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SENN Chemicals | R&D and Kilo Lab | Dielsdorf, Switzerland
Senn Chemicals
Schweizer Forschungs- und Entwicklungsstandort für Peptide und Peptidzwischenprodukte mit SPPS, LPPS, Hybridsynthese, Maßstabsvergrößerung im Kilolabor, Reinigu
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europa
KATEGORIE/PRODUKT: KOSMETIK, CHEMISCH-SYNTHETISCH, DIENSTLEISTUNGEN, PARTIKELTECHNIK
BATCH-GRÖSSE: Klein
SENN Chemicals | Small Scale GMP Lab | Dielsdorf, Switzerland
Senn Chemicals
Kleines GMP-Peptid- und organisches Syntheselabor für klinische, Nischen- und hochwertige Projekte, die eine flexible cGMP-Produktion erfordern.
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europa
KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH, PARTIKELTECHNIK
BATCH-GRÖSSE: Klein
SENN Chemicals | GMP Production | Dielsdorf, Switzerland
Senn Chemicals
Schweizer cGMP-Produktionsstandort für die Herstellung von LPPS, SPPS und Hybridpeptiden vom Pilot- bis zum frühen kommerziellen Maßstab.
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europa
BATCH-GRÖSSE: Groß, Mittel
KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH, PARTIKELTECHNIK
SENN India | Non-GMP Plant | Hyderabad, India
Senn Chemicals
Groß angelegter Nicht-GMP-Produktionsstandort für Peptid-Zwischenprodukte, organische Synthese, LPPS-Betriebe und Scale-up-Produktion.
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: APAC
BATCH-GRÖSSE: Groß, Klein, Mittel
KATEGORIE/PRODUKT: KOSMETIK, CHEMISCH-SYNTHETISCH, DIENSTLEISTUNGEN, PARTIKELTECHNIK
SENN India | R&D Lab | Hyderabad, India
Senn Chemicals
Forschungs- und Entwicklungszentrum für Peptid- und organische Chemie mit Unterstützung für SPPS, Reinigung, Lyophilisierung, Analytik und Partikeltechnik.
DIENSTLEISTUNGEN: Logistics, Development services, Analytical / QC services, Quality Assurance services, Packaging
REGION: APAC
KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH, PARTIKELTECHNIK
BATCH-GRÖSSE: Klein
Viswa Laboratories Pvt Ltd
Viswa Laboratories Private Limited
CRAMS/CDMO, APIs, Zwischenprodukte und Spezialchemikalien.
MÄRKTE: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, CDSCO (India)
REGION: APAC
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich, Veterinär
BSL (Biologische Sicherheitsstufe): 1, 2
KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH
DIENSTLEISTUNGEN: Development services, Manufacturing services
THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (R) Respiratory system
KONTROLLIERTE SUBSTANZEN: 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/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
COMPLIANCE: Weltgesundheitsorganisation (GMP / HACCP)
Pharmaron API Commercial Synthesis Shaoxing (China)
Pharmaron
Kommerzielle API-Synthese kleiner Moleküle/Peptide.
THERAPEUTISCHE FACHGEBIETE (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/Tag), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
MÄRKTE: NMPA (China), FDA (USA)
REGION: APAC
COMPLIANCE: FDA (cGMP), ISO, NMPA (China GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich, Veterinär
KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
Pharmaron API Commercial Synthesis Cramlington (UK)
Pharmaron
Kommerzielle API-Synthese kleiner Moleküle.
THERAPEUTISCHE FACHGEBIETE (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
KONTROLLIERTE SUBSTANZEN: 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
MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), TGA (Australia)
REGION: Europa
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich, Veterinär
KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/Tag), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
Pharmaron API Commercial Synthesis Coventry (US)
Pharmaron
Kommerzielle API-Synthese kleiner Moleküle.
THERAPEUTISCHE FACHGEBIETE (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
KONTROLLIERTE SUBSTANZEN: 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
MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), MFDS (South Korea), TGA (Australia)
COMPLIANCE: FDA (cGMP), ISO, ECOVADIS
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich, Veterinär
KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH
DIENSTLEISTUNGEN: Development services, Manufacturing services
OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/Tag), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
REGION: Nordamerika
Avara Pharmaceutical Services | Arecibo Site
AVARA
Kommerzielle Produktionsanlage für orale feste Dosierungen (OSD) mit ausgeprägter Expertise im Bereich kontrollierter Substanzen (DEA II V).
KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
COMPLIANCE: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), MFDS/KFDA (Republik Korea GMP)
MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), TGA (Australia)
BATCH-GRÖSSE: Groß, Mittel
VERWENDUNG: Menschlich
KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH, DIENSTLEISTUNGEN, FDF / Arzneimittelprodukte, PARTIKELTECHNIK
DIENSTLEISTUNGEN: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (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, (R) Respiratory system, (S) Sensory organs, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
REGION: Nordamerika
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
Avara Pharmaceutical Services | Norman Site
AVARA
Auftragsfertigungsanlage, spezialisiert auf orale feste Dosierung (OSD) für die klinische und kommerzielle Versorgung.
KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
COMPLIANCE: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP)
MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea), TGA (Australia)
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich
KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH, DIENSTLEISTUNGEN, FDF / Arzneimittelprodukte, PARTIKELTECHNIK
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (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, (R) Respiratory system, (S) Sensory organs, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
REGION: Nordamerika
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
Indena Settala
Indena
GMP-konforme und von der FDA geprüfte Anlage, die auf komplexe Wirkstoffe und hochwirksame Verbindungen bis OEB 6 spezialisiert ist.
MÄRKTE: 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)
BATCH-GRÖSSE: Klein, Mittel, Groß
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/Tag)
COMPLIANCE: NMPA (China GMP), EMA (EU-GMP), MFDS/KFDA (Republik Korea GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP)
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europa
VERWENDUNG: Menschlich, Veterinär
KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH
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