Germany Europe
FDF / DRUG PRODUCTS NUTRACEUTICALS in Europe
Competence Center conventional solids high volume plant.
About the plant
The Aenova Group site in Tittmoning is one of the largest production facilities for oral solids in Europe:
- - High volume solid dosage
- - European quality standards and customer service coupled with efficient and competitive production solutions
- - State-of-the-art facilities paired with highest scalability
- - Know-how in controlled release products and food supplements
Continuous expansions will enable the site´s production capacity to be increased to over 10 billion tablets per year in the future.
More information here: Aenova Group
Compliance
- EMA (EU GMP)
- FDA (cGMP)
- Health Canada (Canada GMP)
- TGA (Australia GMP)
- ANVISA (Brazil B-GMP)
- Roszdravnadzor (Russia GMP)
Activity
- Oral solids / OSD, Tablets, Hard capsules, FDF / DRUG PRODUCTS, NUTRACEUTICALS, Blister packs, Bottles: Plastic, Bottles: Glass manufacturing
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)
- Controlled substance: N/A
- BSL: N/A
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU), Health Canada (Canada), TGA (Australia), ANVISA (Brazil), Russian Health Authorities
Batch Size / Reactor
- Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Primary packaging, Secondary packaging, Labeling, Serialization
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