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Adragos Pharma | Leipzig

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.

Germany Europe

Adragos Pharma | Leipzig

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.

Adragos Pharma | Leipzig

About the plant

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.

Semi-solids

Dosage Form: Creams, gels, ointments, healing paste

Batch size: 15l – 1,250l

Aluminum tubes: 2g – 150g; Plastic tubes: 25g – 200g

2 production lines: Marchesini and Norden

Non-Sterile Liquids

Dosage Form: Solutions, drops, suspension, emulsion

Batch size: up to 4,000 liters

Plastic and glass bottles: 20ml – 700ml

3 production lines: Dovema, Groninger and Würschum


Certifications
  • EMA (EU GMP)

Activity
  • Oral liquids and semisolids, Topical, mucosal and transdermal, Semisolid forms, Liquid forms, FDF / DRUG PRODUCTS manufacturing

Features
  • Uses: Commercial (Phase IV), Human, Veterinary
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
  • DEA: Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
  • BSL: N/A
  • Therapeutic areas: N/A
  • Markets: EMA (EU), PMDA (Japan), MHRA (UK), NMPA (China), MFDS (South Korea)

Batch Size / Reactor
  • Small, Medium, Large

Services
  • Regulatory services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution

Address
Elisabeth-Schumacher-Straße 54-56, 04328 Leipzig
Year
1926
Germany
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ADRAGOS PHARMA