Description
Teneligliptin Tablets (20 mg)
Healthy Inc is a specialized global supplier and exporter of advanced endocrinological, metabolic, and cardiovascular therapeutics. We provide ultra-high-purity, precision-engineered Teneligliptin Hydrobromide Hydrate Tablets (20 mg), manufactured in WHO–GMP certified, high-capacity oral solid dosage facilities. This “Third-Generation DPP-4 Inhibitor” 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, and renal-safe intervention for the management of Type 2 Diabetes Mellitus.
Product Overview
This formulation contains Teneligliptin, a structurally unique, “J-shaped” dipeptidyl peptidase-4 (DPP-4) inhibitor that provides powerful, continuous, 24-hour glycemic control with a single daily dose.
The “Incretin Enhancer & Renal-Safe” Specialist:
- Mechanism (The DPP-4 Blockade): Normally, the gut releases incretin hormones (like GLP-1) after eating to trigger insulin release. However, the body’s DPP-4 enzyme destroys these hormones within minutes. Teneligliptin binds aggressively to the DPP-4 enzyme and neutralizes it. This allows the natural incretin hormones to survive and circulate much longer, forcing the pancreas to secrete insulin precisely when blood sugar is high (glucose-dependent), while simultaneously stopping the liver from dumping excess glucagon.
- The “Renal-Safe” Clinical Advantage: The defining feature of Teneligliptin compared to older gliptins is its unique dual route of elimination. It is metabolized and excreted evenly through both the liver and the kidneys. Because of this, no dose adjustment is required for patients with mild, moderate, or severe renal impairment, or even those on end-stage renal dialysis. This massively simplifies prescribing protocols for endocrinologists treating older, medically complex diabetic patients.
- Weight-Neutral & Hypoglycemia-Safe: Unlike older sulfonylureas (like Glimepiride) that force insulin out regardless of blood sugar levels—causing dangerous hypoglycemic crashes and weight gain—Teneligliptin only works when blood sugar is actively elevated, making it incredibly safe and completely weight-neutral.
Product Composition & Strength
We supply this product as a Precision-Blended Film-Coated Tablet, packed in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute stability of the active pharmaceutical ingredient across diverse tropical and high-humidity climates.
| Active Ingredient | Strength | Primary Clinical Use |
|---|---|---|
| Teneligliptin Hydrobromide Hydrate INN | 20 mg | Standard Global Dose: Once-daily therapy for glycemic control in Type 2 Diabetes. |
| Excipients | Microcrystalline Cellulose / Mannitol / Croscarmellose Sodium / Magnesium Stearate | Diluent / Superdisintegrant (Engineered for immediate gastric dissolution and rapid absorption) |
*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.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Antidiabetics) |
| CAS Number | 902456-69-7 (Teneligliptin) |
| Dosage Form | Film-Coated Tablet (Immediate Release) |
| Packaging | Alu-Alu Blisters (CRITICAL). Essential for protecting the sensitive API from hydrolytic degradation during global transit and pharmacy storage in Zone IVb climates. |
| Storage | Store strictly below 30°C in a dry place. Protect from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Low-Dose Uniformity Engineering: Delivering a potent 20 mg active ingredient within a standard tablet matrix requires elite pharmaceutical blending. Our facilities utilize advanced high-shear homogenizers and strict geometric dilution protocols, verified by HPLC assay testing, to guarantee that every single tablet delivers flawless kinetic release, ensuring stable 24-hour glycemic coverage without peak-and-trough volatility.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of metabolic dysfunction:
- Type 2 Diabetes Mellitus: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It can be used as monotherapy or in combination with other antidiabetic agents (like Metformin, Pioglitazone, or Glimepiride) when those agents do not provide adequate glycemic control.
Dosage & Administration
Recommended Dosage (Strictly as per Endocrinologist/Physician Guidelines):
- Standard Adult Dosing: The usual dose is 20 mg administered orally once daily. If efficacy is insufficient, the dose may be increased up to 40 mg once daily under strict medical supervision.
- Administration: Highly flexible; can be taken at any time of the day, with or without food.
- Renal & Hepatic Impairment: No dose adjustment is required for patients with any degree of renal impairment. No dose adjustment is required for mild-to-moderate hepatic impairment.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Acute Pancreatitis: Like all DPP-4 inhibitors, Teneligliptin has been associated with rare but potentially fatal cases of acute pancreatitis. Patients must be counseled to stop the medication and seek emergency care if they experience severe, persistent, radiating abdominal pain (with or without vomiting).
- Severe Arthralgia (Joint Pain): The FDA and global regulators have warned that DPP-4 inhibitors can cause severe, debilitating joint pain that may occur from one day to years after starting therapy. Symptoms usually resolve upon discontinuation of the drug.
- Heart Failure Risk: While Teneligliptin generally has a favorable cardiovascular profile, certain drugs in the DPP-4 class (like Saxagliptin) have been associated with an increased risk of heart failure hospitalizations. Caution should be exercised in patients with a known history of congestive heart failure.
- QTc Prolongation: At doses higher than the standard 20mg (specifically 40mg or above), Teneligliptin has the potential to slightly prolong the QTc interval. It should be used with caution in patients prone to arrhythmias.
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.









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