Our Services

We seek to be the best partner for pharmaceutical manufacturers by assisting the research, development, and production of pharmaceutical intermediates, APIs, and other raw materials in accordance with each company’s development stage of “creating medicine.” Our system flexibly responds to any issues that arise to ensure quick and reliable delivery of medicines to patients.


Contract Research and Development Business

Synthetic route development

We use our expertise in organic synthesis and process chemistry to quickly build synthetic routes

Speed is essential in the early stages of product development. When we receive the structure of the target compound, we are capable of rapidly developing the synthetic route and adapting it for drug discovery or industrial production. The specialist in API synthesis must promptly respond to client needs related to the manufacturing method, quality, and cost, while developing a synthetic route capable of being scaled up into a commercial process.

Synthetic route development

Manufacturing method development and scale-up

We quantify the scale-up factor to formulate a highly robust manufacturing method.

In addition to our extensive experience scaling up operations, we use our organic synthesis and chemical engineering technologies to build a robust and cost-effective API manufacturing processes meeting evidentiary standards for drug application. We ensure design quality by formulating in-process and inter-process testing methods and conducting impurity risk assessments of the final products.

Manufacturing method development and scale-up

Process Safety Assessment

Process safety is enhanced by preliminary evaluations of runaway reactions and pyrolysis.

API manufacturing often includes processes with autoreactive compounds and substances with high calorific reactions. Manufacturers must know the thermal stability of reagents and intermediates and the potential dangers from synthetic reactions before production begins. Our process designs incorporate tests with SC-DSC and reaction calorimeters to evaluate the thermal decomposition behavior and the risk of secondary reaction runaway.

Process Safety Assessment

Inquiry from client

  • Conclusion of confidentiality agreement
  • Presentation of client's target compound
    (if possible, presentation of simple virtual synthesis route)

Conclusion of basic agreement

  • Investigation of compound synthesis methods and conclusion of basic agreement on investigation of sample synthesis, standards testing methods, etc.

Presentation of estimate covering investigation of synthesis methods to sample synthesis

  • Presentation of estimate for laboratory testing expenses required for investigation of synthesis methods and sample synthesis
  • Presentation of overall plan covering investigation of synthesis method to small- and medium-volume manufacturing
  • Determination of researcher team size based on number of processes, difficulty, delivery schedule, etc.

Investigation of synthesis methods

  • Thorough reporting of status of investigation of synthesis methods via discussions, e-mail, phone conferences, teleconferences, etc.
  • Establishment of synthesis method and approval by client
  • Synthesis of small-volume samples to confirm the soundness of the manufacturing method

Presentation of estimate for small-and medium-volume manufacturing

  • Presentation of estimate for small- and medium-volume production using the manufacturing method
  • Compliance with GMP manufacturing is also possible

Conclusion of manufacturing contracting agreement

  • Conclusion of manufacturing contract for small- and medium-volume manufacturing

Small-and medium-volume manufacturing

  • Manufacture under laboratory scale (to 10L), pilot manufacture scale (30L to 150L), and small and medium manufacturing scale (300L to 2000L)

Inquiry from client

  • Conclusion of confidentiality agreement
  • Presentation of client's target compound and manufacturing processes

Presentation of estimate

  • Presentation of cost competitive estimate for manufacturing, testing, etc., in accordance with the indicated manufacturing processes
  • Selection of contractor by the client

Conclusion of contracting agreement

  • Conclusion of contracting basic agreement or manufacturing contract

Pre-manufacturing technical transfer

  • Technical transfer discussions concerning manufacturing methods and testing methods
  • Pre-manufacturing audit and equipment observation by client

Trace and usage testing

  • Performance of trace testing in accordance with the indicated manufacturing process
  • Performance of pre-manufacturing usage testing using the supplied raw materials

Modification of GMP documentation

  • Creation of product standard code, standard manufacturing process, manufacture order, standards testing method, and other GMP documentation.
  • Approval of GMP documentation by the client

Medium- to large-volume manufacturing

  • Medium-volume manufacturing of products from initial to mid-term development, primarily at Hirakata plant (300L to 2000L, several kg to 100kg)
  • Large-volume manufacturing of late-term development products with large quantity, primarily at Toyama Plant (2000L to 10000L, 100 kg to several hundred kg)

Contract manufacturing Business

We follow good manufacturing practices to enable stable production for various scales and reaction conditions. Katayama Seiyakusyo is a comprehensive provider of high-quality products for all stages from initial development to market launch.


Establishment of manufacturing processes

  • Optimization of manufacturing process with cooperation of client
  • Establishment of scope of operation, scope of management, and permissible scope of evidence for each process parameter, through laboratory testing (determination of design space)
  • Creation of development report

Conclusion of supply and quality agreements

  • Conclusion of supply agreement
  • Conclusion of quality agreement

Conclusion of supply and quality agreements

  • Implementation of DQ, IQ, and OQ for equipment and machinery
  • Implementation of test manufacturing, PQ manufacturing, and process validation manufacturing
  • Implementation of cleaning validation and continuous process verification

Handling of administrative review and application

  • Handling of domestic and overseas administrative review
  • Cooperation with client's (marketing authorization holders') applications

Mass production

  • Mass production at Toyama plant following approval (2000L to 10000L, several hundred kg to tens of tons)
  • Consultations regarding expenses for No, 1, 3, and 5 as appropriate

DQ:Design Qualification
IQ:Installation Qualification
OQ:Operational Qualification
PQ:Performance Qualification