Aenova Group - Location Cornu, Romania

Aenova Group - Location Cornu, Romania

Competence Center and one-stop shop for Soft gelatin capsules and VegaGels®.

About the plant

This facility specializes in the development, production and packaging of soft dosage forms, including soft capsules and gel-based formulations.

The company has strong expertise in soft capsule technologies and focuses on the development of alternative, plant-based formulations aligned with evolving market needs.

Its gel-based delivery systems are designed to offer improved stability and performance under varying environmental conditions, helping to reduce common formulation challenges during storage. These formats are available in a wide range of sizes, shapes and visual presentations.

Plant-based capsule technologies can support specific dietary and regulatory requirements. Formulations are developed without the use of animal-derived materials and can be adapted to meet additional quality and compliance standards.

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Compliance

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• Health Canada (Canada GMP)
• TGA (Australia GMP)
• Halal Research Council
• 9001
• 13485 (Medical devices)
• 14001

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Activity

• Oral solids / OSD, SoftGel capsules, Gummies, FDF / DRUG PRODUCTS, NUTRACEUTICALS, Suspensions, Oils, Blister packs, Bottles: Plastic, Bottles: Glass manufacturing

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Features

• Uses: Commercial (Phase IV), 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)
• Controlled substance: N/A
• BSL: N/A
• Therapeutic areas: N/A
• Markets: FDA (USA), Health Canada (Canada), TGA (Australia)

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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, Primary packaging, Secondary packaging, Labeling, Serialization

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