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Deutschland

Glatt Pharmaceutical Services GmbH Co. & KG

Your cGMP-compliant CDMO for end-to-end services in the complex oral solids dosage forms field, based in Binzen Germany.

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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)

REGION: Europe

COMPLIANCE: FDA (cGMP), EMA (EU-GMP)

BATCH-GRÖSSE: Groß, Klein, Mittel

KATEGORIE/PRODUKT: FDF/DROGENPRODUKTE, CHEMISCH-SYNTHETISCH, OLIGONUKLEOTIDE, DIENSTLEISTUNGEN, PARTIKELTECHNIK

VERWENDUNG: Menschlich, Veterinär

BSL (Biologische Sicherheitsstufe): 1

DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services

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, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/Tag), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1.000 - 5.000 µg/Tag), 3 (PDE = 100 - 1.000 µg/Tag)

Italien

Adare Pharma | US

Adare Pharma Solutions

Adare Pharma es un CDMO global con instalaciones en EE.UU. y la UE, que ofrece desarrollo de productos llave en mano mediante experiencia en fabricación comerci

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COMPLIANCE: UAE Ministry of Health & Prevention, Französischer Dienst - öffentlich (CIR), NMPA (China GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Halal-Forschungsrat, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities)

MÄRKTE: SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), TGA (Australia), 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)

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1.000 - 5.000 µg/Tag), 3 (PDE = 100 - 1.000 µg/Tag), 4 / HPAPI (PDE = 10 - 100 µg/Tag)

THERAPEUTISCHE FACHGEBIETE (ATC): (A) Digestive tract and metabolism, (C) Cardiovascular system, (D) Dermatologicals

REGION: North America, Europe

BATCH-GRÖSSE: Klein, Mittel, Groß

KATEGORIE/PRODUKT: DIENSTLEISTUNGEN, FDF/DROGENPRODUKTE, CHEMISCH-SYNTHETISCH

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

VERWENDUNG: Menschlich, Veterinär

Italien

Adare Pharma | EU

Adare Pharma Solutions

Global CDMO offering turnkey product development through commercial manufacturing expertise, focused on oral dosage forms.

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MÄRKTE: 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), EDE (UAE), TGA (Australia)

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

REGION: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Halal-Forschungsrat, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, Französischer Dienst - öffentlich (CIR), NMPA (China GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP)

BATCH-GRÖSSE: Groß, Klein, Mittel

KATEGORIE/PRODUKT: FDF/DROGENPRODUKTE, CHEMISCH-SYNTHETISCH, DIENSTLEISTUNGEN, PARTIKELTECHNIK

VERWENDUNG: Menschlich, Veterinär

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V01) Allergens, (A) Digestive tract and metabolism

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/Tag), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1.000 - 5.000 µg/Tag), 3 (PDE = 100 - 1.000 µg/Tag)

Vereinigtes Königreich

Seda Pharma Development Services

Seda Pharma Development Services Ltd

Seda Pharmaceutical Development Services specialises in integrated Pharmaceutical Development and Clinical Pharmacology.

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OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/Tag), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1.000 - 5.000 µg/Tag), 3 (PDE = 100 - 1.000 µg/Tag)

REGION: Europe

KATEGORIE/PRODUKT: FDF/DROGENPRODUKTE, CHEMISCH-SYNTHETISCH, DIENSTLEISTUNGEN

VERWENDUNG: Menschlich

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

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

COMPLIANCE: ECOVADIS, MHRA (UK GMP)

BATCH-GRÖSSE: Klein, Mittel

China

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site

Seacross Pharmaceutical Co Ltd

The R&D Center plays a fundamental role in supporting the development of both APIs and finished dosage forms.

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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

BSL (Biologische Sicherheitsstufe): 3, 4, 1, 2

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

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

REGION: APAC

COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal-Forschungsrat, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), Französischer Dienst - öffentlich (CIR), NMPA (China GMP), ANMAT (Argentinien neue GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP), SQF (Sichere Lebensmittelqualität), NSF

BATCH-GRÖSSE: Groß, Klein, Mittel

KATEGORIE/PRODUKT: FDF/DROGENPRODUKTE, CHEMISCH-SYNTHETISCH, OLIGONUKLEOTIDE, PARTIKELTECHNIK

VERWENDUNG: Menschlich

China

Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site

Seacross Pharmaceutical Co Ltd

The Formulation Manufacturing Site is dedicated to the development and production of complex, high-value dosage forms.

