FDF / DRUG PRODUCTS NUTRACEUTICALS in Europe
The plant is EU GMP certified and produces veterinary medicinal products for 18 EU Member States and 7 other European coutries outside the EU.
About the plant
MAIN CHARACTERISTICS OF THE PLANT
LOCATION: BÁBOLNA BUSINESS PARK, 100 KM FROM BUDAPEST IN WESTERN DIRECTION, 5 KM FROM THE M1 MOTORWAY
- 2012: Comprehensive reconstruction, expansion, modernization, with installation of cutting edge technologies
- The entire ground-space of the plant is 1,100 square metres
- EU GMP certification for the manufacturing of veterinary medicinal products
Quality control laboratory with EU GMP certification – a guarantee for fast product release and documents conforming to the EU requirements.
We are pleased to offer our wide-ranging registration experience. We have active relations with the competent authorities of 18 EU member states and numerous products with EU registrations.
MANUFACTURING ACTIVITIES
· Powder production
· Premix and powder production
· The general batch size of premixes and powders are 250 kg
· Bag sizes: 10 kg, 25 kg, 30 kg
· Manufacturing of oral and external solutions and suspensions
· Solution preparation (general batch size 500 litres)
· Product types- solutions- suspension
· Filling - maximum filling volume is 5000 ml
· Closing flacons with inductive seals
· The daily capacity depends on the characteristics of the product
· Tableting
· 30.000-70.000 tablets/hour
· 400-1200 milligram tablet weight
· Blistering
· Suitable for PVC and aluminium packaging materials
· Card size of even 110 mm x 140 mm
· Primary and secondary packaging
· IPC/QC Laboratory
· Bioanalitical Laboratory
CONTACT: Manufacturing.babolna@alpha-vet.hu
Compliance
- ISO
- EMA (EU GMP)
- 9001
Activity
- Oral liquids and semisolids, Oral solids / OSD, Oral solutions, Oral suspensions, Tablets, Hard capsules, Powders, FDF / DRUG PRODUCTS, NUTRACEUTICALS, Blister packs, Bottles: Plastic, Cans / Tins manufacturing
Features
- Uses: Commercial (Phase IV), Veterinary
- Toxicity (OEB classification): N/A
- Controlled substance: N/A
- BSL: N/A
- Therapeutic areas: N/A
- Markets: EMA (EU)
Batch Size / Reactor
- Medium, Large
Services
- Manufacturing services, Analytical / QC services, Packaging, Primary packaging, Secondary packaging, Labeling
