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As a contract development and manufacturing organization (CDMO), we provide a rapid and accurate response to clients’ requests over a wide range of services; from route design to scale up study, pilot manufacturing, and commercial manufacturing by using our unique process that combines organic synthesis technologies and biotechnologies, based on our long-term knowledges and experiences.
Regarding our unique process development business, we provide proposal-oriented business as well as manufacture and market active pharmaceutical ingredients (APIs) and intermediates using our original processes based on unique organic synthesis technologies and biotechnologies.
CDMO Business
Services We Offer
- Route Design
- Scale up Study
- Pilot manufacturing
- Commercial manufacturing
Our Strength
Hybrid Processes combining organic synthesis technologies and biotechnologies, based on our long-term knowledges and experiences
Details
We use optimization tools such as reaction, flow, multivariate analyses and scale up methods based on the know-how for Kilo lab & Pilot production.
As to our APIs and intermediates manufacturing, we proud to satisfy our clients with Speed, Cost, Quality and Safety at our cGMP-compliant multi-purpose plants.
In order to proceed with the project, we provide the best solutions to accurately reflect clients’ requirements with experts integrating from the fields of research, development, manufacture, quality assurance, and intellectual property under the executed confidential disclosure agreements (CDA).
We also support the process development under Full-time equivalent (FTE) contracts to meet the varieties of needs from our clients.
In addition, we provide a variety of services relating to the manufacture of APIs and intermediates, such as stability testing, drug master file (DMF) drafting, and other applications.
Our Unique Process Development Business
API Corporation provides the proposal-oriented business based on our technical knowledges such as cost-competitive manufacturing routes for target compounds and the new manufacturing route to avoid impurities that cannot be controlled by existing methods. We have developed new synthetic methods utilizing fewer reaction steps, and successfully commercialized the products prepared using these approaches.
We manufacture and market APIs and intermediates using our original processes based on unique organic synthesis technologies and biotechnologies. We have a wide variety of products. Please inquire for more details.
Research and Development
In order to establish robust technologies in process development and support our clients’ new medicine developments, we are actively engaged in not only CDMO but also in R&D of our Unique technology development.
Using the biotechnology, one of our core technologies, we have proactively developed processes using specific reactions including reduction, hydrolysis, and oxidation, which result in improving the efficiency of existing manufacturing routes.
For batch process analysis, simulation tools (computational fluid dynamics (CFD), etc.) are used to prevent issues on scale-up manufacturing and reduce the period of process development.
In addition, the study of the Flow Synthesis Technology is undergoing, which is flexible and does not require large equipment.
