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Laboratorio REIG JOFRE, SA (TOLEDO PLANT)
Spanien

Laboratorio REIG JOFRE, SA (TOLEDO PLANT)

LABORATORIO REIG JOFRE SA

Entwicklung und Herstellung von Betalactam-Antibiotika (FDF) in hochmodernen Anlagen.

MÄRKTE: EMA (EU), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), INVIMA (Colombia), SFDA (Saudi Arabia), TGA (Australia)

REGION: APAC, MENA, LATAM, Europe, North America

COMPLIANCE: DIGEMID, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP)

BATCH-GRÖSSE: Groß, Mittel

VERWENDUNG: Menschlich, Veterinär

BSL (Biologische Sicherheitsstufe): 1

DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

THERAPEUTISCHE FACHGEBIETE (ATC): (J) Antiinfectives for systemic use

KONTROLLIERTE SUBSTANZEN: Lowest potential for abuse

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS

SENN India | Non-GMP Plant | Hyderabad, India
Indien

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, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING

SENN India | R&D Lab | Hyderabad, India
Indien

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: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING

BATCH-GRÖSSE: Klein

Laboratorios Grifols | Barcelona Plant
Spanien

Laboratorios Grifols | Barcelona Plant

Grifols International

Sterile Herstellungslösungen (kleine Moleküle) in flexiblen Beuteln und Fläschchen.

MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)

DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGION: Europe

COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), ANMAT (Argentinien neue GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP)

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich, Veterinär

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism

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)

KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS

White Raven - Legiapark
Belgien

White Raven - Legiapark

White Raven

Abfüll- und Endbearbeitungsstandort für die GMP-Formulierung und die aseptische Abfüllung steriler flüssiger Injektionspräparate.

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: EMA (EU)

REGION: Europe

VERWENDUNG: Menschlich

BSL (Biologische Sicherheitsstufe): 1, 2

DIENSTLEISTUNGEN: Manufacturing services, Packaging

BATCH-GRÖSSE: Klein, Mittel

COMPLIANCE: EMA (EU-GMP)

KATEGORIE/PRODUKT: BIOLOGIEN, FDF / DRUG PRODUCTS

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
Spanien

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)

LABORATORIO REIG JOFRE SA

Produktionsanlagen für injizierbare (Lyo und Flüssigkeiten) und Flüssigkeiten.

BSL (Biologische Sicherheitsstufe): 3, 1, 2

MÄRKTE: EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MHRA (UK), INVIMA (Colombia), MFDS (South Korea), TGA (Australia)

REGION: Europe

BATCH-GRÖSSE: Groß, Mittel

VERWENDUNG: Menschlich, Veterinär

DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism

KONTROLLIERTE SUBSTANZEN: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

COMPLIANCE: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ECOVADIS, INVIMA, ISP (Chile BPM), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP)

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)

KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS

Sylentis
Spanien

Sylentis

Sylentis

Hersteller von Oligonukleotiden.

COMPLIANCE: ICH, FDA (cGMP), ISO, EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP)

MÄRKTE: EMA (EU), FDA (USA)

REGION: Europe

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich, Veterinär

KATEGORIE/PRODUKT: OLIGONUKLEOTIDE

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)

Upperton Pharma Solutions
Vereinigtes Königreich

Upperton Pharma Solutions

Upperton Pharma Solutions

Entwicklung und Herstellung oraler fester Dosen (OSD), nasaler, inhalativer und steriler Trockenpulver und flüssiger Arzneimittel.

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)

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), FDA (USA), Health Canada (Canada), MHRA (UK), TGA (Australia)

REGION: Europe

VERWENDUNG: Menschlich

KATEGORIE/PRODUKT: OLIGONUKLEOTIDE, BIOLOGIEN, SERVICES, FDF / DRUG PRODUCTS

BSL (Biologische Sicherheitsstufe): 1

DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (N) Nervous system, (R) Respiratory system

BATCH-GRÖSSE: Klein, Mittel

COMPLIANCE: MHRA (UK GMP)

VIVEbiotech
Spanien

VIVEbiotech

VIVEbiotech

Ihr führender GMP-zertifizierter CDMO, der sich ausschließlich der Produktion lentiviraler Vektoren widmet.

MÄRKTE: EMA (EU), FDA (USA), MHRA (UK)

REGION: Europe

COMPLIANCE: FDA (cGMP), Französischer Dienst - öffentlich (CIR), EMA (EU-GMP), MHRA (UK GMP)

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich

BSL (Biologische Sicherheitsstufe): 1, 2

DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

KATEGORIE/PRODUKT: BIOLOGIEN

Viswa Laboratories Pvt Ltd
Indien

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: CHEMICAL-SYNTHETIC

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)
China

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: CHEMICAL-SYNTHETIC

DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

Pharmaron API Commercial Synthesis Cramlington (UK)
Vereinigtes Königreich

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: Europe

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: CHEMICAL-SYNTHETIC

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)

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