SENN India | Non-GMP Plant | Hyderabad, India
Senn Chemicals
Sito di produzione non GMP su larga scala per intermedi peptidici, sintesi organica, operazioni LPPS e produzione su larga scala.
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: APAC
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
CATEGORIA / PRODOTTO: COSMETICI, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING
SENN India | R&D Lab | Hyderabad, India
Senn Chemicals
Centro di ricerca e sviluppo per la chimica organica e dei peptidi con supporto per SPPS, purificazione, liofilizzazione, analisi e ingegneria delle particelle.
SERVIZI: Logistics, Development services, Analytical / QC services, Quality Assurance services, Packaging
REGIONE: APAC
CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING
DIMENSIONE DEL LOTTO: Piccolo
Laboratorios Grifols | Barcelona Plant
Grifols International
Soluzioni di produzione sterili (piccole molecole) in buste flessibili e fiale.
MERCATI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), 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, Veterinario
AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism
SOSTANZE CONTROLLATE: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
OEB (Occupational Exposure Banding): 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: FDF / DRUG PRODUCTS
White Raven - Legiapark
White Raven
Sito di riempimento e finitura dedicato alla formulazione GMP e al riempimento asettico di liquidi iniettabili 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)
REGIONE: Europe
USO: Umano
BSL (Livello di sicurezza biologica): 1, 2
SERVIZI: Manufacturing services, Packaging
DIMENSIONE DEL LOTTO: Piccolo, Medio
COMPLIANCE: EMA (GMP UE)
CATEGORIA / PRODOTTO: BIOLOGIA, FDF / DRUG PRODUCTS
COMPLIANCE: ICH, FDA (cGMP), ISO, EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP)
MERCATI: EMA (EU), FDA (USA)
REGIONE: Europe
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano, Veterinario
CATEGORIA / PRODOTTO: OLIGONUCLEOTIDI
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
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)
Upperton Pharma Solutions
Upperton Pharma Solutions
Sviluppo e produzione di prodotti farmaceutici liquidi a dose solida orale (OSD), nasali, per inalazione e sterili in polvere secca e liquida.
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), FDA (USA), Health Canada (Canada), MHRA (UK), TGA (Australia)
REGIONE: Europe
USO: Umano
CATEGORIA / PRODOTTO: OLIGONUCLEOTIDI, BIOLOGIA, SERVICES, FDF / DRUG PRODUCTS
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): (C) Cardiovascular system, (N) Nervous system, (R) Respiratory system
DIMENSIONE DEL LOTTO: Piccolo, Medio
COMPLIANCE: MHRA (UK GMP)
VIVEbiotech
VIVEbiotech
Il vostro CDMO leader certificato GMP dedicato esclusivamente alla produzione di vettori lentivirali.
MERCATI: EMA (EU), FDA (USA), MHRA (UK)
REGIONE: Europe
COMPLIANCE: FDA (cGMP), Servizio pubblico francese (CIR), EMA (GMP UE), MHRA (UK GMP)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano
BSL (Livello di sicurezza biologica): 1, 2
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
CATEGORIA / PRODOTTO: BIOLOGIA
Viswa Laboratories Pvt Ltd
Viswa Laboratories Private Limited
CRAMS/CDMO, API, intermedi e prodotti chimici speciali.
MERCATI: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, CDSCO (India)
REGIONE: APAC
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano, Veterinario
BSL (Livello di sicurezza biologica): 1, 2
CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC
SERVIZI: Development services, Manufacturing services
AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (R) Respiratory system
SOSTANZE CONTROLLATE: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
COMPLIANCE: Organizzazione Mondiale della Sanità (GMP / HACCP)
Pharmaron API Commercial Synthesis Shaoxing (China)
Pharmaron
Sintesi di piccole molecole/peptidi API commerciali.
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: NMPA (China), FDA (USA)
REGIONE: APAC
COMPLIANCE: FDA (cGMP), ISO, NMPA (Cina GMP)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano, Veterinario
CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
Pharmaron API Commercial Synthesis Cramlington (UK)
Pharmaron
Sintesi di piccole molecole API commerciali.
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
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), MHRA (UK), MFDS (South Korea), TGA (Australia)
REGIONE: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), EMA (GMP UE), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano, Veterinario
CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
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)
Pharmaron API Commercial Synthesis Coventry (US)
Pharmaron
Sintesi di piccole molecole API commerciali.
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
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), FDA (USA), Health Canada (Canada), MHRA (UK), MFDS (South Korea), TGA (Australia)
COMPLIANCE: FDA (cGMP), ISO, ECOVADIS
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano, Veterinario
CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC
SERVIZI: Development services, Manufacturing services
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
HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
Capacità interne end-to-end dallo sviluppo della linea cellulare alla produzione commerciale.
MERCATI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europe
COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano, Veterinario
BSL (Livello di sicurezza biologica): 1, 2
OEB (Occupational Exposure Banding): 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: BIOLOGIA, FDF / DRUG PRODUCTS
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