Active Pharmaceutical Ingredients (APIs) play a key role in the pharmaceutical industry and are the primary basis for the manufacture of all pharmaceuticals.

The market size of the Japanese pharmaceutical industry ranks second in Asia. With the increase in R&D expenditure of the pharmaceutical industry and other reasons, it is expected that the Japanese APIs market will grow at a relatively high rate of 7% to 8% by 2025. Among them, pharmaceutical companies that have played a significant role include Sun Pharmaceutical, Teva, Novartis International AG, Piramal Enterprises, and Aurobindo.

The development of Japan’s generic drug industry is also facing the obstacle of insufficient independent supply of raw materials. Nearly 50% of its domestic imports of APIs are used for the production of generic drugs, and the main international suppliers come from Asian and European countries such as India, China, South Korea, Italy, Spain, Hungary and Germany. In order to reduce the dependence on imported APIs, Japan is focusing on the localization of APIs.

Sumitomo Pharmaceuticals, the first company in Japan to produce chemical drugs using advanced organic synthesis technology, plans to build a new small molecule drug APIs and intermediates factory in Oita City, Oita Prefecture. The main goal of the project is to increase the company’s API production capacity potential to meet the growing demand for high-quality APIs and intermediates.

The new plant is scheduled to be put into operation in September 2024. Its contract development and manufacturing (CDMO) department uses unique technology to produce and supply small molecule APIs and intermediates for formulation companies, and realize external commercial sales. Due to the strong demand for new drug development projects, the world pharmaceutical CDMO market has maintained continuous growth. It is estimated that the current global commercial value of CDMO medicine is about 81 billion US dollars, equivalent to 10 trillion yen.

Relying on its excellent quality assurance system and global supply chain management advantages, Sumitomo Pharmaceuticals has gradually expanded its CDMO business over the years and has established a leading position in Japan. Its plants in Gifu and Okayama have small production capacity. Strong production capacity of APIs and intermediates required for molecular therapeutic drugs. Japanese pharmaceutical contract manufacturer Bushu Corporation reached a cooperation agreement with Suzuken Pharmaceutical Company in April 2021 to provide new product development support for professional pharmaceutical companies intending to enter the Japanese market. Bushu hopes to carry out a cooperation agreement for domestic direct production of APIs, through the cooperation of the two pharmaceutical companies, to provide one-stop management services for the demand for special drugs, including the promotion of authorization holders/drug holders transfer consultation, import, market evaluation, Production and supply, entrusted storage and transportation, promotion evaluation and patient assistance and other services.

At the same time, Bushu Pharmaceuticals can safely deliver drugs to patients throughout the entire process by using the special drug micro-cold chain monitoring system (Cubixx) developed by Suzuken Co., Ltd. In addition, Japan’s Astellas Pharmaceutical Company disclosed that according to the third production expansion plan, the API base for the production of fixed-function drugs established in Toyama, Japan in January 2020 will be used to manufacture the original Astellas Prograf’s tacrolimus hydrate API.

Tacrolimus is a drug that prevents and treats organ rejection in adult and pediatric patients who have received liver, kidney, heart (and lung new FDA approval in 2021) transplants.

article source: https://www.shlzpharma.com/news/insufficient-self-sufficiency-of-raw-materials-in-japan/

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