FDF / DRUG PRODUCTS in Europe
Your cGMP-compliant CDMO for end-to-end services in the complex oral solids dosage forms field, based in Binzen Germany
About the plant
Glatt Pharmaceutical Services supports pharmaceutical and biotech companies through every stage of drug product development, from initial formulation design to large-scale commercial manufacturing. With expertise spanning early-stage development, including preclinical and clinical supply production, Glatt ensures seamless scalability while maintaining stringent quality standards. Leveraging advanced technologies like fluidized bed systems, spray granulation, and Wurster coating, Glatt specializes in creating tailored solutions for solubility enhancement, modified release, and other complex drug delivery challenges. Partnering with Glatt means access to end-to-end solutions designed to streamline the path from innovation to market.
Certifications
- EMA (EU GMP)
- FDA (cGMP)
Activity
- Oral solids / OSD, Tablets, Hard capsules, Granules / Pellets, Powders, FDF / DRUG PRODUCTS manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Phase I, Phase II, Phase III, 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), 4 / HPAPI (PDE = 10 - 100 µg/day)
- DEA: N/A
- BSL: 1
- Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (V06) Nutrients
- Markets: FDA (USA), EMA (EU)
Batch Size / Reactor
- Small, Medium, Large
Services
- Development services, Manufacturing services, Analytical / QC services, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Formulation mixing, 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, Analytical methods transfer
