large, Small, Medium
Therapeutic Areas of Expertise (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (D) Dermatologicals, (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Category / Product: FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
Region: Europe

Hbm Pharma
CMO certificato EU-GMP con sede a Martin, Slovacchia. L'azienda fornisce servizi di produzione e confezionamento di prodotti farmaceutici sterili. prodotti e forme di dosaggio solide orali
Markets: EMA (EU), NMPA (China), Health Canada (Canada), ANVISA (Brazil), COFEPRIS (Mexico), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, TGA (Australia)
Compliance: ISO, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), ANVISA (Brazil)
Use: Human
Batch Size: Large, Small, Medium
Services: Analytical / QC services, Packaging, Quality Assurance services, Manufacturing services
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Controlled Substances: High potential for abuse & medical use
Category / Product: FDF / DRUG PRODUCTS, SERVICES
Region: Europe

Laboratorios Salvat
Soluzioni CDMO completamente integrate per Blow-Fill-Seal (BFS), multidose sterile, multidose non sterile, bustine, capsule e compresse.
Markets: EMA (EU), FDA (USA)
Region: Europe
Compliance: FDA (cGMP), ISO, EMA (EU GMP)
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (S) Sensory organs, (V01) Allergens
Category / Product: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
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