Description

Teneligliptin & Metformin Sustained-Release Tablets

Healthy Inc is a specialized global supplier and exporter of advanced endocrinological, metabolic, and cardiovascular therapeutics. We provide ultra-high-purity, kinetically synchronized Teneligliptin (20 mg) & Metformin Hydrochloride (500 mg Sustained-Release) Tablets, manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Dual-Action Glycemic Control Synergy” is a massive-volume, premium export to diabetology centers, primary care networks, metabolic clinics, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally trusted, highly tolerable intervention for the management of Type 2 Diabetes Mellitus.

Product Overview

This highly advanced Fixed-Dose Combination (FDC) masterfully synchronizes Teneligliptin, a potent, third-generation Dipeptidyl Peptidase-4 (DPP-4) inhibitor, with Metformin Hydrochloride, the undisputed global gold standard biguanide insulin sensitizer.

The “Comprehensive Glycemic & Renal-Safe” Specialist:

• Mechanism 1 (The Incretin Enhancer – Teneligliptin): After a meal, the gut releases “incretin” hormones (GLP-1 and GIP) that tell the pancreas to produce insulin. Normally, the DPP-4 enzyme destroys these hormones within minutes. Teneligliptin violently blocks the DPP-4 enzyme, allowing these natural hormones to survive much longer, powerfully stimulating glucose-dependent insulin release while simultaneously suppressing glucagon (which stops the liver from dumping excess sugar).
• Mechanism 2 (The Hepatic Suppressor – Metformin): While Teneligliptin works on the pancreas, Metformin works primarily on the liver and muscles. It aggressively shuts down hepatic gluconeogenesis (the liver’s production of new glucose) and massively increases the peripheral sensitivity of muscle cells to insulin, allowing them to absorb and burn circulating glucose effectively.
• The Sustained-Release (SR) & Renal Advantage: Standard Metformin causes severe diarrhea and gastric cramping in up to 30% of patients. Our advanced Sustained-Release (SR) polymer matrix slowly leaches the Metformin into the gut over 24 hours, completely eliminating the rapid gastric spike and ensuring excellent patient compliance. Furthermore, unlike older gliptins (like Sitagliptin), Teneligliptin has a unique dual-excretion pathway (hepatic and renal), meaning it can be safely prescribed to diabetic patients with mild-to-moderate kidney disease without complex dose adjustments.

Product Composition & Strength

We supply this product as a Precision-Blended Bilayer or Matrix Sustained-Release Film-Coated Tablet, packed in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute stability of the highly hygroscopic Metformin component.

*Pack Sizes: 10×10 or 10×15 Alu-Alu Blisters (Optimized specifically for 30-day chronic endocrinology dispensing regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Metabolic Clinics, and Diabetology Networks.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Complex Matrix Kinetic Engineering: Combining a low-dose, immediate-release gliptin (20mg) with a massive, sustained-release biguanide (500mg) in a single tablet requires elite pharmaceutical formulation. Our facilities utilize advanced high-shear granulation and specialized hypromellose (HPMC) polymer matrices, verified by rigorous multipoint HPLC dissolution testing, to guarantee that the Teneligliptin disperses immediately while the Metformin slowly leaches out over 12 to 24 hours, preventing “dose dumping.”

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of severe metabolic dysfunction:

• Type 2 Diabetes Mellitus: As an adjunct to diet and exercise to improve glycemic control in adult patients with Type 2 diabetes mellitus when treatment with both Teneligliptin and Metformin is appropriate, or in patients who are inadequately controlled on Metformin monotherapy alone.

Dosage & Administration

Recommended Dosage (Strictly as per Endocrinologist/Physician Guidelines):

• Standard Adult Dosing: Typically, one tablet is taken once daily (or occasionally twice daily based on the physician’s titration protocol).
• Administration (THE MEALTIME RULE): To maximize the tolerability of the Metformin component, the tablet MUST be taken with or immediately after the evening meal.
• Swallowing Protocol (CRITICAL): Because this contains a Sustained-Release matrix, the tablet MUST be swallowed whole with a glass of water. It must never be crushed, chewed, or divided, as this will instantly destroy the extended-release mechanism, flooding the gut with Metformin and causing severe gastric distress.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Lactic Acidosis): Metformin carries a severe risk of lactic acidosis, a rare but potentially fatal metabolic complication characterized by elevated blood lactate levels, severe muscle pain, respiratory distress, and hypothermia. The risk increases significantly in patients with severe renal impairment, sepsis, or excessive alcohol intake.
• Acute Pancreatitis: All DPP-4 inhibitors (including Teneligliptin) have been associated with a risk of acute, potentially fatal pancreatitis. Patients must be counseled to stop the medication and seek emergency care if they experience severe, persistent, radiating abdominal pain.
• Hypoglycemia: While Teneligliptin and Metformin individually have a low risk of causing low blood sugar, the risk increases if co-administered with a sulfonylurea (like Glimepiride) or insulin.
• Radiologic Contrast Warning: The medication must be temporarily discontinued prior to any intravascular radiocontrast imaging procedures (like CT scans with dye) to prevent acute renal failure and subsequent lactic acidosis.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Endocrinological Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for national diabetes programs in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.