Gliclazide Modified Release 80mg and Metformin Hydrochloride Extended Release 500mg Tablets 

Gliclazide Modified Release 80mg and Metformin Hydrochloride Extended Release 500mg Tablets  Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Gliclazide Modified Release 80mg and Metformin Hydrochloride Extended Release 500mg Tablets

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Gliclazide Modified Release 80mg and Metformin Hydrochloride Extended Release 500mg Tablets
  Each uncoated Bilayered tablet contains: 
  Gliclazide IP…………………………………80mg
  (In modified release form)
  Metformin Hydrochloride IP………………..500mg
  (In extended release form)
  Excipients………………………………………q.s
  Colour: Quinoline Yellow WS

THERAPEUTIC INDICATIONS:

Gliclazide + Metformin is a combination of two antidiabetic medicines. Gliclazide is a sulfonylurea which works by increasing the amount of insulin released by the pancreas in order to lower the blood glucose. Metformin is a biguanide which works by lowering glucose production in the liver, delaying glucose absorption from intestines and increasing the body’s sensitivity to insulin.

CAUTION & SCHEDULE:

CAUTION:  Read enclosed leaflet before use.
Keep medicine out of reach of children.
Tablet to be swallowed as a whole, and not to be chewed or crushed. 

SCHEDULE H PRESCRIPTION DRUG- CAUTION: Not to be sold by retail without the prescription of a registered medical practitioner.

SCHEDULE G PRESCRIPTION DRUG- CAUTION: It is dangerous to take the prescription except under medical supervision. 

STORAGE & DOSAGE:

Storage: Store at temperature not exceeding 25℃.
Store in cool, dry & dark place.
Protect from Light & moisture.

Dosage:  As directed by the Physician.

Introduction

Gliclazide Modified Release 80mg and Metformin Hydrochloride Extended Release 500mg Tablets are a trusted combination therapy for managing Type 2 Diabetes Mellitus. This formulation combines two well-established anti-diabetic agents — Gliclazide, a sulfonylurea that stimulates insulin secretion, and Metformin, a biguanide that reduces glucose production in the liver. Together, they provide effective and sustained control of blood glucose levels, improving patient outcomes.

Among the leading global manufacturers, Taj Pharma Ltd. stands out as the best Gliclazide Modified Release 80mg and Metformin Hydrochloride Extended Release 500mg Tablets Manufacturer in India. Based in Vapi, Gujarat, Taj Pharma is recognized globally for its adherence to WHO-GMP, EU-GMP, and ISO-certified standards, providing safe, effective, and affordable pharmaceutical formulations for international markets.

Understanding Gliclazide MR and Metformin HCl ER Tablets

Gliclazide Modified Release 80mg and Metformin Hydrochloride Extended Release 500mg Tablets belong to a class of oral hypoglycemic agents that control high blood sugar in adults with Type 2 Diabetes Mellitus.

These tablets are particularly effective in patients where diet and exercise alone are insufficient. They help maintain stable blood glucose levels throughout the day, reducing risks of diabetic complications such as neuropathy, nephropathy, retinopathy, and cardiovascular diseases.

• Gliclazide (MR 80mg): Promotes controlled insulin release to regulate blood glucose levels.

• Metformin (ER 500mg): Decreases glucose production by the liver and enhances insulin sensitivity.

Both agents work synergistically to provide superior glycemic control while minimizing fluctuations and hypoglycemia risk.

The Trusted Manufacturer, Supplier & Exporter

Taj Pharma Ltd India is a WHO-GMP-certified manufacturer, supplier, and exporter of Gliclazide Modified Release 80mg and Metformin Hydrochloride Extended Release 500mg Tablets from Vapi, Gujarat, India.

With decades of excellence in pharmaceutical formulation development, Taj Pharma has become a symbol of quality and trust across global markets, providing medicines that meet the highest international quality and safety standards.

Taj Pharma ensures:

• Stringent Quality Assurance (QA) and Quality Control (QC) processes.

• Regulatory-compliant packaging and labeling.

• Flexible contract manufacturing and PCD franchise opportunities for domestic and international buyers.

How to Take Gliclazide MR 80mg and Metformin ER 500mg Tablets

These tablets should be taken with food, ideally at the same time every day. Consistent dosing helps achieve maximum therapeutic benefits and stable blood sugar control.
Dosage should be determined by a physician based on individual blood glucose levels and medical response.

Patients should not discontinue therapy abruptly, as this could lead to elevated blood glucose and increase the risk of long-term diabetic complications.

Common Side Effects

While generally well-tolerated, some patients may experience mild side effects such as:

• Low blood sugar (hypoglycemia)

• Nausea or vomiting

• Diarrhea

• Constipation

• Headache or dizziness

Maintaining a regular meal schedule, avoiding alcohol, and monitoring glucose levels can help minimize adverse effects.

Precautions & Safety Advice

• Avoid use in Type 1 diabetes mellitus or diabetic ketoacidosis.

