API Corporation is the one of top Japanese manufacturers of Active Pharmaceutical Ingredients (APIs)*, and intermediates to provide to pharmaceutical companies.
We offer services in a wide range; focusing mainly in the CDMO (Contract Development and Manufacturing Organization) business of APIs and intermediates, we provide a rapid and accurate response to a variety of clients’ needs in synthetic route design, manufacturing process, pilot manufacturing /investigational medical manufacturing, and commercial manufacturing.
*：Active Pharmaceutical Ingredient or API is the origin of our company name.
Experience and Performance
Our business is not only with the major domestic pharmaceutical companies but also with global companies. In addition to the contract manufacturing of APIs and intermediates, we satisfy a wide range of requests such as route design, process development (scale-up and optimization), etc., which enables us to have good reputations from clients worldwide.
Technology Development Capability based on Abundant Experience
In addition to manufacturing and selling existing products and contract manufacturing products, we also manufacture and market APIs and intermediates developed with our Unique technologies.
We supply not only proposing efficient manufacturing methods based on unique organic synthesis technologies and biotechnologies as our core technology, but also providing the best solutions for each stage in the manufacturing process of APIs.
In order to meet the variety of Clients’ needs, we also support process development under FTE (Full Time Equivalent) contracts.
Comprehensive Strength of Manufacturing
API Corporation has advanced commercial manufacturing technology with vast experiences in scale-up study, manufacturing method improvement, optimization study, and analytical method development, etc. In addition, our CMC service provide for new drug development of pharmaceutical companies the accurate drafting service to DMF and CTD filing in both Japan and overseas.
We have manufacturing facilities that can handle from investigational medical products to commercial manufacturing, and we conduct manufacturing and quality control and quality assurance under the GMP system. We offer global regulatory Compliance with lots of experiences from different regulatory inspections including US-FDA. We also have experienced numerous client audits from around world and have been highly evaluated.
We conduct EHS(the environment, hygiene & safety) management for sustainable (Human & Green Friendly) manufacturing
CMC: Chemistry, Manufacturing and Control DMF: Drug Master File CTD：Common Technical Document GMP: Good Manufacturing Practice