[의학신문·일간보사=김영주 기자]Myungin Pharmaceutical will enter the Japanese drug substance market in earnest.
Myungin Pharm announced that its own synthetic drug substance’Triazolam’ has been approved by the Pharmaceuticals and Medical Devices Agency (PMDA), a drug and medical device registration and management agency under the Ministry of Health, Labor and Welfare of Japan, and has completed J-DMF registration.
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| View of Myeongin Pharmaceutical’s Balan Plant |
‘Triazolam’ (trade names: Halcion tablet, Zolmin tablet, etc.) is a drug used for the treatment of insomnia. It is also designated as a psychotropic drug in Korea and Japan, making import and export procedures very difficult. Psychotropic drug raw materials are more strictly managed in terms of specifications and quality than general pharmaceutical raw materials.
This is the first time that a domestically synthesized psychotropic drug ingredient has been registered in Japan’s J-DMF, and Myeongin Pharmaceutical’s ingredients will be supplied to products currently sold as finished products by four Japanese pharmaceutical companies.
Earlier in February of last year, Myeongin Pharmaceutical announced that its Balan synthesis plant, its raw material synthesis plant, obtained the Acceditation Certificate of Foreign Drug Manufacturer (AFM) from the Ministry of Health, Labor and Welfare of Japan. Japan is an important drug exporter in the domestic pharmaceutical industry, and Myungin Pharmaceutical has already exported Hydrocortisone injection, a freeze-dried injection, to Japan since 2017, and plans to export products equivalent to 2 million vials this year. In addition, it is expanding its business to develop additional raw materials for export other than’Triazolam’ with Japanese pharmaceutical companies.
Chairman Lee Haeng-myeong of Myungin Pharmaceutical said, “As we export the raw materials of’Triazolam’ to Japan, we are expected to be recognized for the excellence of the quality of the products produced at the Balan Synthetic Plant and increase the company’s reliability. The company plans to further accelerate its entry into the Japanese drug substance market by continuously expanding its export raw material business.”
Reporter Kim Young-joo [email protected]
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