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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

BSL (Biologische Sicherheitsstufe): 3, 4, 1, 2

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

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

REGION: APAC

BATCH-GRÖSSE: Groß, Klein, Mittel

KATEGORIE/PRODUKT: FDF/DROGENPRODUKTE, CHEMISCH-SYNTHETISCH, DIENSTLEISTUNGEN, PARTIKELTECHNIK

VERWENDUNG: Menschlich

Deutschland

Green Phoenix Labs GmbH

Cell Therapy company with excess Cleanroom capacity

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MÄRKTE: EMA (EU)

DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging

REGION: Europe

KATEGORIE/PRODUKT: FDF/DROGENPRODUKTE, CHEMISCH-SYNTHETISCH, BIOLOGIEN, DIENSTLEISTUNGEN

VERWENDUNG: Menschlich

BSL (Biologische Sicherheitsstufe): 1

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

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

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1.000 - 5.000 µg/Tag), 3 (PDE = 100 - 1.000 µg/Tag)

BATCH-GRÖSSE: Klein, Mittel

COMPLIANCE: EMA (EU-GMP)

Spanien

Laboratorio REIG JOFRE, SA (TOLEDO PLANTS)

LABORATORIO REIG JOFRE SA

Betalactam antibiotics (FDF) development and manufacturing state-of-the-art facilities.

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

REGION: Europe

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

KATEGORIE/PRODUKT: FDF/DROGENPRODUKTE, CHEMISCH-SYNTHETISCH

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): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1.000 - 5.000 µg/Tag)

Spanien

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)

LABORATORIO REIG JOFRE SA

Injectable (lyo and liquid) and Liquid manufacturing facilities.

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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

KATEGORIE/PRODUKT: FDF/DROGENPRODUKTE, CHEMISCH-SYNTHETISCH

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): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1.000 - 5.000 µg/Tag), 3 (PDE = 100 - 1.000 µg/Tag)

Schweiz

Ophtapharm, a Sentiss Company

Ophtalmic and Otic - Solutions, suspensions, emulsions, ointments and gels - FDA Approved facility

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MÄRKTE: EMA (EU), FDA (USA)

REGION: Europe

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

BATCH-GRÖSSE: Groß, Klein, Mittel

KATEGORIE/PRODUKT: FDF/DROGENPRODUKTE, CHEMISCH-SYNTHETISCH, DIENSTLEISTUNGEN

VERWENDUNG: Menschlich, Veterinär

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

THERAPEUTISCHE FACHGEBIETE (ATC): (P) Antiparasitic products, insecticides and repellents

Spanien

PHARMALOOP S.L. - a Salvat Company

Laboratorios Salvat

Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multidose, non-sterile multi-dose, sachets, capsules and tablets.

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MÄRKTE: EMA (EU), FDA (USA)

REGION: Europe

COMPLIANCE: FDA (cGMP), ISO, EMA (EU-GMP)

BATCH-GRÖSSE: Groß, Klein, Mittel

KATEGORIE/PRODUKT: FDF/DROGENPRODUKTE, CHEMISCH-SYNTHETISCH, DIENSTLEISTUNGEN, PARTIKELTECHNIK

VERWENDUNG: Menschlich

BSL (Biologische Sicherheitsstufe): 1

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

THERAPEUTISCHE FACHGEBIETE (ATC): (S) Sensory organs, (V01) Allergens, (A) Digestive tract and metabolism

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)

Vereinigte Staaten

Lifecore Injectables CDMO

Lifecore Biomedical

CDMO that manufactures clinical & commercial sterile injectable drug products.

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BSL (Biologische Sicherheitsstufe): 3, 1, 2

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

COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), MFDS/KFDA (Republik Korea GMP)

BATCH-GRÖSSE: Groß, Klein, Mittel

KATEGORIE/PRODUKT: FDF/DROGENPRODUKTE, CHEMISCH-SYNTHETISCH, BIOLOGIEN, DIENSTLEISTUNGEN

VERWENDUNG: Menschlich, Veterinär

THERAPEUTISCHE FACHGEBIETE (ATC): (L) Antineoplastic and immunomodulating agents

KONTROLLIERTE SUBSTANZEN: Lowest potential for abuse

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/Tag), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1.000 - 5.000 µg/Tag), 3 (PDE = 100 - 1.000 µg/Tag)

REGION: North America

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