Leipzig, Germany
Our manufacturing facility in Leipzig specialises in semi-solid and non-sterile liquid pharmaceuticals. With over 100 years of experience, we have a track record of providing first class service and customer focused manufacturing.
Our Expertise
Semi-solids
Dosage Form
Creams, gels, ointments, healing paste
Formulation
Batch size: 15l – 1,250l
Packaging
Aluminum tubes: 2g –150g; Plastic tubes: 25g – 200g
Technologies
2 production lines: Marchesini and Norden
Non-Sterile Liquids
Dosage Form
Solutions, drops, suspension, emulsion
Formulation
Batch size: up to 4,000 liters
Packaging
Plastic and glass bottles: 20ml – 700ml
Technologies
3 production lines: Dovema, Groninger and Würschum
Our Services
Technology for Manufacturing
- Becomix 1200 liter
- Becomix 250 liter
- Becomix 15 liter
- Multi-Homo 500 liter
- EKATO-Mixer 4000 liter
Stability Testing
- Stability testing for climate area II, IVa and IVb
- Alarm-controlled monitoring of temperature and humidity
- Computer aided time schedule and data control
- Stability tests during clinical development and marketing stage
Quality Assurance
- To adhere with highest standards of quality and safety, we accomplish with regulatory standards, like:
- National/ EU (Landesdirektion Sachsen), In the realm of medicine quality.
- Manufacturing processes conducted under the strict overview of the AMG (Arzneimittelgesetz).
- GMP certification for both human and animal products.
- We measure quality assurance of cosmetics and food supplements, by the Veterinär- und Lebensmittelaufsichtsamt certificate.
Certifications
- QA committee
- Risk-based Qualification
- Supplier evaluation
- PQRs ( Product Quality Reviews )
- Yearly QMR (Quality Management Reviews)
- Self-inspections und auditing
- Risk-based cross-contamination management
- Paper based documentation system
- Validated software: ERP-GUS; Perfact; Seritrack
Quality Control Process
Routine-analytics
- Raw material analysis (active ingredients, auxiliary materials)
- Bulk goods and product analysis
- Batch release testing of solid, liquid & all kind of semisolid formulations
- Stability testing
- Investigation of residual solvents
Microbiology
- Microbiology tests of APIs and products (non-sterile)
- Bacterial counts (TAMC & TYMC)
Method development and validation
- Development of analytical methods and validation (HPLC, GC, GC-headspace, UV-VIS, titration)
- Design of dissolution models
- Development of cleaning validation methods
- Planning and execution of method transfers
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We have prepared a brochure to help you discover our facility in Leipzig.
Key Information
Location: Leipzig, Germany
SQM: 13,300 m²
Foundation Year: 1,926
FTE (Employees): 120
Certifications
• Serialization according to EU FMD (European Union Falsified Medicines Directives)
• Manufacturing permission according to AMG
• EU GMP – Certification (human- & animal products)
Expertise
• Galenical development and transfer management
• Pilot batches
• Worldwide procurement of raw materials
• Production & Packaging
• Analytic and batch release/method transfer
• Stability studies and contract analysis
• Validation/product quality reviews
• Clinical investigational medicinal products
• Creation of product quality reviews
Meet our team in Leipzig
Highly skilled and experienced in their field.
Meet our Site Head
Florian Prell
With a career spanning over two decades in the pharmaceutical and packaging industries, Florian Prell is the new Site Head of Leipzig. A dedicated and results-driven professional, Florian has consistently demonstrated his ability to lead and optimize operations in highly demanding environments.
Florian’s journey through various key positions has equipped him with a comprehensive understanding of plant operations and process optimization. His leadership experience highlights his capability to manage complex, multi-faceted operations while ensuring efficiency and high standards in production.
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