Quality Assurance / Management System

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 th...

Bushu managed Packaging for Regeneration Medicine

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...

If there is a consumer complaint or an issue in the manufacturing process, a timely response is required.
Both non-destructive and destructive analysis is available. Knowledge and experience of manufacturing for foreign materials based on the results of analysis.

Methodology
1. Micr...

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 formulat...

Bushu Pharma, as a CMO, has a social and patient responsibility to ensure the smooth, continuous production of pharmaceuticals - even in the face of a national disaster.
Bushu Pharma offers a very strong BCP system for its customers – allowing bulk and final product inventory to be reduced. The prepar...

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.
...

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 par...

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

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 ...

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 b...

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...

- “Gateway to Asia” Contract Manufacturing Organization (CMO) Agreement to Double Volume of Drugs Produced for Amgen by Bushu Pharma -

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.

We are pleased to announce that the opening ceremony of Kazo Packaging Center was held on October 20, 2021. 

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.

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.

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...

- 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 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.

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

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.

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.

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.

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.

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.

”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.

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