News Release
HighChem Enhances Pharmaceutical Exports to China and Strengthens Presence in the Generic Drug Sector
HighChem Company Limited (Head office: Minato-ku, Tokyo President and CEO: Ushio Taka hereinafter referred to as HighChem) will expand its pharmaceutical business by strengthening its exports of pharmaceutical ingredients and formulations to China and its handling of generic drugs.
Strengthening export business of highly difficult pharmaceutical products from Japan to China
HighChem is strengthening its export business of pharmaceutical ingredients and formulations from Japan to China. In September 2021, one of the products handled by HighChem was approved by the Chinese authorities (National Medical Products Administration, NMPA) and sales began in the Chinese market. Additionally, as of July 2022, there are 5 products registered with the Center for Drug Review and Evaluation (CDE), and we expect 1 to 2 additional products to be approved and sold in the Chinese market within 2022. Furthermore, as awareness of the pharmaceutical export business to China has expanded within the industry, we have prepared initial requirements and application materials for an additional 4 to 5 items.
Although high-quality Japanese active pharmaceutical ingredients and formulations are popular in China, the application documents and systems are difficult to understand, creating a bottleneck for Japanese companies expanding into China. HighChem has been conducting market research and sales support for products in China since 2014, and has accumulated know-how. In addition, we have pharmacist license holders both in China and Japan, so we can act on behalf of those in need to apply in accordance with the laws and regulations of both countries and support export procedures for products.
Providing integrated services from process development to commercial production of generic drug candidate drug substances
HighChem is actively importing active pharmaceutical ingredients (APIs) for medical, over-the-counter (OTC), and veterinary uses, as well as pharmaceutical intermediates from China. The company also offers integrated services ranging from process development to commercial production for hard-to-source generic drug APIs. Recently, HighChem has developed capabilities to handle more complex products, including the development of crystallization techniques to obtain crystal forms that do not infringe on patented polymorphs by other companies, from laboratory scale to commercialization. This enhancement of services ensures that HighChem can meet the increasing challenges and demands of the pharmaceutical industry.
An example of a developed drug
・Psoriasis vulgaris treatment drug “Apremilast” (generic name)
・Diabetes treatment drug “dapagliflozin” (generic name)
HighChem Company Limited Overview
Company Name: HighChem Company Limited
Location: Minato-ku, Tokyo 3-1, Toranomon 1-chome, Tokyo Toranomon Global Square 11F
Representative Director： Taka Ushio
Business： Export/import and sales of Chemicals / outsourced manufacturing / Technology Licensing related business / manufacture and sales of catalysts / Biodegradable Materials import and sales, etc.
Media inquiries regarding this release
HighChem Co., Ltd. PR Division – Eriko Kuroiwa
E-mail: kuroiwa@highchem.co.jp Phone: +81-3-5251-8580 / +81-90-6539-4213 (Kuroiwa)