Glibenclamide and Metformin Hydrochloride Tablets 5mg/500mg

Glibenclamide and Metformin Hydrochloride Tablets  5mg/500mg Technical Specification:

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 5mg/500mg

Glibenclamide and Metformin Hydrochloride Tablets 5mg/500mg are widely prescribed combination antidiabetic medicines used in the treatment of type 2 diabetes mellitus in adults. This fixed-dose combination brings together two complementary mechanisms of action to effectively control high blood sugar levels when diet and exercise alone are not sufficient.

Glibenclamide stimulates the pancreas to release more insulin, while Metformin improves insulin sensitivity and reduces glucose production in the liver. Together, they provide better glycemic control, reduce long-term complications of diabetes, and improve overall metabolic outcomes.

With the global rise in diabetes prevalence—especially in Asia, Africa, the Middle East, and Latin America—the demand for affordable, high-quality combination antidiabetic tablets is growing rapidly. This has positioned India as a key manufacturing hub, and Taj Pharma stands out as a reliable Glibenclamide and Metformin Hydrochloride Tablets 5mg/500mg Manufacturer, Supplier, and Exporter in India.

 Trusted Manufacturer, Exporter & Supplier

Taj Pharma Ltd, based in Vapi, Gujarat, India, is a well-established pharmaceutical company known for its WHO-GMP certified manufacturing facilities, stringent quality control systems, and strong export orientation.

As a leading Glibenclamide and Metformin Hydrochloride Tablets 5mg/500mg Manufacturer in India, Taj Pharma provides:

• Consistent batch-to-batch quality

• High purity active pharmaceutical ingredients (APIs)

• Scalable bulk production for domestic and export markets

• Private labeling and PCD Pharma Franchise support

Global buyers trust Taj Pharma for regulatory compliance, reliability, and long-term partnerships.

Therapeutic Uses & Benefits

Primary Indication

• Treatment of Type 2 Diabetes Mellitus in adults

Key Benefits

• Dual-action glucose control through insulin release and improved insulin sensitivity

• Helps reduce fasting and postprandial blood sugar levels

• Lowers the risk of diabetes-related complications such as kidney damage, nerve damage, vision loss, and cardiovascular disease

• Convenient once or twice daily dosing (as prescribed)

This combination is especially useful in patients whose blood sugar levels are not adequately controlled with single-drug therapy.

Dosage & Administration Guidelines

• Should be taken with food to reduce gastrointestinal side effects

• Taken at the same time each day for maximum benefit

• Dosage is individualized and adjusted by the physician based on blood glucose levels

• Do not discontinue without consulting a healthcare provider

Lifestyle measures such as healthy diet, regular exercise, and weight management play a vital role alongside medication.

Safety Profile & Side Effects

Common Side Effects

• Nausea

• Vomiting

• Diarrhea

• Abdominal pain

• Headache

Risk of Hypoglycemia

Low blood sugar may occur, especially if meals are skipped, alcohol is consumed, or the medicine is combined with other antidiabetic drugs. Symptoms include sweating, dizziness, shaking, headache, and confusion.

Precautions

• Avoid alcohol consumption

• Carry a fast-acting glucose source

• Not suitable for type 1 diabetes or diabetic ketoacidosis

• Use with caution in patients with kidney, liver, or heart disease

• Pregnant and breastfeeding women should consult a doctor

Regular monitoring of blood sugar, liver function, and kidney function is advised.

In-Depth Details for Importers, Exporters & Buyers

Regulatory Documentation Provided

Taj Pharma supports seamless global trade with complete documentation, including:

• WHO-GMP Certificate

• Certificate of Analysis (COA)

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate

• Stability Data

• CTD / ACTD Dossiers (on request)

Custom Packaging & Labeling

• Alu-Alu and PVC-Alu blister packs

• HDPE bottles with tamper-evident caps

• Multilingual labels compliant with importing country regulations

• Private labeling for brands, hospitals, and franchise partners

Shelf Life, Storage & Dosage Form

• Dosage Form: Tablet

• Strength: Glibenclamide 5mg + Metformin Hydrochloride 500mg

• Shelf Life: 24–36 months

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

Export Certifications

• WHO-GMP

• ISO 9001:2015

• COPP

• CTD/ACTD Dossiers for regulated markets

Target Countries & Export Markets

Taj Pharma exports to over 20 countries, including:

• UAE

• Saudi Arabia

• Nigeria

• Kenya

• Ghana

• South Africa

• Bangladesh

• Sri Lanka

• Philippines

• Vietnam

• Myanmar

• Egypt

• Iraq

• Yemen

• Kazakhstan

• Uzbekistan

• Peru

• Colombia

• Bolivia

• Venezuela

Why Taj Pharma is the Most Trusted Manufacturer & Exporter

State-of-the-Art Manufacturing

Taj Pharma’s advanced manufacturing units in Vapi follow validated processes, automated equipment, and strict in-process quality checks, ensuring international-grade products.

Affordable Pricing & Quality Assurance

India’s cost efficiency combined with Taj Pharma’s optimized production allows competitive pricing without compromising quality, ideal for both regulated and semi-regulated markets.

Global Presence & Supply Chain Support

• Reliable logistics partners

• On-time dispatch

• Export-oriented documentation team

• Dedicated customer support for global buyers

Top 20 Exporting Countries

Nigeria || Kenya || Ghana || Uganda || South Africa || UAE || Saudi Arabia || Oman || Qatar|| Kuwait || Russia || Kazakhstan || Uzbekistan || Kyrgyzstan || Vietnam || Philippines || Myanmar || Sri Lanka || Peru || Chile ||

Technical Product Specification Table

Call to Action  

If you are looking for a reliable Glibenclamide and Metformin Hydrochloride Tablets 5mg/500mg Manufacturer & Supplier in India, Taj Pharma is your ideal partner.

📩 Contact Taj Pharma today for:

• Bulk supply

• Export partnerships

• Private labeling

• PCD Pharma Franchise opportunities

Grow your pharmaceutical business with a trusted Indian manufacturer.

Top 20 FAQs 

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

2. Is Taj Pharma WHO-GMP certified?
   Yes.

3. Can it cause hypoglycemia?
   Yes, especially if meals are skipped.

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

5. Is private labeling available?
   Yes.

6. Shelf life of the tablets?
   24–36 months.

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

8. Can it be exported globally?
   Yes.

9. Does it cause weight gain?
   Some patients may experience weight gain.

10. Storage conditions?
    Below 25°C, dry place.

11. Can alcohol be consumed?
    Not recommended.

12. Is PCD franchise available?
    Yes.

13. Is it safe in kidney disease?
    Only under medical supervision.

14. Export documentation provided?
    Yes, complete support.

15. Is it suitable for elderly patients?
    With dose adjustment and monitoring.

16. Can it be combined with insulin?
    Only if prescribed by a doctor.

17. Packaging options available?
    Blister and bottle packs.

18. Manufacturing location?
    Vapi, Gujarat, India.

19. Does Taj Pharma export to Africa?
    Yes.

20. Why choose Taj Pharma?
    Quality, compliance, affordability, and trust.