Businesses of the Daito Group

The Daito Group consists of Daito Pharmaceutical Co., Ltd. and its consolidated subsidiaries: Daito Pharmaceuticals America, Inc., and Daito Pharmaceutical (China) Co., Ltd. Major businesses of the Group are the manufacture, purchase, and sale of APIs and formulation products (ethical drugs and non-prescription drugs), the contract manufacture of APIs and formulation products, and the sale of health foods and other products.

Daito’s major selling items:

  • (1) APIs: Active pharmaceutical ingredients (APIs) are raw materials from which pharmaceutical products*1 are made. The Daito Group manufactures and purchases APIs to sell them, and it also contracts to manufacture APIs.
  • (2) Formulation products: The Group manufactures, purchases, and sells the formulation products of ethical drugs*2 and non-prescription drugs,*3 and it also contracts to manufacture these products.
  • (3) Health foods and other products: Health foods and pharmaceutical-related products, including quasi drugs
  • *1 Pharmaceutical products (drugs) utilize chemical substances’ properties that act on living organisms as a tool for curing human and animal ailments. APIs refer to the chemical substances themselves that have such properties. Many APIs bring about a high pharmacological effect in a small amount, but it is almost impossible to take only APIs at the exact small amounts. So, APIs are processed into a form that makes them work the most effectively: lactose, starch, or other inactive ingredients are added for easy melting or absorption and into an easy-to-use size and volume. These processed APIs are called “formulation products” (such as tablets and granules). Formulation products with necessary packaging and labeling are pharmaceutical products (drugs).
    A typical process of manufacturing pharmaceutical products is as outlined below.
    Daito’s major selling items
  • *2 Ethical drugs refer to drugs prescribed based on prescriptions issued by hospitals and clinics. Ethical drugs are roughly divided into new drugs (original products) and generic drugs (copy products). Original products entail considerable expenses and over 10 years of time to be applied for, approved, and released. For an application, you need basic data on the materials identified for use, pharmacological activity (effect) confirmed, and non-toxicity confirmed with certain animals; data on efficacy and safety confirmed with humans; and data on usefulness. Copy (generic) drugs, in contrast, require low R&D costs and are thus priced lower than the original although they use the same active ingredients as the original and have an equivalent level of efficacy and safety. After the patent for an original drug expires, other pharmaceutical companies may commercialize copy drugs with approval and permission.
  • *3 Non-prescription drugs, also called “self-medication drugs” and “OTC (over-the-counter) drugs,” refer to the drugs that are sold at pharmacies and drug stores and may be bought without a prescription from a medical practitioner.

Features of the Group’s businesses

  • (1) The Group’s standing in the pharmaceutical industry

    Utilizing its rich experience and technical skills it has cultivated since its founding, the Group manufactures and sells not only APIs, or raw materials for pharmaceutical products, but also formulation products. Under a system that enables consistent manufacture of products ranging from APIs to formulation products, the Group deals with a wide variety of domestic and overseas pharmaceutical manufacturers. The Group is also actively engaged in the manufacture and sale of its self-developed products and the products jointly developed with other pharmaceutical manufacturers, as well as contract manufacture for major domestic manufacturers. Its business operation meets a wide variety of needs in the pharmaceutical industry, from original to generic drugs.

  • (2) APIs

    We manufacture and sell in-house and jointly developed products, as well as handle products from other companies.
    In the development of pharmaceuticals (new drugs), the manufacturing process of the drug substance, which is the raw material of the drug, is closely related to the patent of the drug. Regarding production, while it is common for major new drug manufacturers and group companies to produce, generic drugs have expired patents, and as a generic manufacturer (manufacturer and distributor of generic drugs), Due to the need to efficiently stock a wide range of generic drugs, the Group believes that it is common to purchase APIs from other companies rather than manufacturing them in-house.
    Based on this policy of the pharmaceutical industry regarding active pharmaceutical ingredients, the Group mainly supplies active pharmaceutical ingredients developed in-house, mainly to generic manufacturers.
    Furthermore, in recent years in Japan, national medical expenses have long been on the rise due to the progressive aging of society, and the government has promoted the use of generic drugs to control medical expenses as a priority measure. The Basic Policy on Economic and Fiscal Management and Reform 2017, which was approved by the Cabinet in June 2017, clearly states that “by September 2020, the use of generic drugs will be increased to 80%, and further measures will be considered to promote their use in order to achieve this goal as soon as possible,” and the government has implemented this policy to promote the use of generic drugs. The share of generic drugs by volume reached 80.7% in the April 2022 to March 2023 period (according to a survey by the Japan Generic Medicines Association), showing the increasing prevalence of generic drug products. In light of these market trends toward generic drugs, our group has in place production facilities that can handle everything from mass production to low-volume, high-mix production, thereby responding to a wide range of needs in Japan, from large manufacturers to small and medium-sized generic manufacturers.

  • (3) Formulation products

    While actively contracting to manufacture major domestic manufacturers’ original drugs, the Group also develops and manufactures generic drugs to meet the needs of the generic-drug market.
    In addition, the enforcement of the revised Pharmaceutical Affairs Act in 2005 has enabled new-drug manufacturers without their own production facilities to be approved for new-drug applications. Taking advantage of this change, new-drug manufacturers, which invest considerable R&D expense in new-drug development, seem to streamline their business operations by concentrating their financial and human resources on R&D and sale, and there is a growing need for external mid-sized manufacturers that undertake the overall manufacturing process.
    The Group meets not only GMP (Good Manufacturing Practice, or standards for the manufacturing administration and quality management of pharmaceutical products) in Japan but also the criteria required by the FDA (US Food and Drug Administration) and EMA (European Medicines Agency). The Group has gained the trust of major new-drug manufacturers by enhancing its quality management ability, to which utmost importance is given in the manufacture of pharmaceutical products. The Group also owns production facilities that support various dosage forms, which enables it to contract to manufacture drugs for major new-drug manufacturers.

  • (4) R&D, manufacture, and sales systems

    The Group has established a system for manufacturing a wide range of APIs and formulation products. This system enables the Group to gather a wide variety of information, from APIs to formulation products, which is utilized for its research and development activities.
    To concentrate its management resources on research and development and manufacture, the Group does not hire MRs (medical representatives) or sell directly to medical institutions. Instead, for each self-developed generic drug, the Group works with a pharmaceutical manufacturer that has a powerful sales force in that particular area of efficacy of the drug and asks that manufacturer to promote and sell the drug.

Business system diagram:

Business system diagram <!-- -->
  • *1 Daito Pharmaceuticals America, Inc. was established in June 2008 originally to support the export of products of Daito Pharmaceutical Co., Ltd. to the United States. It now conducts market research.
  • *2 Daito Pharmaceutical (China) Co., Ltd. is a subsidiary of Daito Pharmaceutical Co., Ltd. acquired in September 2012 to sell pharmaceutical products in the Chinese market and to insource manufacturing of Daito’s pharmaceutical products.