Aenova Group - Location Marburg, Germany

Aenova Group - Location Marburg, Germany

Competence Center complex conventional solids and narcotics.

About the plant

The Aenova site in Marburg has special expertise in the production and packaging of moisture-sensitive dosage forms and solid dosage forms.

The Aenova site in Marburg can look back on a history of over one hundred years of pharmaceutical production.

The site processes organic solvents (granulation, drying and coating), handles narcotic substances and manufactures complex immediate and sustained release pellets with small and medium API loadings (non pareil seeds).

More information here: Aenova Group

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Certifications

• EMA (EU GMP)
• FDA (cGMP)
• ANVISA (Brazil B-GMP)
• Roszdravnadzor (Russia GMP)

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Activity

• Oral solids / OSD, Tablets, Hard capsules, Granules / Pellets, Powders, Lozenges, FDF / DRUG PRODUCTS, NUTRACEUTICALS, Blister packs, Bottles: Plastic, Bottles: Glass, Tubes manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
• DEA: N/A
• BSL:
• Therapeutic areas: N/A
• Markets: FDA (USA), EMA (EU), ANVISA (Brazil), Russian Health Authorities

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Tech transfer, Primary packaging, Secondary packaging, Labeling, Serialization

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