Description

Glimepiride and Metformin HCl SR Tablets (1mg/500mg / 2mg/500mg / 1mg/1000mg)

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 and Metformin HCl SR Tablets in India. This Fixed-Dose Combination (FDC) is a modern, potent anti-diabetic formulation used for the management of Type 2 Diabetes Mellitus. It combines Glimepiride (a third-generation Sulfonylurea) with Metformin Sustained Release (SR) (a Biguanide) to provide dual-action glucose control with a lower risk of hypoglycemia compared to older sulfonylureas.

We offer Contract Manufacturing (Third Party) for this high-demand bilayer or matrix formulation. Our WHO-GMP certified facility in Mumbai utilizes sophisticated polymer blending technology to ensure the Metformin component releases slowly over an extended period, improving gastric tolerance. Healthy Inc manages the export logistics, supplying diabetes care programs, pharmacies, and distributors across Southeast Asia, Latin America, and Africa.

2. Product Specifications

3. Manufacturing Glimepiride + Metformin SR

Combining a low-dose potent drug with a high-dose bulk drug requires precision.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  We typically use Bilayer Tablet Technology. One layer contains Glimepiride for immediate release to manage post-meal spikes, while the other layer contains Metformin in a Hydrophilic Matrix (SR). This ensures 24-hour glycemic control. We use advanced blending to ensure the micro-dose of Glimepiride (1-2mg) is perfectly distributed, preventing dose variation.

• The Exporter: Healthy Inc

  Healthy Inc ensures that the product maintains its stability during global shipping. We use high-grade Moisture Barrier Packaging (PVDC or Alu-Alu) because Metformin is hygroscopic. We handle all regulatory filings, ensuring the product meets the specific dissolution profiles (drug release rates) required by international health ministries.

4. Quality Assurance

We adhere to strict testing protocols for Modified Release tablets:

• Dissolution Profiling: We test the Metformin release at multiple time points (1h, 4h, 8h, 12h) to confirm the sustained release mechanism prevents “dose dumping.”

• Uniformity of Dosage Units: We ensure strict content uniformity for Glimepiride to avoid hypoglycemia risks.

• Impurity Profiling: We strictly monitor for related substances, including potential sulfonylurea degradation products.

5. Why Use Glimepiride + Metformin SR?

It is a preferred combination for uncontrolled Type 2 Diabetes.

• Mechanism:

  • Glimepiride: Stimulates the pancreas to release insulin in a glucose-dependent manner (works better when sugar is high).

  • Metformin: Decreases glucose production in the liver and improves insulin sensitivity in muscles.

• Advantages: Glimepiride has a faster onset and longer duration than Glibenclamide, with a lower risk of causing severe low blood sugar. The SR form of Metformin reduces stomach upset.

• Key Indications:

  • Type 2 Diabetes: For patients not controlled on Metformin alone or diet/exercise alone.

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 Metformin SR Tablets?

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

• Q: When should I take this tablet?

  A: Usually once daily with breakfast or the first main meal of the day.

• Q: Is Glimepiride safer than Glibenclamide?

  A: Generally, yes. It is considered “pancreas-sparing” and has a lower risk of hypoglycemia.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: One tablet daily.

• Titration: Dosage should be started at the lowest effective dose and increased gradually based on blood glucose monitoring.

• Administration: Swallow whole with water; do not chew or crush the SR tablet.

9. Side Effects and Precautions

• Common Side Effects: Hypoglycemia (tremors, sweating), nausea, taste disturbance, and weight gain (mild).

• Lactic Acidosis: Rare but serious risk associated with Metformin (avoid in severe kidney failure).

• Interactions: Caution with other protein-bound drugs, alcohol, and certain antibiotics.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture and light.