Aenova Group - Location Feldkirchen, Germany

Aenova Group - Location Feldkirchen, Germany

Competence Center Semisolids and Liquids.

About the plant

The site has special expertise in the production and packaging of semisolid dosage forms.

As a Competence Center for Semisolids and Liquids is specialized for the manufacturing and packaging of creams, ointments and gels in different types of tubes.

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Compliance

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• Roszdravnadzor (Russia GMP)
• 13485 (Medical devices)

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Activity

• Oral liquids and semisolids, Tubes, Bulk, Oral gels, Oral foams, FDF / DRUG PRODUCTS, COSMETICS, Cream / paste, Foam manufacturing

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Features

• Uses: Commercial (Phase IV), 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), 4 / HPAPI (PDE = 10 - 100 µg/day)
• Controlled substance: N/A
• BSL: N/A
• Therapeutic areas: (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system
• Markets: FDA (USA), EMA (EU), Russian Health Authorities

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, R&D, Formulation / Galenic design, Stability studies design, Stability studies execution, Tech transfer, Primary packaging, Secondary packaging, Labeling, Serialization

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