• Contraindicated in patients with severe kidney or liver impairment.

• Pregnant or lactating women should consult their physician before use.

• Regular liver function and blood glucose monitoring is advised during treatment.

Regulatory Documentation and Export Compliance

Taj Pharma provides comprehensive export documentation for global buyers and regulatory agencies, ensuring smooth import registration and market entry.

Regulatory Documents Include:

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP / EU-GMP Certificates

• CTD / ACTD Dossiers

• Product stability and bioequivalence data

• Free Sale Certificate (FSC)

• Certificate of Analysis (COA)

• Batch Manufacturing Records (BMR)

• Packing and Labeling Artwork approvals

Taj Pharma also offers customized labeling and multilingual packaging as per country-specific requirements.

Shelf Life, Storage, and Dosage Form

Export Certifications and Global Reach

Taj Pharma’s formulations are exported to over 80 countries across Asia, Africa, Latin America, the Middle East, and CIS nations.

The company holds prestigious certifications that demonstrate its international quality compliance:

• WHO-GMP Certified Facilities

• EU-GMP & PIC/S Standards

• ISO 9001:2015 Certification

• COFEPRIS, NMPA, and INVIMA Registrations for selective markets

Taj Pharma ensures that every consignment meets Good Distribution Practices (GDP) and is backed by complete export documentation for hassle-free customs clearance.

Target Export Markets

Taj Pharma exports Gliclazide Modified Release 80mg and Metformin Hydrochloride Extended Release 500mg Tablets to:

USA, UK, South Africa, Kenya, Nigeria, Ghana, Vietnam, Myanmar, Philippines, Bangladesh, Sri Lanka, Iraq, Yemen, Uzbekistan, Kazakhstan, Georgia, Peru, Bolivia, Ukraine, Cambodia

Why Taj Pharma is the Most Trusted Manufacturer & Exporter

1. WHO-GMP Certified Manufacturing Facilities

Taj Pharma’s production plant in Vapi, Gujarat, adheres to WHO-GMP and EU-GMP guidelines, ensuring each batch is manufactured in a sterile, quality-controlled environment.

2. Affordable Pricing with Global Quality

Taj Pharma combines cost efficiency with premium-grade materials, making it a preferred pharma exporter from India for developing and regulated markets alike.

3. Global Supply Chain Strength

With a strong global logistics network and export compliance team, Taj Pharma ensures timely deliveries and consistent availability of life-saving medicines.

4. Customer-Centric Services

Offering custom packaging, regulatory support, private labeling, and contract manufacturing, Taj Pharma is the partner of choice for distributors, importers, and PCD franchise holders worldwide.

Technical Product Specification Table

Call to Action  

If you’re a pharmaceutical distributor, importer, or government procurement agency, looking for a reliable and WHO-GMP-certified manufacturer of Gliclazide Modified Release 80mg and Metformin Hydrochloride Extended Release 500mg Tablets in India, Taj Pharma Ltd. is your trusted partner.

📞 Contact Taj Pharma Today:
Email: info@tajpharma.com
Website: www.tajpharma.com
Address: Taj Pharma Ltd., Vapi, Gujarat, India

Top 20 FAQs  

1. What are Gliclazide MR and Metformin ER Tablets used for?
They are used for managing Type 2 Diabetes Mellitus to maintain healthy blood glucose levels.

2. Who manufactures these tablets in India?
Taj Pharma Ltd. is a leading WHO-GMP-certified manufacturer and exporter in India.

3. Are these tablets safe for long-term use?
Yes, when used as prescribed under medical supervision.

4. What is the dosage?
Typically, one tablet daily with food, as directed by your doctor.

5. Can I take alcohol while using this medicine?
No, alcohol increases the risk of hypoglycemia.

6. Are these tablets available for export?
Yes, Taj Pharma exports globally with full regulatory documentation.

7. What packaging options are available?
Alu-Alu and Blister packs, customizable for different markets.

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

9. What certifications does Taj Pharma hold?
WHO-GMP, EU-GMP, ISO 9001:2015, and COPP certificates.

10. What is the shelf life of the tablets?
24–36 months from the date of manufacture.

11. What are the key side effects?
Low blood sugar, nausea, constipation, and mild headache.

12. Are these suitable for children?
No, they are recommended for adults with Type 2 Diabetes only.

13. How should I store the tablets?
Store in a cool, dry place below 25°C.

14. Can pregnant women take this medicine?
Only under medical supervision.

15. What is Taj Pharma’s export capacity?
Over 80 countries across 5 continents.

16. What documentation is provided for registration?
COPP, COA, Stability data, CTD dossier, etc.

17. Are samples available?
Yes, samples are provided for regulatory and tender purposes.

18. Does Taj Pharma offer PCD Pharma Franchise?
Yes, nationwide franchise opportunities are available.

19. How can I import these tablets?
Through a valid import license, supported by Taj Pharma’s export team.

20. Why choose Taj Pharma?
For quality, affordability, documentation support, and global trust.