Description

Repaglinide & Metformin Tablets (1 mg / 500 mg & 2 mg / 500 mg)

Healthy Inc is a specialized global supplier and exporter of advanced endocrinological, metabolic, and chronic-care therapeutics. We provide ultra-high-purity, kinetically synchronized Repaglinide & Metformin Hydrochloride Film-Coated Tablets (1mg/500mg & 2mg/500mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Meglitinide & Biguanide Dual-Action FDC” 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 glycemic management of Type 2 Diabetes Mellitus.

Product Overview

This highly advanced Fixed-Dose Combination masterfully synchronizes a rapid-acting, short-duration insulin secretagogue with a baseline hepatic glucose suppressor, delivering complete, 24-hour glycemic coverage that specifically targets massive blood sugar spikes after eating.

The “Post-Prandial Spike & Flexible Dosing” Specialist:

• Mechanism 1 (The Mealtime Insulin Burst – Repaglinide): When a diabetic patient eats a heavy meal, their blood sugar spikes violently (post-prandial hyperglycemia). Repaglinide is uniquely engineered for this exact moment. It rapidly closes ATP-dependent potassium channels in the pancreas, forcing a massive, immediate release of insulin. Crucially, this effect wears off within a few hours, perfectly mimicking a healthy pancreas’s natural response to food.
• Mechanism 2 (The Fasting Glucose Suppressor – Metformin 500mg): While Repaglinide handles the meal, Metformin handles the baseline. It aggressively shuts down the liver’s overproduction of glucose (gluconeogenesis) overnight and makes the body’s muscle tissues highly sensitive to the insulin that Repaglinide just produced, drastically lowering fasting blood glucose and HbA1c.
• The “Skip a Meal, Skip a Dose” Advantage: Older diabetes drugs (Sulfonylureas) stay in the blood all day. 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 or shift workers.

Product Composition & Strength

We supply this product as a Precision-Engineered Film-Coated 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 combined formulation.

*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.

Manufacturing Authority

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

• Extreme Ratio Geometric Dilution Engineering: Manufacturing an FDC that combines a microscopic 1 mg or 2 mg dose of Repaglinide with a massive 500 mg block of Metformin presents a severe blending challenge. Our facilities utilize advanced high-shear fluid-bed granulation and strict, multi-stage geometric dilution protocols. This is rigorously verified by high-frequency HPLC content uniformity testing to guarantee that the tiny Repaglinide API is flawlessly and evenly distributed throughout every single tablet, preventing catastrophic localized over-dosing or sub-therapeutic failures.

Therapeutic Indications (Human Use)

Indicated for the targeted management of complex metabolic dysfunction:

• Type 2 Diabetes Mellitus: As an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes whose hyperglycemia cannot be controlled by diet and exercise plus Metformin or a Meglitinide alone, or who are already treated with both drugs concurrently.
• 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: Usually initiated at 1 mg/500 mg taken twice or three times daily, depending on the patient’s current glycemic status. The maximum daily dose of Repaglinide should not exceed 16 mg, and Metformin should not exceed 2000 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):

• BLACK BOX WARNING (Lactic Acidosis – Metformin): Post-marketing cases of Metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. This severe metabolic complication is triggered by conditions that cause tissue hypoxia or renal impairment.
• Radiological Contrast Dye Discontinuation: The medication must be temporarily halted before any intravascular radiocontrast imaging procedures (like CT scans with dye), as the dye can cause acute renal failure, rapidly triggering fatal Lactic Acidosis.
• Gemfibrozil & Clopidogrel Contraindication (CYP2C8 Inhibition): Repaglinide is heavily metabolized by the CYP2C8 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.
• Renal Impairment: Contraindicated in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2).

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.