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

Glibenclamide and Metformin HCL Tablets 2.5mg/400mg 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/400mg (Glucotaj-ZET)

Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg (Glucotaj-ZET) are a fixed-dose combination therapy widely prescribed for the management of Type 2 Diabetes Mellitus (T2DM). This combination is highly effective because it brings together two complementary mechanisms of action:

• Glibenclamide (Sulfonylurea Class): Stimulates the pancreas to release insulin, thus reducing elevated blood glucose.

• Metformin (Biguanide Class): Reduces glucose production by the liver and delays its absorption in the intestines, improving insulin sensitivity.

The medicine is primarily prescribed when diet and lifestyle modifications alone are insufficient to control blood glucose. Due to its proven efficacy, it enjoys high global demand among doctors, hospitals, and healthcare systems for controlling chronic diabetes.

With Type 2 Diabetes being one of the fastest-growing health concerns worldwide, the demand for affordable, WHO-GMP quality Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg (Glucotaj-ZET) continues to rise, especially in Asia, Africa, Middle East, and Latin America.

In-depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided by Taj Pharma

Taj Pharma ensures complete regulatory support for international buyers. The company provides:

• Certificate of Pharmaceutical Product (COPP) under WHO format.

• Drug Master File (DMF) / CTD Dossier.

• Certificate of Analysis (COA).

• Batch Manufacturing Record (BMR).

• Free Sale Certificate.

• WHO-GMP / EU-GMP Certificates.

This guarantees smooth product registration in both regulated and semi-regulated markets.

Custom Packaging & Labeling

Taj Pharma understands the importance of market adaptability and offers:

• Blister packs, alu-alu packs, or bottles.

• Custom branding with buyer’s logo.

• Multilingual labeling as per country-specific regulations.

• Tamper-proof and export-compliant packaging.

Shelf-Life, Storage & Dosage Form

• Dosage Form: Oral tablet (film-coated).

• Shelf Life: 24–36 months depending on packaging.

• Storage Conditions: Store below 25°C, in a dry place, away from sunlight.

• Dosage Strength: Glibenclamide 2.5mg + Metformin Hydrochloride 400mg.

Export Certifications – Global Quality Standards

Taj Pharma is committed to international compliance with certifications including:

• WHO-GMP (World Health Organization – Good Manufacturing Practice).

• EU-GMP (European Union compliance).

• ISO 9001:2015 certification.

• COPP for international registrations.

• PIC/S compliance.

Target Countries & Export Markets

Taj Pharma supplies Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg (Glucotaj-ZET) to over 40 countries worldwide, including:

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

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

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

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

• CIS & Eastern Europe: Ukraine, Uzbekistan, Kazakhstan, Georgia.

Why Taj Pharma is the Most Trusted Manufacturer, Supplier & Exporter

Taj Pharma stands as a top manufacturer of Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg (Glucotaj-ZET) in India due to its dedication to quality, affordability, and reliability.

State-of-the-Art Manufacturing

• Located in Vapi, Gujarat, with USFDA, WHO-GMP, and EU-GMP compliant plants.

• Fully automated production lines with minimal human interference.

• Stringent quality assurance (QA) and quality control (QC) systems.

Affordable Pricing & Quality Assurance

• Competitive pricing for bulk buyers, distributors, and tenders.

• Cost-effective formulations without compromising international quality standards.

• Multi-layered testing for purity, safety, and efficacy.

Global Presence & Supply Chain Support

• Robust global distribution network.

• On-time delivery with cold-chain management when required.

• End-to-end logistics support for importers, tenders, NGOs, and hospitals.

Top 20 Countries Exporting from Taj Pharma

Nigeria, Kenya, Ghana, Iraq, UAE, Saudi Arabia, Bangladesh, Sri Lanka, Vietnam, Ukraine, Uzbekistan, Colombia, Peru, Ecuador, Philippines, Tanzania, Myanmar, Cambodia, Jordan, Zambia

Technical Product Specification Table

If you are looking for a reliable, WHO-GMP certified manufacturer of Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg (Glucotaj-ZET), Taj Pharma is your trusted partner.

👉 Contact Taj Pharma today for bulk supply, PCD Pharma Franchise, international distribution, or tender requirements. With global reach, affordable prices, and regulatory compliance, Taj Pharma ensures seamless cooperation for importers and distributors worldwide.

Top 20 FAQs 

Q1: What is Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg used for?
A: It is prescribed to manage Type 2 Diabetes Mellitus by reducing blood sugar levels.

Q2: Who manufactures Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg in India?
A: Taj Pharma Ltd, Vapi, Gujarat, is a leading WHO-GMP manufacturer.

Q3: Can this medicine be exported to Africa and the Middle East?
A: Yes, Taj Pharma actively exports to Nigeria, Kenya, UAE, Oman, and Saudi Arabia.

Q4: What certifications does Taj Pharma hold?
A: WHO-GMP, EU-GMP, ISO, COPP, and CTD dossiers for global registrations.

Q5: Is Glucotaj-ZET available for PCD Pharma Franchise?
A: Yes, Taj Pharma offers PCD Franchise opportunities PAN India.

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

Q7: What are the side effects of Glibenclamide + Metformin?
A: Common side effects include nausea, diarrhea, headache, dizziness, and rare lactic acidosis.

Q8: How should the medicine be taken?
A: It should be taken with food to reduce gastrointestinal upset.

Q9: Can it be used with insulin?
A: Only under medical supervision.

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

Q11: Can custom packaging be provided?
A: Yes, Taj Pharma offers private labeling and customized export packs.

Q12: What markets does Taj Pharma target?
A: Africa, Asia, CIS, Latin America, and the Middle East.

Q13: Does Taj Pharma provide COA and DMF?
A: Yes, complete regulatory documentation is provided.

Q14: How affordable is Glucotaj-ZET compared to brands?
A: Taj Pharma offers competitive bulk export pricing.

Q15: What storage conditions are required?
A: Below 25°C, dry, and away from sunlight.

Q16: Can Glucotaj-ZET cause hypoglycemia?
A: Yes, hypoglycemia may occur, especially if diet control is poor.

Q17: Is the product WHO prequalified?
A: Taj Pharma provides WHO-GMP compliant production.

Q18: Is it available in 500mg Metformin strength?
A: Yes, Taj Pharma manufactures multiple strengths as per demand.

Q19: Is Glucotaj-ZET suitable for elderly patients?
A: With caution, under physician’s guidance.

Q20: How can distributors contact Taj Pharma?
A: Via official website, email, or direct international business desk.

When it comes to sourcing Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg (Glucotaj-ZET) manufacturer in India, Taj Pharma stands as the most reliable partner for global buyers. With WHO-GMP quality, regulatory compliance, global reach, and cost-effective pricing, Taj Pharma ensures international clients receive trusted diabetes solutions for their markets.