Quality Assurance / Management System
We employ the world-renowned quality system that Japanese manufacturing is known for, calling on more than 400 experienced staff in our quality assurance and quality control departments to ensure the best products for our customers.
- GMP certification from 43 countries
- Established comprehensive quality assurance system employed to maintain high quality and reliability levels
- Ability to accurately grasp our customers' needs through close communication provided in English or Japanese
- Continuous acquisition of new technology in order to further increase production quality levels
- Established procedures for quality system management that meet international standards
- Voluntary data management system (LIMS)Responsive actions ensuring data integrity
- Continuous quality education and training
More products from Bushu Pharmaceuticals Ltd.
Supporting your Global Expansion
Using the production capacity of our two factories in Japan, Bushu Pharma supports both Japanese and global pharmaceutical companies looking to launch their products in new markets.
We closely communicate with you from project kick-off to actual product launch, we will ensure we are the best partne...
Export to Asian Pacific Markets
Bushu has followed PIC/S and GMP/GDP.
- QC test according to USP, EP, JP and Chinese pharmacopeia
- Serialization packaging for South Korea and others
- Control process room temperature within each country's regulations
- Storage for stability test for climate zone IVb
New product launch support for Japanese and Asian markets
Bushu has supported many global clients to launch new products for Japanese and global markets.
Bushu has close communication with client from kick-off to launch for the following items:
- Project management
- Technical transfer - Artwork
- Packaging specifications qq...
High potency product
We manufacture formulation of high potency products ranging from clinical samples to pharmaceuticals Our manufacturing environment is based on hazard assessment, exposure assessment, and implementing strict residue management.
In addition, we monitor the environment and verify the containment by m...
Cold Chain Management
Many pharmaceutical and biologic drugs today are extremely sensitive to the conditions in which they are packaged, shipped and stored, with temperature deviations affecting the quality of product delivered. Bushu Pharma is skilled in the management of these factors and will ensure your products are handled wi...More info
Contract Manufacturing of Clinical Samples
We have a wealth of experiences in contract manufacturing to be able to produce clinical samples as our clients’ specifications. In addition to manufacturing placebos, we can provide packaging for your double-blind testing. So We have accommodated increasing requirements of clinical samples each year. We cove...More info
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