Cold Chain Management

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 cover contracts from shallow, small-scale and early phases to large-scale and final phases. 

Bushu Pharma has a well trained Clinical Trials Team in our packaging department, providing the following services:
They are well trained for any Clinical Trials package and are able to provide the service with just a short lead time.

- Package engineering
- Package material management- QC testing
- GMP release- Product delivery

Bushu Pharma strives to be a company highly valued for its contributions to human health through the manufacturing of the finest quality pharmaceuticals.
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

1. Business model
- For global clients by Japanese high standard 
- Total management for Contracted Development Manufacturing Organization (CDMO)
- To be a good business partner like a group company of the customer in their Supply Chain Loop Bushu has covered from development to formulation, packaging, QC test and product distribution with following licenses and presentations.
- Licenses: Pharmaceutical manufacturing, Biological product manufacturing, Medical device, Animal health drug and distributors
- Presentations: Vial, Syringe, Auto injector, Cartridge, PFS/device kit, Tablet, Capsule, Granules and Dry syrup

 2. Strategic drivers for success
- Worldwide market fields and Asia Pacific Hub packaging plant
- Import bulk product and package for Japanese and Asia Pacific markets
- Export bulk product and final product globally

Bushu has committed the Production Capacity, Flexibility and Growth for global clients as an Asia Pacific Hub.

- Production capacity: 3 billion tablets/year and others
- Back-up site: Provide Kawagoe and Misato factories
- Stable product supply: Business Continuity Plan (BCP)
- Speed: Minimize technical transfer period before launch and production lead time after launch
- Capital Investment: Risk sharing among clients and Bushu
- KAIZEN: Continuous improvements and feed back to clients
- Quality system: Follow c-GMP, PIC/S GMP, J-GMP, etc
- Quality Assurance:Inspect product by high skilled visual inspectors
- Environment, Health and Safety (EHS): Closed system based on the Bulk Substance risk assessment
- Cost performance: High quality with global competitive cost
- Customer satisfaction: Quick response for customer complaint to analyze foreign particles by X-ray Microscope or FT-I

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

At our Medical Device Center, we manage the inspection and packaging of medical device combination product, drug delivery, and medical grade materials + devices.

Bushu Pharma manages the operations:

- Medical device assemble for syringe
- Packaging for medical device - Packaging for combination product (drug & device combination) at the new dedicated building.- Inspection for products

We manage animal healthcare products and have manufacturing licenses for both animal healthcare products, animal healthcare biological products, and medical devices.

Our experts are able to respond to the needs associated with veterinary medicine. Industrial transfers can be made smoothly through the use of equipment which is similar to their existing manufacturing equipment. Our GMP laboratory can also carry out stability studies.

Bushu managed Packaging for Regeneration Medicine

Bushu Pharma handles the artwork change with the artwork version management.

- Draft of artwork design
- Finalized artwork
- Packaging material procurement
- Incoming tests

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
- Vendor management for packaging materials
- Pre-approval Inspection (PAI)
- Flexible plan for the process operation
- Storage finished products at Bushu warehouse and deliver directly to wholesalers as a distributor, if requested.

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 measuring the exposure to workers.  In principle, OEL (Occupational Exposure Limits) is 0.1～1(μg/㎡).  OEB (Occupational Exposure Band) are OEB4 and/or 5 level and hormone product   production scale is mainly from 5 through 15kg. Dosage form is Granules, plain tablets, coated tablets.

Bushu has operated for following high potency products.

- Formulation for OEB 5 level product
- Formulation for OEB 4 level product
- Formulation for Hormone product

Bushu Pharma proactively manages projects with the right team of specialists in technical transfer, packaging, formulation, qualification and validation, production, regulatory affairs, quality management, and supply chain management for new product from kick-off to validation batches.
To maintain continuity and effective communication with our clients, Bushu Pharma's project management team make every effort to mirror the client’s team. To create the most appropriate project plan, we create opportunities to exchange questions and answers based on each member’s own functional expertise with customers, the pharmaceutical companies. Our project members identify the points through standardized questionnaires, used throughout all phases of the project.

New Bushu Pharma President Tadao Takano has a proven track-record taking biopharma companies to the Japanese market and will drive the company’s strategy to enhance key services, partnerships and policies.

