Contract Manufacturing of Pharmaceutical APIs and Intermediates

Contract Manufacturing of Pharmaceutical APIs and Intermediates

The contract manufacturing business for pharmaceutical APIs and intermediates involves pharmaceutical development companies outsourcing the manufacturing process to specialized external companies instead of owning their manufacturing facilities. This business model enables resource efficiency, cost reduction, and risk distribution in the pharmaceutical industry, which requires high capital investment, operational costs, and strict regulatory compliance.

APIs (Active Pharmaceutical Ingredients) are the main components responsible for the effect of pharmaceuticals, and intermediates are compounds produced during the manufacturing process of these APIs.

Compliance with GMP (Good Manufacturing Practice) Standards

The manufacturing of pharmaceutical APIs and intermediates is carried out under strict management systems compliant with GMP (Good Manufacturing Practice) standards. Manufacturing process development is conducted at each stage from preclinical to commercial production. The facility covers a site area of approximately 118,892 m² (about 36,000 tsubo), with a building area of about 12,000 m², production facilities of about 4,300 m², warehouse facilities of about 4,600 m², and a green area of about 52,400 m², providing ample space for future development.

Compliance with GMP (Good Manufacturing Practice) Standards

KIYAN PHARMA Business Overview

5-ALA Manufacturing Business

Manufacturing 5-ALA for pharmaceuticals, health foods, cosmetics, fertilizers, and feed, according to required quality standards.

Contract Manufacturing of Pharmaceutical APIs and Intermediates

The Fukuroi Plant is expanding contract manufacturing of pharmaceutical APIs and intermediates, in addition to 5-ALA.

Health Food & Cosmetics Business

Supporting consumer beauty and health with supplements and skincare products containing 5-ALA.

Fertilizer, Feed & Animal Health Business

Developing and providing products that contribute to animal health maintenance and plant growth promotion using 5-ALA.

Drug Development & Licensing Business

Developing new drugs for infectious and lifestyle-related diseases, and expanding licensing businesses.

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