GENERIC NAME OF THE MEDICINAL PRODUCT:

Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/500mg (Glucotaj-ZET)
Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/400mg (Glucotaj-ZET)
Glibenclamide and Metformin Hydrochloride Tablets USP 5mg/500mg (Glucotaj-ZET)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/500mg
Each film-coated tablet contains:
Glibenclamide……………………….2.5mg
Metformin Hydrochloride………………….500mg
Excipients…………………………………………...q.s.


b) Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/400mg
Each film-coated tablet contains:
Glibenclamide………………………...2.5mg
Metformin Hydrochloride…………………...400mg
Excipients……………………………………………q.s.

c) Glibenclamide and Metformin Hydrochloride Tablets USP 5mg/500mg
Each film-coated tablet contains:
Glibenclamide………………………...5mg
Metformin Hydrochloride……………...…...500mg
Excipients …………………………………………... q.s.

THERAPEUTIC INDICATIONS:

Treatment of type 2 diabetes in adults, as replacement for previous combination therapy with metformin and glibenclamide in patients whose glycaemia is stable and well-controlled.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
ANY UNUSED PRODUCT OR WASTE MATERIAL SHOULD BE DISPOSED OF IN ACCORDANCE WITH LOCAL REQUIREMENTS.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at temperatures up to 25°C (77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg Technical Specification:

Product Name:
Glibenclamide + Metformin Hydrochloride Tablets USP
Brand Name: Glucotaj-ZET
Strength: 2.5mg/500mg, 2.5mg/400mg, 5mg/500mg
Dosage Form: Tablets
Route of Administration: Via Oral Route
Packing: 30s, 90s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Anti-diabetic, sulfonylureas.
Indication: This combination medication is used with a proper diet and exercise program to control high blood sugar in    people with type 2 diabetes.
Storage: Store at room temperature between 15 and 30 degrees C (59- and 86-degrees F). Protect from moisture and light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/500mg (Glucotaj-ZET)
  • Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/400mg (Glucotaj-ZET)
  • Glibenclamide and Metformin Hydrochloride Tablets USP 5mg/500mg (Glucotaj-ZET)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/500mg
Each film-coated tablet contains:
Glibenclamide……………………….2.5mg
Metformin Hydrochloride………………….500mg
Excipients……………………………………………q.s.

b) Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/400mg
Each film-coated tablet contains:
Glibenclamide…………………………2.5mg
Metformin Hydrochloride……………………400mg
Excipients……………………………………………q.s.

c) Glibenclamide and Metformin Hydrochloride Tablets USP 5mg/500mg
Each film-coated tablet contains:
Glibenclamide…………………………5mg
Metformin Hydrochloride……………………500mg
Excipients …………………………………………… q.s.

THERAPEUTIC INDICATIONS:

  • Treatment of type 2 diabetes in adults, as replacement for previous combination therapy with metformin and glibenclamide in patients whose glycaemia is stable and well-controlled.

CAUTION & WARNING:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    Any unused product or waste material should be disposed of in accordance with local requirements.
  • Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

  • Storage: Keep the bottle tightly closed in order to protect from moisture. must be stored in a cool, dry place, away from sunlight and moisture.
  • Dosage:As directed by the Physician.

Introduction to Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg

Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg are widely prescribed combination anti-diabetic medicines used for the treatment of type 2 diabetes mellitus in adults. This fixed-dose combination is recommended when diet, exercise, and single-drug therapy are insufficient to control blood glucose levels effectively.

Glibenclamide works by stimulating insulin release from the pancreas, while Metformin Hydrochloride reduces glucose production in the liver and improves insulin sensitivity. Together, they provide synergistic blood sugar control, making this combination highly effective and popular in diabetes management protocols worldwide.

Due to the rapid global rise in type 2 diabetes, especially in developing and emerging economies, the demand for high-quality, affordable combination therapies such as Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg is consistently increasing.

Taj Pharma, a well-known Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg Manufacturer in India, ensures international-quality standards, high purity, and reliable supply for domestic and global markets.


Therapeutic Uses and Clinical Importance

What is Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg Used For?

  • Treatment of type 2 diabetes mellitus in adults

  • Control of fasting and postprandial blood glucose levels

  • Prevention of diabetes-related complications such as kidney damage, nerve problems, vision loss, and cardiovascular diseases

Why This Combination is Clinically Effective

  • Dual mechanism of action

  • Improved glycemic control compared to monotherapy

  • Reduces insulin resistance

  • Widely recommended by healthcare professionals


Trusted Manufacturer, Exporter & Supplier

Taj Pharma Ltd, headquartered in Vapi, Gujarat, India, is a well-established Manufacturer, Exporter, and Supplier of Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg.

As a reputed WHO-GMP certified pharmaceutical company, Taj Pharma assures:

  • High-quality raw materials

  • Strict quality control at every stage

  • International regulatory compliance

  • Consistent batch-to-batch quality

Taj Pharma is recognized as a Leading #1 Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg Manufacturer & Supplier in India, trusted by global buyers, distributors, and healthcare institutions.


