Started shipping pure EPA active pharmaceutical ingredient (API) to United States

2021/10/14

Nippon Suisan Kaisha, Ltd. (President and CEO Shingo Hamada, Minato-ku, Tokyo, hereinafter "Nissui") announces that our Fine Chemicals General Factory Kashima Pharmaceutical Factory (Kamisu City, Ibaraki Prefecture) and Tsukuba Factory (Tsukuba City, Ibaraki Prefecture) have passed the eligibility examination as API producing facility for pure EPA (* 1) pharmaceuticals (* 2) by US Food and Drug Administration (FDA), and have started shipping API to United States. It is expected that the production and sales of pure EPA pharmaceuticals in the United States will expand in the future, and both factories will prepare a system to expand shipments.

* 1 EPA (eicosapentaenoic acid)
One of the components contained in fish oil such as sardines, and a type of omega-3 essential fatty acid. Various effects such as reduction of heart disease risk, reduction of triglyceride in blood, and anti-inflammatory have been observed. In Japan, EPA was approved as pharmaceuticals for arteriosclerosis obliterans in 1990 and hyperlipidemia in 1994.
Nissui grasped its usefulness through an epidemiological survey of EPA, which was started in 1980 with Chiba University, and after joint development of the drug with Mochida Pharmaceutical, it reached the approval as pharmaceuticals in 1990. We have also developed advanced refining technology and succeeded in producing pure EPA for the first time in the world.

* 2 pure EPA pharmaceuticals
It is a pharmaceutical product with an EPA purity of 96.5% or higher.
In Japan, hyperlipidemia is a target disease. In addition to this, in United States, an application to high-risk patients with multiple risk factors for cardiovascular diseases and other cardiovascular diseases who are using statins (* 3) with blood triglyceride levels of 150 mg / dL or higher was approved by the FDA in 2019.
The number of patients receiving statin prescriptions in the United States is estimated to be 38 million.

* 3 Statins

It is a pharmaceutical product that lowers cholesterol and has the effect of preventing the onset of cardiovascular diseases such as myocardial infarction and cerebral infarction.

[Fine Chemicals General Factory Kashima Pharmaceutical Factory Overview]
Location: 18-2 Higashifukashiba, Kamisu City, Ibaraki Prefecture
Factory total floor area: 3,708㎡
Number of employees: 45 (as of September 2021)

[Fine Chemicals General Factory Tsukuba Factory Overview]
Location: Techno Park Oho, 7 Okubo, Tsukuba City, Ibaraki Prefecture
Factory total floor area (pharmaceutical department): 999㎡
Number of employees (pharmaceutical department): 40 (as of September 2021)

End of Document