- Agreement Reached with Suzuken Group Subsidiary Chuo Unyu to Establish Kazo Packaging Center, Further Enabling Premier Japanese CDMO’s Prompt and Reliable Pharmaceutical Contract Manufacturing Services -

Bushu Pharma's "Gateway to Asia" service supports customers in their desire to launch new products in Japan and across the larger Asian region. Our Gateway to Asia service lets international pharmaceutical companies import bulk products into Japan for quality inspection, labeling, packaging and distribution throughout Japan and other Asian countries. The service lets you focus on your core businesses and avoid having to deal with the difficult process of managing lead-time, temperature, security, inventory, packaging and urgent order handling across multiple markets.
Collectively, our services offers reduction of lead time from purchase order to shipping, financial and physical flow, oversight of inventory management for Asian markets, forecast review, and planning and operations based in GMP expertise.

The new business alliance will support new product launches for specialty pharmaceutical manufacturers looking to enter the Japanese market

Bushu Pharma announced a major capital program, which will see the company invest USD $100m to expand its footprint, capacity and services over the next five years. The company is also set to launch its new 3,900 square meter (42,000 sq. ft.) cold chain warehouse and packagin building facility, which is used for storage of temperature-controlled sterile drugs and biologics. The new facility is an important component in the company’s ‘Gateway to Asia’ hub strategy which enables international pharmaceutical companies to import bulk product into Japan for quality inspection, labeling, packaging and then distribution throughout Japan and other Asian countries. The company is also placing a high priority on the further strengthening of its multi-international GMP certifications across the North American, European, and Asian markets.

Commitment to Value Creation – identifying the client’s needs. As a healthcare CDMO, we produce and deliver high quality healthcare products. By ensuring optimized QCD (Quality, Cost, Delivery) through our advanced technology and production capacity, we create strong partnerships with pharmaceutical manufacturers. We strive to help them achieve the customers' business goals and build lasting relationships through which we support the construction of global supply chains and promote advancement in new fields of business, such as Drug & Device combination products.
Manufacturing Capability – reliable, on time, in-spec, highest yield, excellent technical transfer… all at a reasonable cost. Bushu Pharma supplies quality products at competitive prices, guided by our world-class commitment to GMP.
We have obtained GMP certification in Japan, the US, Europe, and many other countries and have grown into a manufacturing company able to handle a wide range of hea...

When western companies have established themselves in their regions, the Asian markets hold opportunities for their business expansion. In there, Japan is a one of prime targets for these expanding companies. However, launching into an unfamiliar market poses tricky obstacles. Bushu Pharma has a vast experience of 22 years in launching multinational clients into the Japanese market as one of the leading CMOs in Japan.

Bushu Pharma’s Gateway to Asia solution increases SCM efficiency for pharma manufacturers.

With the FDA approving the second highest number of drugs in the past 20 years (53 drugs in 2020; 59 drugs in 2018), there is high demand for manufacturing and supply chain support in order to allow these new drugs to reach markets around the world.

In response to these requirements and drawing on the company’s GMP expertise developed over the past 20+ years, Bushu Pharma’s “Gateway to Asia” (GTA) service lets international pharmaceutical companies import bulk products into Japan for quality inspection, labeling, packaging and distribution throughout Japan and to other Asian countries. The service is geared towards both manufacturers and distributors – allowing companies to focus on core business activities rather than spending much time and effort on the difficult process of managing lead-time, temperature control, security, inventory, packaging, and urgent order handling across multiple markets.

Given the world-renowned quality level of Japanese manufacturing and the country’s expertise in domestic and regional distribution that was developed in line with the country’s focus on just-in-time supply chain management, the GTA service is geared to help respond to the ever-increasing number of new drugs being developed around the world that are targeting Japan and other Asian markets for new launches in 2021 and beyond.

Bushu Pharmaceuticals Ltd., one of Japan's largest contract manufacturers of pharmaceutical products, announced a major capital program costing $100 million to expand its footprint, capacity and portfolio of services. The program extends over the next five years in order to accommodate client needs.

Bushu Pharma helps improve the packaging and storing process which must be validated to ensure that there is no negative impact to the safety, efficacy or quality of the drug.
Through our Cold Chain logistics service, we enable the market expansion for temperature-controlled bio-pharmaceuticals (maintained at 2℃ to 8℃) to the Japan market, as well as to countries across Asia and beyond. We store and transport pharmaceuticals in line with each product's specific storage and security requirements, maintaining cold chain integrity throughout each step of the delivery process.

An internationally recognized, multi-dimensional standard which brings the highest level of product quality to our clients worldwide.

”Gateway to Asia” service lets international pharmaceutical companies import bulk products into Japan for inspection, labelling, packaging and distribution throughout Japan and other Asian countries.

We accept contracts for the manufacture of pharmaceutical products and clinical samples of solid dosages and injectables - offering a breadth of expertise in technical transfer.

With more than 22 years + GMP certification in more than 55 countries as a contract manufacturer, we are constantly focused on how to improve our ability to deliver quality products.