Nippon Suisan Kaisha : Notice of passing eligibility examination as active pharmaceutical ingredient (API) producing facility by US Food and Drug Administration (FDA)

October 14, 2021

FOR IMMEDIATE RELEASE

Name of the Company: Nippon Suisan Kaisha, Ltd.

(Stock Code: 1332)

Listed Stock Exchange: Tokyo Stock Exchange

Representative: Shingo Hamada,

Representative Board Member,

President & CEO

Contact: Yoichiro Hiroi

General Manager,

Corporate Strategic Planning & IR Department

Telephone: [phone]

Notice of passing eligibility examination as active pharmaceutical ingredient (API)

producing facility by US Food and Drug Administration (FDA) and starting shipment of API

to United States

Nippon Suisan Kaisha, Ltd. today announces that our Fine Chemical 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 pharmaceuticals by US Food and Drug Administration (FDA) and have started shipping API to United States. Please see the attached sheet for details.

If it is found that this matter will have a significant impact on business results, we will promptly disclose it.

October 14, 2021

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

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 (*

1. 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.

Fine Chemicals General Factory

Kashima Pharmaceutical Factory

Completed on May 11, 2017

* 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.

1

Based on the data of 2021 Global EPA and DHA Omega-3 Ingredient Market Report by GOED (The Global Organization for EPA and DHA Omega-3), a graph was created with the sales volume of pharmaceutical raw materials in 2018 as 100.

* 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)

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