Repaglinide Tablets (0.5 mg / 1 mg / 2 mg)
Healthy Inc is a specialized global supplier and exporter of advanced endocrinological, metabolic, and chronic-care therapeutics. We provide ultra-high-purity, kinetically stabilized Repaglinide Uncoated / Film-Coated Tablets (0.5 mg / 1 mg / 2 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Short-Acting Meglitinide / Insulin Secretagogue” is a highly lucrative, massive-volume export to diabetology centers, internal medicine clinics, retail pharmacy networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, flexible-dosing intervention for the precise, meal-time glycemic management of Type 2 Diabetes Mellitus.
Product Overview
This formulation contains Repaglinide, a rapid-acting, short-duration insulin secretagogue that perfectly mimics the body’s natural physiological response to eating, specifically targeting massive blood sugar spikes immediately following a meal.
The “Post-Prandial Spike & Flexible Dosing” Specialist:
- Mechanism (The Mealtime Insulin Burst): Unlike older sulfonylureas that squeeze the pancreas all day long, Repaglinide is uniquely engineered for the exact moment food enters the body. It rapidly binds to specific receptors on the pancreatic beta cells, closing ATP-dependent potassium channels. This triggers a sudden influx of calcium, forcing a massive, immediate release of insulin. Crucially, this effect wears off within a couple of hours as the food is digested.
- The “Skip a Meal, Skip a Dose” Advantage: Sulfonylureas remain active in the blood for up to 24 hours. If a patient gets busy and skips lunch, the drug will crash their blood sugar, leading to a medical emergency. Repaglinide is fundamentally flexible: patients take it 15 minutes before a meal. If they skip the meal, they simply skip the dose. This practically eliminates the risk of severe fasting hypoglycemia, making it the preferred therapy for patients with erratic eating schedules, shift workers, or the elderly.
- The Monotherapy Champion: For patients who suffer from severe gastrointestinal intolerance to Metformin, or those with renal impairment that prevents Metformin use, standalone Repaglinide is the premier, first-line alternative to achieve rapid HbA1c control.
Product Composition & Strength
We supply this product as a Precision-Engineered Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu or heavy-density PVC/PVDC blister strips to ensure the absolute chemical stability of the highly sensitive meglitinide API.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Repaglinide USP/Ph.Eur. | 0.5 mg | Base titration unit for treatment-naive patients or those with severe renal/hepatic impairment. |
| Repaglinide USP/Ph.Eur. | 1 mg / 2 mg | Global Clinical Standard: Advanced maintenance doses for rapid post-prandial insulin stimulation. |
| Excipients | Microcrystalline Cellulose / Calcium Hydrogen Phosphate / Meglumine / Poloxamer / Magnesium Stearate | Diluent / Stabilizer / Surfactant / Lubricant (Engineered for immediate gastric dissolution and ultra-fast systemic absorption) |
*Pack Sizes: 10×10 or 3×10 Blisters (Optimized specifically for high-compliance 30-day chronic metabolic dispensing regimens tied directly to meal times).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Endocrinology Distributors, and Pharmacy Chains.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Antidiabetics) |
| CAS Number | 135062-02-1 |
| Dosage Form | Tablet (Immediate Release) |
| Packaging | Alu-Alu or High-Density PVC/PVDC Blisters. Protects the formulation from environmental humidity across Zone IVb tropical climates. |
| Storage | Store strictly below 25°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.
- Precision Micro-Dose Geometric Blending: Manufacturing a standalone 0.5 mg, 1 mg, or 2 mg dose requires elite pharmaceutical engineering. Distributing such a microscopic amount of API uniformly throughout a standard tablet matrix presents a severe blending challenge. Our facilities utilize advanced high-shear homogenizers and strict geometric dilution protocols, verified by rigorous HPLC content uniformity testing, to guarantee that every single tablet delivers the exact milligram dose, completely eliminating the risk of catastrophic hypoglycemic over-dosing or sub-therapeutic clinical failures.
Therapeutic Indications (Human Use)
Indicated for the targeted 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 Metformin or Thiazolidinediones.
- CRITICAL LIMITATION: It is strictly NOT indicated for the treatment of Type 1 Diabetes or Diabetic Ketoacidosis (DKA).
Dosage & Administration
Recommended Dosage (Strictly as per Endocrinologist Guidelines):
- Standard Adult Dosing: For patients not previously treated or whose HbA1c is < 8%, the starting dose is 0.5 mg with each meal. For patients previously treated with glucose-lowering drugs or whose HbA1c is ≥ 8%, the starting dose is 1 mg or 2 mg with each meal. The maximum recommended daily dose is 16 mg.
- Administration (THE 15-MINUTE RULE): This drug is entirely food-dependent. The tablet MUST be taken exactly 15 to 30 minutes before a meal.
- The Skipping Protocol: If a meal is skipped, the dose for that meal must be skipped. If an extra meal is added, an extra dose should be added to prevent post-prandial spiking.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Gemfibrozil & Clopidogrel Contraindication (CYP2C8 Inhibition): Repaglinide is heavily metabolized by the CYP2C8 liver enzyme. Co-administration with Gemfibrozil (a cholesterol drug) or Clopidogrel (a blood thinner) aggressively blocks this enzyme, increasing Repaglinide levels by over 800% and causing severe, prolonged, life-threatening hypoglycemia. Co-administration is strictly contraindicated.
- Hypoglycemia Risk: All insulin secretagogues can cause hypoglycemia. The risk is elevated in elderly, debilitated, or malnourished patients, and in those with adrenal or pituitary insufficiency.
- Hepatic Impairment: Repaglinide is primarily cleared by the liver. Patients with impaired liver function may be exposed to higher blood levels of the drug, necessitating severe dose reductions and careful monitoring.
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 Pharmacy Chain Supplier for 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.