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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Eine von der USFDA zugelassene API- und Intermediate-Produktionsanlage.

Location available after registration

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FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Chemisch-pharmazeutische Anlage

Location available after registration

Suggested Results

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Avara Pharmaceutical Services | Arecibo Site
Vereinigte Staaten

Avara Pharmaceutical Services | Arecibo Site

AVARA

Kommerzielle Produktionsanlage für orale feste Dosierungen (OSD) mit ausgeprägter Expertise im Bereich kontrollierter Substanzen (DEA II V).

BATCH-GRÖSSE: Mittel, Groß

THERAPEUTISCHE FACHGEBIETE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs

KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC

COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU-GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), Gesundheit Kanada (Kanada GMP), MFDS/KFDA (Republik Korea GMP), ICH

KONTROLLIERTE SUBSTANZEN: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse

MÄRKTE: ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada)

VERWENDUNG: Menschlich

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

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

REGION: North America

Avara Pharmaceutical Services | Norman Site
Vereinigte Staaten

Avara Pharmaceutical Services | Norman Site

AVARA

Auftragsfertigungsanlage, spezialisiert auf orale feste Dosierung (OSD) für die klinische und kommerzielle Versorgung.

BATCH-GRÖSSE: Klein, Mittel, Groß

THERAPEUTISCHE FACHGEBIETE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs

KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC

COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU-GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), Gesundheit Kanada (Kanada GMP), MFDS/KFDA (Republik Korea GMP), ICH

KONTROLLIERTE SUBSTANZEN: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse

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

VERWENDUNG: Menschlich

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

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

REGION: North America

TRADICHEM INDUSTRIAL SERVICES
Spanien

TRADICHEM INDUSTRIAL SERVICES

TRADICHEM INDUSTRIAL SERVICES S.L.

HIPERING® TECHNOLOGY – DAS TOR FÜR LEAN MANUFACTURING

BATCH-GRÖSSE: Klein, Mittel, Groß

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

KATEGORIE/PRODUKT: SERVICES, PARTICLE ENGINEERING, NUTRAZEUTIKA

REGION: Europe

VERWENDUNG: Menschlich, Veterinär

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

DIENSTLEISTUNGEN: Manufacturing services, Development services

MÄRKTE: FDA (USA), EMA (EU)

BSL (Biologische Sicherheitsstufe): 1, 2

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Trockenpulver-Inhalationsanlage.

Location available after registration

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

F&E und analytische Dienstleistungen, Technologietransfer und Einführung neuer Produkte sowie Herstellung fester und flüssiger oraler Darreichungsformen.

Location available after registration

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Ihr vertrauenswürdiger GMP-CDMO für fortschrittliche aseptische und nicht-aseptische Herstellung pharmazeutischer Arzneimittel, Formulierungsentwicklung und ana

Location available after registration