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

Glibenclamide and Metformin Hcl Tablets 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 HCl Tablets 5mg/500mg

Glibenclamide and Metformin HCl Tablets 5mg/500mg are widely prescribed for the management of Type 2 diabetes mellitus. This fixed-dose combination offers dual benefits:

• Glibenclamide (5mg): A sulfonylurea that works by stimulating the pancreas to release more insulin.

• Metformin HCl (500mg): A biguanide that decreases glucose production in the liver, slows absorption from the intestines, and improves insulin sensitivity.

Together, this combination helps patients maintain better blood sugar control, reduces the risk of complications like kidney damage, cardiovascular disease, and nerve issues, and is often prescribed when lifestyle modifications and monotherapy are insufficient.

The demand for Glibenclamide and Metformin HCl Tablets 5mg/500mg manufacturers in India is growing globally due to the rising prevalence of diabetes, affordability of Indian generics, and compliance with WHO-GMP and EU-GMP standards.

In-depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided by Taj Pharma

Taj Pharma ensures complete transparency and regulatory compliance, offering global buyers a wide range of documents including:

• Certificate of Pharmaceutical Product (WHO-COPP)

• Certificate of Analysis (CoA)

• Stability Studies (Long-term and Accelerated)

• Dossier in CTD/ACTD format

• EU-GMP / WHO-GMP certifications

• Free Sale Certificate (FSC)

• Manufacturing License & Batch Records

These documents help buyers and importers obtain drug approvals in their local markets seamlessly.

Custom Packaging & Labeling

• Available in blister packs / strip packs / bottles

• Multilingual packaging available as per importer requirements

• Custom branding for PCD franchise partners

• Tamper-proof and moisture-protected packaging

Shelf-life, Storage, and Dosage Form

• Shelf-life: 24–36 months

• Dosage form: Film-coated tablets

• Storage: Store below 25°C, in a dry place, away from light and moisture

Export Certifications

Taj Pharma is a globally recognized exporter with certifications like:

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

• EU-GMP (European Union Good Manufacturing Practice)

• ISO 9001:2015 Certified

• COPP (Certificate of Pharmaceutical Product)

• CTD Dossier Submission Support

• FDA-compliant facilities

Target Countries & Export Markets

Taj Pharma’s Glibenclamide and Metformin HCl Tablets 5mg/500mg are widely exported across:

• Latin America (Brazil, Chile, Peru)

• Africa (Nigeria, Kenya, South Africa, Ethiopia)

• Asia (Vietnam, Philippines, Thailand, Sri Lanka, Bangladesh)

• Middle East (Saudi Arabia, UAE, Iraq, Yemen)

• CIS countries (Russia, Ukraine, Kazakhstan)

• Europe (Poland, Romania, Bulgaria)

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

1. State-of-the-Art Manufacturing Facilities

• Located in Vapi, Gujarat & Mumbai, Maharashtra

• Equipped with WHO-GMP, EU-GMP, and FDA-compliant plants

• Dedicated production lines for oral solid dosage forms

• Automated systems for quality, safety, and batch consistency

2. Affordable Pricing & Quality Assurance

• Cost-effective manufacturing ensures competitive export pricing

• Stringent QA/QC protocols at every stage

• Compliance with ICH guidelines and international pharmacopoeias (USP, BP, IP)

• Affordable prices without compromising therapeutic efficacy

3. Global Presence & Supply Chain Support

• Strong distribution network in over 40+ countries

• Strategic logistics partnerships ensuring on-time delivery

• Support for tender supplies, government contracts, NGOs, and private distributors

4. Top 20 Countries Exporting Glibenclamide and Metformin HCl Tablets 5mg/500mg

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 trusted Glibenclamide and Metformin HCl Tablets 5mg/500mg manufacturer in India? Taj Pharma is your ideal partner for high-quality, affordable, and globally certified diabetes medications.

👉 Contact Taj Pharma today to discuss bulk supply, export partnerships, or PCD franchise opportunities.

📩 Email: export@tajpharma.com
🌐 Website: www.tajpharma.com

Top 20 FAQs

1. What is Glibenclamide and Metformin HCl used for?
It is prescribed to manage Type 2 diabetes by controlling blood sugar levels.

2. How does Glibenclamide work?
It stimulates the pancreas to release more insulin.

3. How does Metformin work?
It reduces glucose production in the liver, delays absorption, and improves insulin sensitivity.

4. Can this medicine cure diabetes?
No, it controls diabetes but does not cure it.

5. Who should not take it?
People with kidney/liver impairment or lactic acidosis risk should avoid it.

6. Can it be taken on an empty stomach?
No, it is recommended to take with food.

7. What are common side effects?
Nausea, diarrhea, dizziness, and headache.

8. Can it cause low blood sugar (hypoglycemia)?
Yes, Glibenclamide can cause low sugar episodes.

9. Is it safe in pregnancy?
Not recommended unless prescribed by a doctor.

10. Is it available for export from India?
Yes, Taj Pharma exports globally with WHO-GMP certification.

11. What is the shelf life?
24–36 months.

12. What is lactic acidosis?
A rare but serious buildup of lactic acid in the blood caused by Metformin.

13. Can alcohol be consumed with this medicine?
No, alcohol increases the risk of side effects.

14. Is it safe for children?
Not recommended for children under 18.

15. Can it be used with insulin?
Yes, under strict medical supervision.

16. Does Taj Pharma provide custom branding?
Yes, for PCD pharma franchise & private label exports.

17. Does Taj Pharma provide dossiers for registration?
Yes, complete CTD/ACTD dossiers are available.

18. Is it available in bulk for tenders?
Yes, Taj Pharma supplies to government & NGO tenders worldwide.

19. Does Taj Pharma offer third-party manufacturing?
Yes, Taj Pharma supports contract manufacturing for global clients.

20. Why choose Taj Pharma for diabetes medicines?
Because Taj Pharma ensures quality, affordability, and global regulatory compliance.