Overseas Business
- Top
- Businesses
- Overseas Business
Global Business Expansion
We export active pharmaceutical ingredients (APIs) and formulation products to the U.S. and European and Asian countries. We currently export mainly APIs, but we will increase the export of generic products from now on. We aim to further expand our business globally by optimizing our manufacturing system and leveraging our capability to manufacture high-quality products at a low cost.
Domestic and International Networks
U.S.:Daito Pharmaceuticals America, Inc.
Businesses
Daito Pharmaceuticals America, Inc. (DPA) was founded as a Daito subsidiary in Illinois, the U.S., in 2008. As an important base for the Daito Group’s expansion into the U.S. (North American) market, the company is now mainly conducting surveys in preparation for the export of APIs and other materials and market expansion.
Current business activities
The company is currently preparing to obtain approval for the marketing of the first Daito formulation product in the U.S. DPA staff are also conducting activities to select other candidate products for launch into the U.S. market.
Activity progress
- Obtained ANDA approval for 2 compounds
* An Abbreviated New Drug Application (ANDA) is an application to be submitted to the U.S. Food and Drug Administration (FDA) to obtain approval for the marketing of a generic drug in the U.S.
China: Daito Pharmaceutical (China) Co., Ltd.
Business / Business development
As a base for the manufacture of formulation products in China, Daito Pharmaceutical (China) Co., Ltd. manufactures formulation products for the Japanese market on a contract basis.
We are striving to expand into the Chinese market with Daito Pharmaceutical’s products by maintaining the same quality level as in Japan and taking advantage of lower manufacturing costs in China.
As a basis for the manufacture of products to be provided to China, ASEAN countries and other regions, the company is proactive in business expansion into overseas growth markets.
Efforts to Optimize the Daito Group’s Manufacturing System
Daito Pharmaceuticals America, Inc. (DPA) was founded as a Daito subsidiary in Illinois, the U.S., in 2008. As an important base for the Daito Group’s expansion into the U.S. (North American) market, the company is now mainly conducting surveys in preparation for the export of APIs and other materials and market expansion.
APIs
APIs are manufactured by Daito Pharmaceutical Co., Ltd., Daiwa Pharmaceutical Co., Ltd., a subsidiary of Daito, and two Daito affiliated companies in China: Cheer Fine Pharmaceutical Co., Ltd. and Anhui Tingworld Pharmaceutical Co., Ltd.
Formulation products
Formulation products are manufactured by Daito Pharmaceutical Co., Ltd. and Daito Pharmaceutical (China) Co., Ltd., a subsidiary of Daito.
Other Regions
Current business activities
We are expanding our business into 12 countries, including ASEAN and European countries, for example, by collecting additional stability test*1 data (including data from Zone IVb*2) in anticipation of exporting Daito products to various countries.
In partnership with various parties around the world, we are making a full commitment to expanding global markets and strengthening our supply chain by complying with pharmaceutical regulations and sales procedures (such as government bidding) in various countries and selecting appropriate products for export.
Conducting business expansion activities in
12 countries
in the world as of February 2022
- ASEAN region: Philippines, Vietnam (application submitted; bidding) and Indonesia
- India
- Europe: Germany, Netherlands, Italy, Switzerland and Slovakia
- South Korea
- Taiwan (selling formation products)
- Middle East: Iraq (government bidding)
- Stability tests are conducted to monitor changes in the quality of pharmaceutical products over time under the influence of temperature and humidity.
- The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines divide the world into four climate zones (Zones I to IV) and define conditions for stability testing in each of the zones. Zone IVb is of the “hot/higher humidity” type of climate.