Adragos Pharma | Athens
Specializes in the development of Value Added Medicines and has been recently upgraded with HPAPI capabilities.
About the plant
Adragos Athens is a Contract Development site that focuses on providing quality services for both generic and speciality pharmaceutical companies. We specialise in Generics, Value Added Medicines (VAMs) and New Chemical Entities (NCE) developments. We have a highly experienced team of more than 60 scientists that have worked on numerous innovative products. Our facility can handle HPAPI.
We offer tailor-made services that cover a wide range of industry needs from custom developments to advanced formulation services. Adragos Athens can help customers with a diverse range of development requirements.
Certifications
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- World Health Organization (GMP / HACCP)
- NMPA (China GMP)
- ANVISA (Brazil B-GMP)
- MFDS/KFDA (Republic of Korea GMP)
- PMDA/MHLW (Japan GMP)
- MHRA (UK GMP)
- UAE Ministry of Health & Prevention
- NSF
Activity
- Oral liquids and semisolids, Oral solids / OSD, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Injectables, Bottles, Ampoules, Oral solutions, Oral suspensions, Oral emulsions, Syrups, Oral gels, Tablets, Hard capsules, Granules / Pellets, Powders, Lyophilizates, Terminal sterilization, Fill&Finish, BFS (Blow Fill Seal) ampoules, Bottles, Tubes, Semisolid forms, Terminal sterilization, Fill&Finish, Small volume vials, Glass ampoules, PFS (Prefilled Syringes), Flexible bags / Infusion systems, FDF / DRUG PRODUCTS, SERVICES manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
- 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), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
- DEA: Schedule II (high potential for abuse / medical use)
- BSL: N/A
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), SFDA (Saudi Arabia)
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, ANDA (Abbreviated New Drug Application) submission support, CTD/eCTD compilation and submission
Address
59, oannoi Metaxa str, Koropi 194 41
Year
1996
Germany
Plant Documents
Other plants of this company
Adragos Pharma | JuraWe specialize in aseptic manufacturing of lyophilized or liquid sterile (bio)pharmaceutical drug products through fill and finish.
Adragos Pharma | LeipzigSemi-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 | HaldenWe specialize in the manufacturing of IV bags, plastic ampoules and vials using Blow-Fill-Seal (BFS) technology and other dosage forms.
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