Gliclazide Tablets
Healthy Inc is a specialized global supplier and exporter of advanced metabolic control agents. We provide high-purity Gliclazide Tablets (Immediate Release and Modified Release), sourced from WHO–GMP certified solid dosage facilities. This “Vascular-Protective” Sulfonylurea is a top export to diabetic care centers, government health formularies, and pharmacy chains in Africa, LATAM, and Southeast Asia, serving as the preferred oral hypoglycemic agent for Type 2 diabetics who require strict glycemic control with minimal risk of hypoglycemia.
Product Overview
This formulation contains Gliclazide, a second-generation sulfonylurea with unique hemovascular properties.
The “Safe & Protective” Specialist:
- Mechanism: Gliclazide stimulates the beta cells of the pancreas to release insulin. Uniquely, it restores the **”First Phase” insulin peak**—the rapid burst of insulin that occurs immediately after eating. This mimics the body’s natural response to food, effectively controlling post-prandial (after-meal) sugar spikes.
- Hemovascular Properties: Beyond blood sugar, Gliclazide inhibits platelet aggregation and increases fibrinolytic activity. This reduces the formation of micro-clots (thrombosis), offering protection against the microvascular complications of diabetes (retinopathy and nephropathy).
- Free Radical Scavenging: It contains an azabicyclo-octyl ring which acts as a free radical scavenger, reducing oxidative stress on the beta cells and slowing their burnout.
- Safety Profile: Unlike Glibenclamide, Gliclazide has a shorter half-life and lower affinity for cardiac receptors, resulting in a significantly lower risk of severe, prolonged hypoglycemia and better cardiovascular safety.
Product Composition & Strength
We supply this product as Uncoated Tablets (Immediate Release) or Modified Release (MR) Tablets (Once Daily).
| Active Ingredient | Strength | Formulation | Role |
|---|---|---|---|
| Gliclazide BP/EP | 80 mg | Immediate Release | Standard Divided Dose |
| Gliclazide BP/EP | 30 mg | Modified Release (MR) | Once Daily (Start) |
| Gliclazide BP/EP | 60 mg | Modified Release (MR) | Once Daily (Maintenance) |
| Excipients | Q.S. | HPMC (Matrix) / Lactose | Release Control |
*Pack Sizes: Blister packs of 10s (Box of 10×10), 15s, 30s (Calendar Pack), or Bulk HDPE Jars of 1000s.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Tablet (Uncoated / MR) |
| Packaging | PVC-Alu Blister or Alu-Alu Blister |
| Storage | Store below 25°C. Keep dry. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- MR Matrix Technology: The Modified Release tablets utilize a hydrophilic matrix (HPMC). Upon contact with GI fluids, the tablet forms a gel barrier that releases the drug progressively over 24 hours. This aligns insulin release with the circadian rhythm of glucose levels, preventing both spikes and drops.
- Dissolution Testing: We perform rigorous multi-point dissolution testing (e.g., at 2h, 6h, and 12h) on MR batches to guarantee the release profile matches the innovator (Diamicron MR).
Therapeutic Indications (Human Use)
Indicated for the treatment of Type 2 Diabetes Mellitus:
- Adult Onset Diabetes: Used when dietary measures, physical exercise, and weight loss alone are not sufficient to control blood glucose.
- Microvascular Protection: Preferred in patients with early signs of retinopathy or nephropathy due to its anti-platelet effects.
Dosage & Administration
Recommended Dosage (Strictly as per Endocrinologist):
- Route: Oral.
- Modified Release (30-120 mg):
- Start with 30 mg once daily at breakfast.
- If needed, increase to 60 mg, 90 mg, or 120 mg once daily.
- Swallow whole; do not crush or chew.
- Immediate Release (80-320 mg):
- Usually 40 mg to 80 mg twice daily.
- Max dose 320 mg daily (in divided doses).
- Timing: MUST be taken with breakfast. Skipping the meal after taking the tablet can lead to hypoglycemia.
Safety Warnings:
- Hypoglycemia: While safer than Glibenclamide, it can still cause low blood sugar, especially if meals are skipped, alcohol is consumed, or exercise is intense.
- Weight Gain: Can cause moderate weight gain.
- Drug Interactions: Effects are potentiated by Miconazole (oral gel), Phenylbutazone, and Alcohol (Antabuse effect). Effects are reduced by Corticosteroids.
- Renal Failure: Generally safe in mild-to-moderate renal impairment, unlike many other sulfonylureas.
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 Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for OSD (Oral Solid Dosage) forms, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement 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.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in