Manufacture of medicinal products
Do you have any problems dealing with special/Unique manufacturing process or drug substance.
Our customer support system covers not only the manufacture of medicinal products by routine standard method of manufacture but also the manufacture and packaging of drug substances and solid dosage forms of medicinal products.
Our FDA / EMA approved facility capability includes; cephem and carbapenem antibiotics, which require sophisticated powder containment due to their high degree of sensitizing potential. The manufacture of highly pharmacologically active substances is in our line of services.
We also offer contract services specialized in the manufacture of high-quality products in general based on our comprehensive manufacturing technologies and quality control systems that have been rigidly inspected by regulatory agencies including the US FDA and EMA.
We provide a full range of services from medicinal product development to investigational drug and commercial product manufacturing
Drug substance manufacturing process development and process chemistry technology development
- Evaluation of synthesis process of drug substance and process design and development (evaluation from chemical reactions to synthetic product isolation)
- Process safety and environmental impact assessment
- Improvement of manufacturing method (cost reduction and throughput improvement)
- Synthesis of reference standards, impurities, and samples for evaluation
- Designing of formulations (e.g. oral, injectable, and topical formulations)
- Designing of functional and specific clinical formulations (e.g. orally disintegrating tablets, multilayer tablets, sustained-release formulations, solid dispersion formulations, bitter taste-masked formulation, granular formulations, and dry syrup)
- Improvement of existing available formulations (e.g. improvement in dissolution rate, stability, and consistency in the manufacturing process)
- Designing of packaging and labeling systems (e.g. oral, injectable, and topical formulations)
- Designing and development of functional packaging systems (e.g. barrier and child-resistant packaging)
- Designing and development of environment-conscious and ease-of-use-oriented packaging systems
Investigational drug manufacturing
- GLP-compliant manufacturing of non-clinical samples
- Manufacture of drug substances and investigational drugs for clinical trial
- Manufacturing facilities capable of performing efficient syntheses of molecules in several to several tens of kilograms and productive manufacturing of drug substances and finished products of various dosage formulations (e.g. solid, injectable, and topical formulations)
Support for regulatory submission application
- Data collection for regulatory submission application and application support (new drug application and partial changes to approval matters)
- Evaluation of industrialization process (e.g. scale-up and optimization of commercial manufacturing facility)
- Technology transfer (in-house and outside CMOs)
- Manufacturing of drug substances, API, and finished products (e.g. oral, injectable, and topical formulations) and preparation of packaging and labeling materials
- Manufacturing of not only generic medicines but also commercial production of unique clinical formulations and highly potent compounds developed with Shionogi Pharma on the contract basis
- Handling and management of manufacturing and supply of medicinal products for overseas markets and preparation for factory inspection by foreign regulatory agencies