Description

Glimepiride Tablets (1mg / 2mg / 3mg / 4mg)

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 Glimepiride Tablets in India. Glimepiride is a Third-Generation Sulfonylurea and one of the most widely prescribed oral antidiabetics for Type 2 Diabetes Mellitus. It is distinguished by its Once-Daily Dosing, long duration of action, and a lower risk of hypoglycemia compared to older agents like Glibenclamide. It works by stimulating the pancreas to produce more insulin and improving the body’s sensitivity to insulin.

We offer Contract Manufacturing (Third Party) services for this high-volume maintenance drug. Glimepiride is potent at very low doses (starting at 1mg). Our WHO-GMP certified facility in Mumbai utilizes high-precision Automated Dosing Systems and geometric blending protocols to ensure absolute content uniformity—a critical safety factor to prevent dose-dumping or ineffective tablets. Healthy Inc manages the export logistics, supplying diabetic clinics and government health tenders across the USA, Europe, the Middle East, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Precision in every microgram.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Micronization: Glimepiride is practically insoluble in water. We use Micronized API (particle size < 5 microns) to ensure the drug dissolves immediately upon entering the stomach, providing consistent and reliable blood sugar control.

  • Color Coding: To prevent medication errors (since doses range from 1mg to 4mg), we use distinct, regulatory-approved colors for each strength (e.g., Pink for 1mg, Green for 2mg, Yellow for 3mg, Blue for 4mg).

  • Content Uniformity: Achieving a homogeneous mix for a 1mg dose in a 100mg tablet is technically challenging. We employ High-Shear Granulation to bind the active ingredient uniformly to the excipients.

• The Exporter: Healthy Inc

  • Combination Kits: We can support the packaging of “Combi-Kits” (Glimepiride + Metformin) for markets where dual therapy is the standard of care.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

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

• Related Substances: We strictly monitor for sulfonamide impurities (cis-isomer) to ensure safety.

5. Why Use Glimepiride?

Potent sugar control with insulin-sparing benefits.

• Mechanism: Glimepiride binds to specific receptors on the ATP-sensitive potassium channels of the pancreatic beta cells. This closes the channels, causing depolarization and opening calcium channels. The influx of calcium triggers the release of insulin.

• Insulin Sensitivity: Unlike older sulfonylureas, Glimepiride has a secondary extrapancreatic effect—it increases the number of active glucose transporters in muscle and fat cells, making the body’s own insulin work better.

• Key Indications:

  • Type 2 Diabetes: As monotherapy or in combination with Metformin or Insulin.

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 Glimepiride Tablets?

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

• Q: Is it Amaryl?

  A: Amaryl is the brand name (Sanofi). We manufacture the Generic Equivalent (Glimepiride), which is bioequivalent.

   

• Q: When should I take it?

  A: It must be taken once daily with breakfast (or the first main meal). Skipping the meal after taking the pill can cause low blood sugar.

• Q: Does it cause weight gain?

  A: Yes. Like all sulfonylureas, it can cause some weight gain, though generally less than older drugs like Glibenclamide.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Starting Dose: 1mg or 2mg once daily.

• Maintenance: Increase by 1mg or 2mg increments every 1-2 weeks based on blood glucose response.

• Max Dose: 8mg daily (though 4mg is the typical effective max).

• Administration: Swallow whole with liquid.

9. Side Effects and Precautions

• Hypoglycemia: Warning: Low blood sugar (tremors, sweating, confusion). Risk is higher in elderly or malnourished patients.

• Allergy: Contraindicated in patients with severe sulfonamide hypersensitivity.

• Hemolytic Anemia: Rare risk in patients with G6PD deficiency.

• Alcohol: Avoid alcohol as it can potentiate the hypoglycemic effect.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.