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

Glibenclamide and Metformin Hcl Tablets  2.5mg/500mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• a) Glibenclamide and Metformin Hydrochloride Tablets IP 2.5mg/500mg
  Each film-coated tablet contains:
  Glibenclamide IP……………………….2.5mg
  Metformin Hydrochloride IP………………….500mg
  Excipients……………………………………………q.s. 
  Colours: Iron oxide Red
• b) Glibenclamide and Metformin Hydrochloride Tablets IP 2.5mg/400mg
  Each film-coated tablet contains:
  Glibenclamide IP…………………………2.5mg
  Metformin Hydrochloride IP……………………400mg
  Excipients……………………………………………q.s.
  Colours: Iron oxide Yellow
• c) Glibenclamide and Metformin Hydrochloride Tablets IP 5mg/500mg
  Each film-coated tablet contains:
  Glibenclamide IP…………………………5mg
  Metformin Hydrochloride IP……………………500mg
  Excipients …………………………………………… q.s.
  Colours: Quinoline Yellow

 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.
• SCHEDULE “H” Prescription Drug –Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

• Storage:Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
• Dosage:As directed by the Physician.

Introduction to Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/500mg (Glucotaj-ZET)

Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/500mg (Glucotaj-ZET) are a fixed-dose combination therapy designed to treat Type 2 Diabetes Mellitus (T2DM) effectively. Diabetes is one of the most pressing health challenges worldwide, and combination medicines like Glucotaj-ZET play a crucial role in keeping blood sugar levels under control.

• Glibenclamide belongs to the sulfonylurea class, which stimulates the pancreas to release more insulin, thereby lowering blood glucose levels.

• Metformin, from the biguanide class, reduces glucose production in the liver, delays glucose absorption in the intestines, and enhances the body’s insulin sensitivity.

This dual mechanism of action makes the formulation highly effective in improving glycemic control, especially in adults who do not respond adequately to diet and exercise alone.

With the growing global prevalence of Type 2 diabetes, the demand for affordable and WHO-GMP quality Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/500mg (Glucotaj-ZET) continues to rise across Asia, Africa, Middle East, and Latin America.

In-depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided

Taj Pharma ensures seamless international trade by providing comprehensive documentation required for product registration and import:

• Certificate of Pharmaceutical Product (COPP) under WHO format

• Drug Master File (DMF) / CTD Dossier

• Certificate of Analysis (COA) for every batch

• WHO-GMP and EU-GMP certifications

• Free Sale Certificate

• Batch Manufacturing Records (BMR)

This helps importers gain swift regulatory approvals in both regulated and semi-regulated markets.

Custom Packaging & Labeling

Taj Pharma offers customized packaging solutions to suit market-specific requirements:

• Blister, alu-alu, or HDPE bottles

• Private labeling with buyer’s branding

• Multilingual packaging (Arabic, French, Spanish, etc.)

• Export-compliant tamper-proof packaging

Shelf-Life, Storage & Dosage Form

• Dosage Form: Oral film-coated tablets

• Strength: Glibenclamide 2.5mg + Metformin 500mg

• Shelf Life: 24–36 months

• Storage Conditions: Store in a cool, dry place below 25°C, protected from moisture and sunlight

Export Certifications – Quality You Can Trust

Taj Pharma’s state-of-the-art facilities in Vapi, Gujarat are internationally accredited. The company holds:

• WHO-GMP certification

• EU-GMP approval

• ISO 9001:2015 certification

• COPP for global market registrations

• PIC/S compliance

Target Countries & Export Markets

Taj Pharma’s Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/500mg (Glucotaj-ZET) are exported to over 40 countries across:

• Africa: Nigeria, Ghana, Kenya, Ethiopia, South Africa

• Asia: Vietnam, Philippines, Sri Lanka, Bangladesh, Cambodia

• Middle East: UAE, Saudi Arabia, Oman, Iraq, Yemen

• Latin America: Peru, Bolivia, Ecuador, Dominican Republic

• CIS Countries: Uzbekistan, Kazakhstan, Ukraine, Georgia

Why is the Most Trusted Manufacturer, Supplier, and Exporter

State-of-the-Art Manufacturing Facilities

• WHO-GMP, EU-GMP, and USFDA compliant production units

• Advanced R&D labs with automated equipment

• Strict quality assurance (QA) and quality control (QC) protocols

Affordable Pricing with Assured Quality

• Cost-effective formulations for international tenders and NGOs

• Competitive bulk supply pricing without compromising quality

• Tested for safety, purity, and therapeutic efficacy

Global Presence & Supply Chain Support

• End-to-end logistics support

• On-time delivery with compliant export documentation

• Partnership with global distributors, hospitals, and government health programs

Top 20 Export Destinations of Taj Pharma’s Glucotaj-ZET

Nigeria, Kenya, South Africa, Vietnam, Philippines, Iraq, Libya, Uzbekistan, Ghana, Ethiopia, Yemen, Tanzania, Sri Lanka, Afghanistan, Myanmar, Nepal, Kazakhstan, Ecuador, Bangladesh, Dominican Republic

Technical Product Specification Table

Are you looking for a reliable Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/500mg (Glucotaj-ZET) manufacturer in India?

👉 Partner with Taj Pharma Ltd – a trusted WHO-GMP certified exporter known for quality, affordability, and compliance.

📩 Contact Taj Pharma today for:

• Bulk supply orders

• Tender participation

• PCD Pharma Franchise opportunities

• International distribution partnerships

Top 20 FAQs 

Q1. What is Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/500mg used for?
A: It is prescribed for Type 2 Diabetes Mellitus to improve blood sugar control.

Q2. Who is the top manufacturer in India?
A: Taj Pharma Ltd, Vapi, Gujarat.

Q3. Can this medicine be exported globally?
A: Yes, Taj Pharma exports to over 40 countries.

Q4. What certifications does Taj Pharma hold?
A: WHO-GMP, EU-GMP, ISO 9001:2015, COPP.

Q5. Can I get custom branding and packaging?
A: Yes, Taj Pharma offers private labeling and multilingual packaging.

Q6. What is the shelf-life?
A: 24–36 months.

Q7. What are the common side effects?
A: Nausea, diarrhea, dizziness, flatulence, and rarely lactic acidosis.

Q8. How should the medicine be taken?
A: Always take it with food to reduce stomach upset.

Q9. Can it cause hypoglycemia?
A: Yes, especially if combined with other antidiabetics or missed meals.

Q10. What makes Taj Pharma the best exporter?
A: Quality, affordability, global presence, and regulatory compliance.

Q11. Is it available PAN India?
A: Yes, with PCD Pharma Franchise opportunities.

Q12. Does Taj Pharma provide COA and DMF?
A: Yes, all regulatory documents are available.

Q13. What markets are targeted?
A: Africa, Asia, Middle East, CIS, and Latin America.

Q14. How affordable is it compared to other brands?
A: Taj Pharma provides cost-effective formulations for bulk buyers.

Q15. Can it be combined with insulin?
A: Only under medical supervision.

Q16. What packaging options are available?
A: Blister packs, alu-alu, or bottles.

Q17. Does Taj Pharma supply to hospitals?
A: Yes, including government tenders and institutional supply.

Q18. Is it safe for long-term use?
A: Yes, under physician guidance with monitoring.

Q19. Can Taj Pharma help with registrations?
A: Yes, Taj Pharma provides CTD dossiers and COPP.

Q20. How can I place an order?
A: Through Taj Pharma’s international business team via official website or direct contact.

For international buyers seeking a trusted Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/500mg (Glucotaj-ZET) manufacturer in India, Taj Pharma is the ideal partner. With WHO-GMP facilities, global regulatory approvals, cost-effective pricing, and strong export expertise, Taj Pharma ensures quality diabetes care solutions for global markets.