Aenova Group - Location Sisseln, Switzerland

Aenova Group - Location Sisseln, Switzerland

Competence Center complex conventional solids.

About the plant

The Aenova Site in Sisseln has special expertise and state of the art infrastructure for manufacturing and packaging of moisture sensitive solid dosage forms.

We are well equipped to efficiently develop and handle the whole solids spectrum ranging from complex niche products up to high volumes.

The Aenova site in Sisseln is an entirely carbon neutral plant with 6 GwH of hydropowered electricity.

More information here: Aenova Group

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Certifications

• ISO
• FDA (cGMP)
• World Health Organization (GMP / HACCP)
• ANVISA (Brazil B-GMP)
• Roszdravnadzor (Russia GMP)
• MFDS/KFDA (Republic of Korea GMP)

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Activity

• Oral solids / OSD, Tablets, Hard capsules, Granules / Pellets, FDF / DRUG PRODUCTS, NUTRACEUTICALS 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), ANVISA (Brazil), MFDS (South Korea), Russian Health Authorities, Turkish 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, Stability studies execution, Tech transfer, Primary packaging, Secondary packaging, Labeling, Serialization

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