Adragos Pharma

Adragos Pharma

Global CDMO partner, providing Development and Manufacturing services for drug products.

About the plant

As a global CDMO headquartered in Munich, Germany, we are committed to fulfilling the pharmaceutical needs of clients throughout Europe, Japan and North America.

We provide comprehensive Development and Manufacturing services for drug products, from small molecules to large molecules. We offer end-to-end services for your small molecule finished dosage forms (FDFs), including sterile and non-sterile liquids, solids, and semi-solids products, and we are also specialized in biologicals, orphan drugs, clinical trials, fill-and-finish, and lyophilization.

Visit our website: https://adragos-pharma.com/ 

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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

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Activity

• Abs (Antibodies), Peptide, protein, hormone & enzyme, Vaccines, 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, Powders, Lyophilizates, Terminal sterilization, Fill&Finish, BFS (Blow Fill Seal) ampoules, Bottles, Tubes, Semisolid forms, Liquid forms, Suppositories and vaginal ovules, tablets, capsules, rings, Terminal sterilization, Fill&Finish, BFS (Blow Fill Seal) ampolues, Small volume vials, Glass ampoules, PFS (Prefilled Syringes), Flexible bags / Infusion systems, FDF / DRUG PRODUCTS, BIOLOGICS, SERVICES manufacturing

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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:
• 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)

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Batch Size / Reactor

• Small, Medium, Large

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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, Fill&Finish, Sterile product manufacturing, 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

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