Choose the optimal dosage form for your drug product
Good Manufacturing Practice (GMP) manufacturing of drug products for small molecules is a highly regulated and meticulous process designed to ensure the safety, efficacy, and quality of pharmaceutical products. GMP guidelines, established by regulatory agencies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency), provide a framework for manufacturing processes, facilities, and quality control systems.
Our expertise
Within our GMP-compliant manufacturing facilities, we offer clinical trial and commercial manufacturing of non-sterile & sterile dosage forms, adhering to the requirements of Good Manufacturing Practices.
Our manufacturing capabilities cover various drug product types, including solutions, suspensions, emulsions, semi-solids, capsules, and tablets.
Beyond the manufacturing process, we perform the release and stability evaluation of the drug products produced in-house. Our testing methodologies include Accelerated Stability Studies, ICH stability testing, and the ASAP (Accelerated Stability Assessment Program). These evaluations ensure that the manufactured drug products meet the required quality standards and remain stable throughout their shelf life.
Non sterile manufacturing capabilities
Our state-of-the-art facilities and expert teams offer comprehensive capabilities for the non-sterile GMP manufacturing of drug products (solid, semi-solid and liquid). Our capabilities encompass the entire manufacturing process, from raw material sourcing to final product testing and packaging. Conventional technologies (e.g. different types of granulation, capsule filling, tableting) as well as innovative technologies (e.g. multiparticulates like minitablets or beads, bilayer tablets, nanomilling) are available.
Our capabilities
| Type of solution | Batch size |
|---|---|
| High shear granulation | up to 35kg |
| Fluid bed granulation | up to 20kg |
| Pan coating | up to 10kg |
| Spray drying | multikilo |
| Trimix | up to 50L |
| Tableting | up to 40 000 units per hour |
| Roller compaction | Up to 100kg per hour |
| Capsules filling | Up to 25 000 units per hour |
| Sachets | 3000 units per hour |
| Blistering | up to 7500 units per hour |
Sterile manufacturing expertise
Our advanced production lines are designed for both liquid and lyophilized forms, catering to various fill volumes and minimizing dead volume. We accommodate a broad spectrum of compounds, primary packaging systems, batch sizes and fill volumes.
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