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SENN Chemicals | R&D and Kilo Lab | Dielsdorf, Switzerland
Senn Chemicals
Sito svizzero di ricerca e sviluppo su peptidi e intermedi peptidici con SPPS, LPPS, sintesi ibrida, scale up in laboratorio, purificazione e analisi.
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europa
CATEGORIA / PRODOTTO: COSMETICI, CHIMICO-SINTETICO, SERVIZI, INGEGNERIA DELLE PARTICELLE
DIMENSIONE DEL LOTTO: Piccolo
SENN Chemicals | Small Scale GMP Lab | Dielsdorf, Switzerland
Senn Chemicals
Laboratorio di sintesi organica e di peptidi GMP su piccola scala per progetti clinici, di nicchia e di alto valore che richiedono una produzione flessibile di
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europa
CATEGORIA / PRODOTTO: CHIMICO-SINTETICO, INGEGNERIA DELLE PARTICELLE
DIMENSIONE DEL LOTTO: Piccolo
SENN Chemicals | GMP Production | Dielsdorf, Switzerland
Senn Chemicals
Sito svizzero di produzione cGMP per la produzione di LPPS, SPPS e peptidi ibridi dal progetto pilota alla prima scala commerciale.
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europa
DIMENSIONE DEL LOTTO: Grande, Medio
CATEGORIA / PRODOTTO: CHIMICO-SINTETICO, INGEGNERIA DELLE PARTICELLE
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, CHIMICO-SINTETICO, SERVIZI, INGEGNERIA DELLE PARTICELLE
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: CHIMICO-SINTETICO
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: CHIMICO-SINTETICO
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: Europa
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: CHIMICO-SINTETICO
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: CHIMICO-SINTETICO
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: America del Nord
Indena Settala
Indena
Struttura conforme alle GMP e ispezionata dalla FDA, specializzata in API complessi e composti ad alta potenza fino a OEB 6.
MERCATI: TGA (Australia), Rest of World, 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)
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
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), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno)
COMPLIANCE: NMPA (Cina GMP), EMA (GMP UE), MFDS/KFDA (Repubblica di Corea GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP)
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europa
USO: Umano, Veterinario
CATEGORIA / PRODOTTO: CHIMICO-SINTETICO
Hikal Ltd | Bangalore, India
Hikal Ltd.
Sviluppo di processi cGMP, scale-up e produzione di API di piccole molecole, NME e intermedi da grammi a toni.
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), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), 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
REGIONE: APAC
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), COFEPRIS, Consiglio di ricerca halal, ECOVADIS, TGA (Australia GMP), EMA (GMP UE)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
CATEGORIA / PRODOTTO: COSMETICI, NUTRACEUTICI, CHIMICO-SINTETICO, SERVIZI
USO: Umano, Veterinario
SERVIZI: Development services, Manufacturing services
AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (V06) Nutrients
CARBOGEN AMCIS | Vionnaz
CARBOGEN AMCIS
Sviluppo di API altamente potenti e produzione cGMP su piccola scala, tra cui cromatografia e liofilizzazione.
MERCATI: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)
REGIONE: Europa
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP)
USO: Umano, Veterinario
CATEGORIA / PRODOTTO: CHIMICO-SINTETICO
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance 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)
DIMENSIONE DEL LOTTO: Piccolo
CARBOGEN AMCIS | Veenendaal
CARBOGEN AMCIS
Produzione su larga scala di analoghi del colesterolo e della vitamina D.
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: 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: Europa
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), Servizio pubblico francese (CIR), NMPA (Cina GMP), 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), SQF (alimenti di qualità sicuri), NSF
USO: Umano, Veterinario
BSL (Livello di sicurezza biologica): 1
CATEGORIA / PRODOTTO: CHIMICO-SINTETICO, SERVIZI
DIMENSIONE DEL LOTTO: Piccolo
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