Stable production under a product development process that complies with GMP standards

There are various regulations on pharmaceutical development and manufacturing both in Japan and elsewhere. Based on our experience, we extensively support our customers and supply highly reliable products under our GMP-compliant quality assurance system.

Advantages of contract manufacturing

・Business continuity (decentralization of production) can be ensured in emergencies.
・Production using our facilities allows customers to avoid substantial investment in manufacturing facilities.
・Our reliable product management capability allows customers to reduce costs for managing the manufacturing process.
・Customers’human resources can be used effectively and efficiently.

Strengths of YUKI GOSEI KOGYO

• ・Development, manufacturing and commercialization in compliance with GMP standards We have been engaged in development of drug intermediates, new drugs and generics over many years. As a partner to our customers, we provide contract manufacturing services that take advantage of our many years of experience as well as provide support for commercialized products.
• ・Export to more than 30 countries and global business expansion There are various standards on pharmaceutical development and manufacturing both in Japan and elsewhere. Our products are manufactured under our GMP-compliant quality assurance system, meet regulatory standards of different countries, and are exported to more than 30 countries around the world.
• ・Abundant experience with overseas applications Even if a product complies with regulatory requirements in Japan, the US and EU, it is sometimes required to provide additional information and data. We identify the information that is required in each country according to a customer’s plan for product development in order to successfully file an application and receive approval.

Flow of contract manufacturing and GMP-compliant process

We develop and manufacture products in a process that meets strict GMP standards in order to achieve customer’s demand.
We provide services not only for development and manufacturing but also for application and commercialization in line with the customer’s development plan.

Flow of contract manufacturing

• Consultation/request from a customer Respond quickly and accurately to a request based on in-depth communication
• Research and development Develop a GMP-compliant development plan and propose a manufacturing method, quality, costs, and due date that are most suitable to the customer
• Trial production Produce a small volume of the product on a trial basis and discuss what should be improved with the customer
• Contract signing and full-scale manufacturing Efficiently produce the product on a large scale at our plant to be supplied as agreed
• Support in filing applications and commercialization File applications regarding the developed and manufactured drug and commercialize it.
  Provide support services in line with the domestic development plan and the overseas plan, respectively.

Major manufacturing technology

Grignard reaction, esterification, alkylation, alkoxylation, acylation, amination, amidation, diazotization, cyanation, condensation reactions, reductions, etc.

* We identify an optimal manufacturing method, obtain approval for pharmaceutical manufacturing, prepare DMF, make registrations, and manufacture products on a commercial scale under a quality control system that complies with GMP and ISO 9000 standards.

Facilities

Our manufacturing facilities are GMP-compliant.