Aenova Group - Location Gronau, Germany

Aenova Group - Location Gronau, Germany

Competence center for conventional solids and clinical services.

About the plant

The Aenova site in Gronau has special expertise in the development, production and packaging of tablets, and is specialized in packaging and distribution of clinical trial material.

The site can look back on more than 100 years of history in the field of pharmaceutical production and development.

The Gronau site manufactures solid forms, packaged in blisters and bottles, and offers quality services such as analytical & microbiological testing; stability studies according to ICH guidelines, development and testing of packaging components, PQR as well as galenical & analytical development; manufacturing / packaging / distribution of clinical studies, handling of narcotics (approval).

 

More information here: Aenova Group

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Certifications

• EMA (EU GMP)
• FDA (cGMP)
• ANVISA (Brazil B-GMP)
• Roszdravnadzor (Russia GMP)
• PMDA/MHLW (Japan GMP)
• UAE Ministry of Health & Prevention

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Activity

• Oral solids / OSD, Tablets, Hard capsules, Granules / Pellets, Powders, FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
• 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), PMDA (Japan), EDE (UAE), 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, Formulation / Galenic design, ICH Stability studies, Tech transfer, Scale-up, Analytical methods development, Analytical methods validation, Primary packaging, Secondary packaging, Labeling, Serialization

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