Manufacturing

GL Pharm Tech Corp. Obtains Approval for Three Dosage Forms of the World’s First Rosuvastatin and Ezetimibe Oral Disintegrating Tablets

[Edaily Reporter SHIN MIN JOON ] GL Pharm Tech Corp.(204840), a company specializing in pharmaceutical R&D, has received the world’s first marketing authorization for a rosuvastatin/ezetimibe combination orally disintegrating tablet.

GL Pharm Tech Corp. CI. (Image courtesy of GL Pharm Tech Corp.)

GL Pharm Tech Corp. announced on the 23rd that its subsidiary, GL Pharma, had obtained marketing authorization from the Ministry of Food and Drug Safety for “Lobaeljet” oral disintegrating tablets—a rosuvastatin and ezetimibe combination therapy for hypercholesterolemia—in three different strengths.

This approval marks the first-ever global approval of a rosuvastatin-ezetimibe combination oral disintegrating tablet and is expected to offer new convenience in medication adherence to the dyslipidemia treatment market, which has traditionally been dominated by tablet formulations.

Lobaeljet Orally Disintegrating Tablets are a combination drug that combines rosuvastatin, a statin, and ezetimibe, a cholesterol absorption inhibitor, into a single formulation. They were developed to rapidly disintegrate in the mouth without the need for water.

The market for dyslipidemia treatments in South Korea is estimated to be a large market worth approximately 1.4 trillion won. Dyslipidemia is considered one of the major risk factors for atherosclerotic cardiovascular disease. According to 2022 data from the Korean Society of Lipid and Atherosclerosis, approximately 40.2% of South Korean adults aged 20 and older have dyslipidemia.

This newly approved product incorporates MTTM (Multiple-Time Taste Masking), a proprietary platform technology developed by W Science, the parent company of GL Pharm Tech Corp. Since orally disintegrating tablets are taken without water, the bitter taste of the active ingredient can affect patient compliance.

MTTM technology is a platform technology that masks the bitter taste during the drug’s dissolution in the mouth. By effectively reducing the bitter taste that can occur from the moment the tablet is placed in the mouth until just before swallowing, it improves patient convenience.

GL Pharm Tech Corp. is currently undergoing a small-scale merger with its wholly-owned subsidiary, GL Pharma. Once the merger is complete, the company expects to accelerate the development of high-potential products through enhanced management efficiency.

GL Pharm Tech Corp. official stated, “Obtaining the world’s first marketing authorization for Lovaeljet Orally Disintegrating Tablets is an achievement that goes beyond a simple product launch; it demonstrates our formulation platform technology and R&D capabilities.” The official added, “Using this product as a springboard, we will expand the development of improved new drugs based on the MTTM platform and continuously secure core pipelines to grow into Korea’s leading developer of improved new drugs.”

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