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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.

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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

Person

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.

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