OUR Facilities
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-solid
Dosage Form
Creams, gels, ointments, healing paste
Formulation
Batch size from 15 to 1,250 liters
Packaging
Aluminum tubes 2 g –150g, Plastic tubes 25 g – 200 g
Technologies
2 production lines, equipped with Marchesini and Norden.
Liquid
Dosage Form
Solutions, drops, suspension, emulsion
Formulation
Batch size up to 4,000 liters
Packaging
Plastic Bottles. Glass Bottles. Size from 25ml to 1000ml
Technologies
3 production lines, featuring Dovema, Groninger and Würschum
Our Services
Technology for Manufacturing
- Becomix mixer of 500
- Multi-homo mixer of 250
- Becomix mixer of 15
- Multi Homo with a capacity of 500 liters
- EKATO-mixing batch tank with capacities up to 4000 liters
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 purview 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
Key Information
Location: Leipzig, Germany
SQM: 13,300 m²
Foundation Year: 1,926
FTE (Employees): 120
Certifications
• Batch certification by a Qualified Person
• 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 Highly skilled and experienced in their field.
Steffen Melzer
Production Management, Leipzig
Cornelia Pauli
Human Resources and Management Assistant, Leipzig
Dr. Daniela Möller
Head of Quality Control, Leipzig
Angela Naumann
HR Manager, Leipzig
Ivan Makhnusha
Head of Quality Assurance, Leipzig
Katja Richter
Transfer, Leipzig
Nadja Wawersinek
Transfer, Leipzig
Marcus Pursche
Transfer, Leipzig
Martin Herbon
Technology and Occupational Safety, Leipzig
Meet our Site Head
Marco Gorgas
Marco is Adragos’ Chief Technical Officer and leads the global manufacturing operations and oversees the development of all sites in our global network. He is currently Head of Site (AI).
He draws on 20+ years of international experience in pharmaceutical operations. Excellent industry knowledge within the Life Sciences particularly in generic pharmaceuticals and CDMO enabled him to substantially shape leading global pharma companies.