Export: +91 9820402906   Domestic: +91 7710003340 | HR: +91 9137757219
Glibenclamide Tablets

Glibenclamide Tablets

Available compositions:

  • Glibenclamide Tablets IP 5 mg: Glibenclamide IP 5 mg; excipients q.s.
  • Gilben — Glibenclamide Tablets BP 5 mg: Glibenclamide BP 5 mg
  • Trippleace Glibenclamide-5: Glibenclamide BP 5 mg
  • Glibenclamide & Metformin Hydrochloride SR Tablets: Glibenclamide 5 mg + Metformin Hydrochloride 500 mg; excipients q.s.

Usage: With diet and exercise to improve blood glucose control in selected adults with type 2 diabetes.

Category: Anti Diabetic Drugs

Therapeutic Category: Antidiabetic / Sulfonylurea

SKU: Glibenclamide Tablets

Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations

Product Information

Glibenclamide Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Glibenclamide Tablets 5 mg (IP / BP)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Glibenclamide (also called glyburide) is a second-generation sulfonylurea used to lower blood glucose in selected adults with type 2 diabetes, alongside diet and exercise. This page lists the supplied 5 mg IP and BP single-ingredient products and identifies the glibenclamide/metformin SR combination separately. Due to its risk of prolonged hypoglycaemia, glibenclamide is not suitable for every patient, particularly some older adults and people with kidney impairment.

2. Product Specifications

ProductComposition per tabletDosage formStandard
Glibenclamide Tablets IP 5 mgGlibenclamide IP 5 mg; excipients q.s.UncoatedIP
Gilben — Glibenclamide Tablets BP 5 mgGlibenclamide BP 5 mgUncoatedBP
Trippleace Glibenclamide-5Glibenclamide BP 5 mgUncoatedBP
Glibenclamide & Metformin Hydrochloride SR TabletsGlibenclamide 5 mg + Metformin Hydrochloride 500 mg; excipients q.s.Sustained releaseCombination

The 2.5 mg strength mentioned in the supplied description is not confirmed by a composition. The combination SR product is distinct from glibenclamide-only tablets.

3. Manufacturing Technology

Low-dose glibenclamide tablets require controlled particle size, validated blending and content uniformity. Dissolution and dosage consistency must meet the registered formulation specifications. Any claims about micronization, exact particle size, high-shear granulation or packaging formats require product-specific documentation.

4. Quality Assurance

Finished-product testing may include identification, assay, uniformity of dosage units, dissolution, related substances and stability against applicable IP/BP requirements. The release profile of the separate metformin SR combination requires modified-release testing. Specific acceptance limits and shelf life depend on the approved dossier.

5. Pharmacology and Clinical Use

Glibenclamide binds the SUR1 component of pancreatic beta-cell ATP-sensitive potassium channels, promoting insulin release and lowering blood glucose. It may be prescribed for type 2 diabetes when clinically appropriate; it is not used for type 1 diabetes or diabetic ketoacidosis. Other antidiabetic options may be preferable in people at higher risk of hypoglycaemia.

6. Export and Regulatory Support

Market-specific labeling, certificates of analysis and registration documents may be supplied subject to availability and destination-country requirements. Product-specific bioequivalence, GMP and other regulatory claims should be supported by current evidence.

7. Frequently Asked Questions

Who manufactures Glibenclamide Tablets?
Healthy Life Pharma Pvt. Ltd., India.

Is glibenclamide the same ingredient as glyburide?
Yes; glyburide is an alternative name. Brand or bioequivalence claims require product-specific confirmation.

Can it cause low blood sugar?
Yes. Hypoglycaemia may be severe or prolonged, particularly if meals are missed or with reduced kidney function.

Is the glibenclamide/metformin SR product identical?
No. It contains a second active ingredient and has different dosing and safety considerations.

8. Dosage and Administration

Dose selection and titration must be individualized by the prescriber based on blood glucose, other medicines, meal pattern, age and kidney/liver function. Follow the registered label regarding administration with meals. Do not interchange a single-ingredient 5 mg tablet with the glibenclamide 5 mg/metformin 500 mg SR combination. Do not crush sustained-release tablets unless the approved label explicitly permits it.

9. Side Effects and Precautions

  • Hypoglycaemia: Sweating, shakiness, confusion, hunger or fainting; severe symptoms require urgent medical care.
  • Other effects: Weight gain, nausea and occasional skin reactions.
  • Higher-risk groups: Older adults and people with kidney or liver impairment may be at greater risk of prolonged hypoglycaemia.
  • Interactions: Alcohol and some prescription medicines can alter blood glucose or mask warning symptoms. Review all medicines with a clinician.
  • Combination product: Metformin adds important renal-function and rare lactic-acidosis precautions.

10. Storage Instructions

Store as directed on the approved pack label, protected from excess heat and moisture. Keep in the original packaging and out of reach of children.