Description

Glibenclamide Tablets (2.5mg / 5mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Glibenclamide Tablets in India. Also known as Glyburide in the US, Glibenclamide is a potent Second-Generation Sulfonylurea used for the management of Type 2 Diabetes Mellitus. It works by stimulating the pancreas to release more insulin, making it a highly effective agent for patients who are not overweight and whose diabetes cannot be controlled by diet alone.

We offer Contract Manufacturing (Third Party) services for this cornerstone antidiabetic. Glibenclamide has poor water solubility, which can lead to variable absorption. Our WHO-GMP certified facility in Mumbai utilizes Micronization Technology (reducing particle size to < 5 microns) to ensure consistent bioavailability and uniform blood sugar control. Healthy Inc manages the export logistics, supplying government tenders and pharmacy chains across Africa, the Middle East, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Micronization for reliable sugar control.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Micronized API: Regular Glibenclamide is poorly absorbed. We use exclusively Micronized grade API. This increases the surface area, ensuring the drug dissolves predictably in the gut. If the particle size is too large, the drug may not work; if too small, it might cause sudden hypoglycemia. We control this strictly.

  • Content Uniformity: Glibenclamide is potent at low doses (2.5mg). We use automated high-shear granulation to ensure a perfect mix, preventing “hot spots” in the batch that could lead to dangerous overdoses in a single tablet.

  • Direct Compression: For specific markets, we use direct compression grades to improve stability and dissolution profiles.

• The Exporter: Healthy Inc

  • Market-Specific Branding: We can manufacture the tablet in various shapes (semi-scored, flat) and colors (Pink for 5mg is a common standard) to match local market leader branding for easy patient switching.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >70% of the drug releases within 45 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We strictly monitor for sulfonamide impurities (Sulfonamide and Cyclohexylisocyanate) to ensure safety.

5. Why Use Glibenclamide?

It squeezes the pancreas to release insulin.

• Mechanism: Glibenclamide acts on the Beta Cells of the pancreas. It binds to the Sulfonylurea Receptor (SUR1) on the ATP-sensitive potassium channel. This closes the channel, causing the cell to depolarize. This opens calcium channels, causing an influx of calcium which triggers the exocytosis (release) of Insulin granules into the bloodstream.

• Key Indications:

  • Type 2 Diabetes: Used when diet and exercise fail. Often effective in non-obese patients.

  • Combination Therapy: Often combined with Metformin (which works on the liver/muscles) for a dual attack on high blood sugar.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Glibenclamide Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Daonil?

  A: Daonil is the brand name (Sanofi). We manufacture the Generic Equivalent (Glibenclamide), which acts exactly the same.

• Q: Does it cause low blood sugar?

  A: Yes. Hypoglycemia is the most common side effect, especially if you skip a meal or exercise heavily. Always carry sugar/candy.

• Q: Does it cause weight gain?

  A: Yes. Because it increases insulin (which stores fat), some weight gain is common. It is often prescribed with Metformin to balance this out.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Starting Dose: 2.5mg or 5mg daily with breakfast.

• Maintenance: Adjustable up to 10mg or 15mg daily (divided doses).

• Administration: Must be taken with the first main meal of the day to prevent hypoglycemia.

9. Side Effects and Precautions

• Hypoglycemia: Warning: Can be severe and prolonged. Elderly patients are at higher risk.

• Weight Gain: Common due to anabolic effect of insulin.

• Sulfa Allergy: Cross-reactivity is rare but possible. Use caution in patients with severe sulfonamide allergies.

• Alcohol: Avoid. Can cause a “Disulfiram-like reaction” (flushing, nausea) and worsen hypoglycemia.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.