Aenova Group - Location Regensburg, Germany

Aenova Group - Location Regensburg, Germany

Competence Center high potent solids (oncology) conventional solids - specialty semisolids & liquids.

About the plant

The Aenova Group site in Regensburg with its special environment is one of the leading HPAPI development, production and packaging facilities for high potent solids:

• - Capsules, tablets and film coated tablets
• - From small to large scale (0,5 to 500kg)
• - Covering complete lifecyle from development to commercial supply for Capsules, Tablets & Film Coated Tablets

The Aenova site in Regensburg is a state-of-the-art facility paired with high flexibility.

Strategic expansions will enable the site´s production capacity to double within the next years. This strategic expansion took place in 2023 to enable the site‘s production capacity for HPAPI to double within the next years and to offer tailor-made/ plant-in-plant solutions for customers.

More information here: Aenova Group

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Certifications

• EMA (EU GMP)
• FDA (cGMP)
• ANVISA (Brazil B-GMP)
• Roszdravnadzor (Russia GMP)
• MFDS/KFDA (Republic of Korea GMP)
• PMDA/MHLW (Japan GMP)
• SFDA (Saudi Food & Drug Authority)
• TITCK (Turkish Health Authorities)

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Activity

• Oral liquids and semisolids, Oral solids / OSD, Bottles, Tubes, Oral solutions, Oral suspensions, Oral emulsions, Oral gels, Tablets, Hard capsules, Granules / Pellets, Powders, FDF / DRUG PRODUCTS, COSMETICS, NUTRACEUTICALS, Spray, Others, Foam 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), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
• DEA: N/A
• BSL:
• Therapeutic areas: N/A
• Markets: FDA (USA), EMA (EU), PMDA (Japan), ANVISA (Brazil), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia), 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, Preformulation studies, R&D, Process development, Tech transfer, Scale-up, Analytical methods development, Primary packaging, Secondary packaging, Labeling, Serialization

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