Business Overview
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- Company Profile
- Business Overview
Daito meets customer needs by providing high-quality in-house and external products under its manufacturing system that covers the entire range, from active pharmaceutical ingredients (APIs) to formulation products.
APIs
Daito manufactures APIs mainly for generic drugs at its factory and sells them to many customers (pharmaceutical manufacturers).
The Company operates a large volume of equipment that can serve both mass manufacturing and the manufacture of various types of products in small quantities. By doing so, it meets the needs of a wide range of customers, from major and middle-ranking generic drug manufacturers to new-drug manufacturers.
The Company also complies with various quality standards and regulations, including the Japanese Good Manufacturing Practice (GMP) standards, the current GMP (cGMP) regulations on pharmaceutical quality control in the U.S., and the EU GMP Guidelines. Therefore, the Company can manufacture products for American and European markets too.
Furthermore, the Company performs not only a manufacturing function but also a trading function with diverse procurement channels and a high level of ability to collect and provide information.
Generic Drug Development and Manufacture
In Japan, the national government has long implemented various measures to promote more widespread use of generic drugs in order to reduce national medical expenditure. This government policy has provided a favorable tailwind for our business.
Without any MRs or other sales staff, Daito outsources all formulation-product sales duties to other pharmaceutical manufacturers. Therefore, the Company is able to concentrate its management resources on manufacturing. Furthermore, its engagement in both API manufacture and formulation product manufacture enables the Company to ensure information sharing between the two businesses and to use in-house API products to manufacture formulation products, resulting in a reduction in manufacturing costs. Since 2014, the Company has been collaborating with Daito Pharmaceutical (China) Co., Ltd. to optimize both companies’ manufacturing systems.
The Company has also recently focused on the field of high-potent drugs, where there is a high entry barrier. We have been making an active commitment to strengthening our R&D and manufacturing systems for high-potent drugs.
Contract Manufacture of Ethical Drugs
In the wake of the completion of its Fifth Formulation Building in 2001, Daito pioneered the Japanese contract manufacture of new drugs with major pharmaceutical manufacturers as client companies.
After that, the enforcement of the revised Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices in 2005 has enabled the outsourcing of the overall process of pharmaceutical manufacture. This has also been a contributing factor to the expansion of our contract manufacturing business.
Daito meets not only the Japanese Good Manufacturing Practice (GMP) standards but also requirements imposed by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Therefore, the Company can manufacture products for American and European markets too.
We have earned the trust of our customers, including major pharmaceutical manufacturers, by having enhanced our capabilities for quality assurance, on which the highest importance is placed in pharmaceutical manufacturing, and by possessing a wide variety of equipment and technology for pharmaceutical manufacturing.