[Edaily Reporter SHIN MIN JOON ] GL Pharm Tech Corp.(204840)announced that its subsidiary, GL Pharma, has obtained marketing authorization from the Ministry of Food and Drug Safety for the antihypertensive combination drug Telmieltan Tablets. With this approval, GL Pharm Tech Corp. will continue to expand its product portfolio in the field of chronic cardiovascular diseases, including hypertension.

GL Pharm Tech Corp. launched Liriel Orally Disintegrating Tablets and Proen Soft Gel Capsules in the first half of this year. Following the marketing authorization for Lovael Jet Orally Disintegrating Tablets, GL Pharm Tech Corp. is further accelerating the development of differentiated new products with the approval of Telmieltan Tablets.

Telmiel Tablets are a fixed-dose combination medication for hypertension that combines telmisartan, an angiotensin II receptor blocker, with esamlodipine, a calcium channel blocker. The approved product is available in four strengths: 40/2.5 milligrams (mg), 40/5 mg, 80/2.5 mg, and 80/5 mg. By securing all major therapeutic dosages, GL Pharm Tech Corp. has enabled patients to select the appropriate strength based on their blood pressure control status and current dosage.

Telmieltan Tablets are expected to be the first generic version to enter the actual reimbursement market for the original product, CHONGKUNDANG’s Telminuvo Tablets. Previous generic versions had received product approval and priority marketing authorization. However, this did not lead to inclusion in the national health insurance drug price list or actual product supply. Consequently, the telmisartan-amlodipine combination market has long been dominated by Telminuvo Tablets.

Telmi-Eltan Tablets are a two-layer tablet formulation, which is highly challenging to develop, as telmisartan has low solubility and complex dissolution characteristics. In contrast, esamlodipine is considered an ingredient for which ensuring stability during manufacturing and storage is critical. To develop a single tablet, it is necessary to simultaneously ensure the dissolution of telmisartan and the stability of esamlodipine while minimizing the interaction between the two ingredients.

GL Pharm Tech Corp. established a two-layer tablet formulation and manufacturing process that separates the two ingredients into distinct layers, achieving consistent dissolution profiles and quality equivalence across four dosage strengths. This achievement is regarded as proof of the company’s capability to develop highly complex combination drugs, as it successfully overcame manufacturing challenges involving inter-layer separation and the management of weight and content variations.

Once Telmieltan Tablets are listed in the national drug price database, they will become the first generic drug to be supplied under national health insurance coverage, regardless of the order of approval. This is also significant in that it provides a stable alternative treatment option to the original product, which was previously the sole supplier. GL Pharm Tech Corp. plans to supply Telmieltan Tablets to the market this October by swiftly proceeding with insurance price listing and production and distribution preparations.

GL Pharm Tech Corp. official stated, “These recent achievements demonstrate that our R&D capabilities—which have consistently addressed product-specific formulation challenges such as oral disintegration, bitter taste masking, and the separation and stabilization of complex ingredients—are now leading to commercialization,” adding, “We will continue to introduce products that prioritize patient convenience and address unmet needs in clinical practice.”