Dosage, Administration & Patient Guidance

  • Administration: Should be taken with food to reduce gastrointestinal side effects

  • Dosage: As prescribed by a healthcare professional; dosage may vary based on blood sugar levels

  • Consistency: Take regularly at the same time each day for optimal benefit

Important Patient Advice

  • Continue medication even if blood sugar is controlled

  • Do not stop without consulting your doctor

  • Follow a healthy diet, regular exercise, and weight management plan

  • Monitor blood glucose levels regularly

Lifestyle modification plays a critical role in diabetes management alongside medication.


Side Effects, Warnings & Precautions

Common Side Effects

  • Nausea

  • Vomiting

  • Diarrhea

  • Abdominal pain

  • Headache

  • Weight gain in some patients

Risk of Hypoglycemia

Symptoms may include:

  • Sweating

  • Dizziness

  • Shaking

  • Headache

Preventive Measures:

  • Eat regular meals

  • Carry a fast-acting glucose source

  • Avoid alcohol consumption

Who Should Avoid This Medicine?

  • Patients with type 1 diabetes mellitus

  • Diabetic ketoacidosis

  • Severe kidney or liver disease

  • Known hypersensitivity to components

Pregnant or breastfeeding women should consult a doctor before use.


In-Depth Details for Importers, Exporters & Buyers

Regulatory Documentation Provided

Taj Pharma provides comprehensive regulatory support, including:

  • WHO-GMP certification

  • EU-GMP (on request)

  • Certificate of Pharmaceutical Product (COPP)

  • CTD / eCTD Dossiers

  • Certificate of Analysis (CoA)

  • Stability data

Custom Packaging & Labeling

  • Blister packs and HDPE bottles

  • Alu-Alu and PVC blister options

  • Multilingual labeling as per country regulations

  • Private labeling and PCD Pharma Franchise opportunities

Shelf Life, Storage & Dosage Form

  • Dosage Form: Tablets

  • Strength: 2.5mg Glibenclamide + 400mg Metformin Hydrochloride

  • Shelf Life: 24–36 months

  • Storage: Store below 25°C, protect from moisture and light

Target Countries & Export Markets

  • Africa

  • Middle East

  • Southeast Asia

  • Latin America

  • CIS Countries


Why Taj Pharma is the Most Trusted Manufacturer & Exporter

State-of-the-Art Manufacturing

  • Modern WHO-GMP compliant manufacturing units

  • Automated production and packaging lines

  • In-house quality control laboratories

Affordable Pricing & Quality Assurance

  • Competitive bulk pricing

  • High-quality assurance with global standards

  • Cost-effective solutions for emerging markets

Global Presence & Supply Chain Support

  • Strong export network

  • Reliable logistics and timely deliveries

  • Regulatory assistance for smooth import processes

Top 20 Export Countries

Nigeria | Kenya | Ghana | Tanzania | Uganda | Myanmar | Vietnam | Philippines | Yemen | Afghanistan | Iraq | Iran | Peru | Bolivia | Chile | Mexico | Dominican Republic | Nepal | Cambodia |Ethiopia


Technical Product Specification Table

Parameter Specification
Product Name Glibenclamide and Metformin Hydrochloride Tablets
Strength 2.5mg / 400mg
Dosage Form Tablet
Therapeutic Class Anti-diabetic
Route of Administration Oral
Shelf Life 24–36 Months
Storage Below 25°C
Packaging Blister / HDPE Bottle
Certification WHO-GMP
Manufacturer Taj Pharma Ltd, India

PAN India Manufacturer & PCD Pharma Franchise

Taj Pharma offers:

  • PAN India manufacturing and supply

  • PCD Pharma Franchise / Manufacturer and Supplier

  • Monopoly rights in select territories

  • Marketing and promotional support


Call to Action

If you are looking for a reliable Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg Manufacturer in India, Taj Pharma is your ideal partner.

✔ WHO-GMP certified manufacturing
✔ Competitive pricing
✔ Global export expertise
✔ Custom packaging & regulatory support

📩 Contact Taj Pharma today to source high-quality anti-diabetic tablets and grow your pharmaceutical business globally.


Top 20 FAQs 

  1. What is this tablet used for?
    Type 2 diabetes mellitus.

  2. Who manufactures it in India?
    Taj Pharma.

  3. Is it WHO-GMP certified?
    Yes.

  4. How should it be taken?
    With food, as prescribed.

  5. Can it cause low blood sugar?
    Yes, especially if meals are skipped.

  6. Is alcohol safe with this medicine?
    No, it should be avoided.

  7. Shelf life?
    24–36 months.

  8. Packaging options?
    Blister and HDPE bottles.

  9. Is private labeling available?
    Yes.

  10. Export documentation provided?
    Yes.

  11. Can pregnant women take it?
    Only after medical advice.

  12. Is it suitable for type 1 diabetes?
    No.

  13. PCD Pharma Franchise available?
    Yes.

  14. Manufacturing location?
    Vapi, Gujarat, India.

  15. Bulk supply possible?
    Yes.

  16. Is EU-GMP available?
    On request.

  17. Does it help prevent complications?
    Yes, by controlling blood sugar.

  18. Storage conditions?
    Store below 25°C.

  19. Target export markets?
    Africa, Asia, Middle East, LATAM.

  20. How to contact Taj Pharma?
    Through official sales channels.