Hungary Europe
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: INDUSTRIAL BUSINESS PARK IN CENTRAL EUROPE, APPROX. 100 KM FROM A MAJOR CAPITAL CITY, WITH EASY ACCESS TO A MAIN MOTORWAY
- 2012: Comprehensive reconstruction, expansion, and modernization, including the installation of advanced technologies
- Total plant area: approximately 1,100 square metres
- EU GMP certification for the manufacturing of veterinary medicinal products
Quality control laboratory with EU GMP certification – ensuring efficient product release and full compliance with EU regulatory requirements.
Extensive experience in product registration, with established relationships with multiple EU regulatory authorities and a broad portfolio of registered products.
MANUFACTURING ACTIVITIES
- Powder production
- Premix and powder manufacturing
- Typical batch size: 250 kg
- Packaging formats: 10 kg, 25 kg, 30 kg
- Manufacturing of oral and external solutions and suspensions
- Solution preparation (typical batch size: 500 litres)
- Dosage forms: solutions and suspensions
- Filling capacity: up to 5,000 ml
- Sealing: inductive sealing of containers
- Daily output varies depending on product characteristics
- Tableting
- Capacity: 30,000–70,000 tablets/hour
- Tablet weight range: 400–1,200 mg
- Blister packaging
- Compatible with PVC and aluminium materials
- Carton size up to 110 mm x 140 mm
- Primary and secondary packaging
- In-process and quality control laboratory (IPC/QC)
- Bioanalytical laboratory
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
