Gliclazide Modified Release 60mg and Metformin Hydrochloride Extended Release 500mg Tablets

Gliclazide Modified Release 60mg and Metformin Hydrochloride Extended Release 500mg Tablets  Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Gliclazide Modified Release 60mg and Metformin Hydrochloride Extended Release 500mg Tablets

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Gliclazide Modified Release 60mg and Metformin Hydrochloride Extended Release 500mg Tablets
  Each uncoated Bilayered tablet contains: 
  Gliclazide IP…………………………………60mg
  (In modified release form)
  Metformin Hydrochloride IP………………..500mg
  (In extended release form)
  Excipients………………………………………q.s
  Colour: Red Oxide Of Iron, Yellow Oxide Of Iron

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.

Gliclazide Modified Release 60mg and Metformin Hydrochloride Extended Release 500mg Tablets Manufacturer in India

Taj Pharma, the well-known Gliclazide Modified Release 60mg and Metformin Hydrochloride Extended Release 500mg Tablets manufacturer in India, ensures high-quality, efficacy, and purity in every batch. This advanced formulation belongs to the class of anti-diabetic drugs and is used for the management of Type 2 Diabetes Mellitus in adults. It effectively helps control blood sugar levels, providing a stable and sustained release for optimal glycemic control.

Understanding Gliclazide Modified Release 60mg and Metformin Hydrochloride Extended Release 500mg Tablets

Gliclazide is a sulfonylurea derivative that enhances insulin secretion, while Metformin Hydrochloride improves insulin sensitivity and reduces hepatic glucose production. This dual mechanism delivers long-lasting glucose control and minimizes fluctuations in blood sugar levels.

The combination is specially formulated as modified and extended release, ensuring that therapeutic levels are maintained for an extended duration—improving compliance and convenience for diabetic patients.

A Trusted Name in Global Pharmaceutical Manufacturing

Taj Pharma Ltd, India, is a well-recognized Manufacturer, Exporter, and Supplier of Gliclazide Modified Release 60mg and Metformin Hydrochloride Extended Release 500mg Tablets from Vapi, Gujarat, India. With its state-of-the-art WHO-GMP and ISO-certified manufacturing facility, Taj Pharma consistently delivers pharmaceutical formulations that meet international quality benchmarks.

This formulation should be taken with food, ideally at the same time each day, to ensure the best results. Doctors may adjust the dosage based on blood glucose response and individual tolerance.

Benefits of Choosing Taj Pharma as Your Manufacturing Partner

Taj Pharma’s commitment to quality, innovation, and affordability has made it one of the most trusted global suppliers of pharmaceutical formulations. For international buyers, importers, and distributors, Taj Pharma offers unmatched advantages:

• Regulatory Support: Provides CTD Dossiers, WHO-GMP, EU-GMP, and COPP certificates.

• Flexible Packaging: Custom blister packs, bottles, or strips according to client country regulations.

• Private Labeling: White-label manufacturing for global brands.

• Strong Supply Chain: Robust export logistics with guaranteed timelines.

• Quality Control: Advanced analytical testing and validation systems ensure purity and consistency.

Therapeutic Indications and Dosage Information

This combination tablet is prescribed for Type 2 Diabetes Mellitus, particularly when diet, exercise, and monotherapy are insufficient to control blood glucose.

Dosage: One tablet daily with meals (as directed by a physician).
Important: Do not skip doses or discontinue without consulting your healthcare provider.

Patient Guidance and Safety Information

Continue taking this medicine even when your blood sugar appears normal. Sudden discontinuation may result in hyperglycemia, leading to long-term complications such as neuropathy, kidney damage, and vision loss.

Maintain a balanced diet, engage in regular physical activity, and monitor your blood sugar levels as advised.

Avoid alcohol consumption, as it can increase the risk of hypoglycemia. Report any symptoms of dizziness, sweating, or fatigue to your physician immediately.

Side Effects and Precautions

The most common side effects include:

• Mild hypoglycemia

• Nausea or vomiting

• Stomach pain or diarrhea

• Headache

• Constipation or taste changes

Avoid using the medicine if you have:

• Type 1 Diabetes Mellitus

• Diabetic ketoacidosis

• Severe renal or hepatic impairment

• Heart failure (without medical supervision)

Pregnant and breastfeeding women should consult their physician before use.

Gliclazide Modified Release 60mg and Metformin Hydrochloride Extended Release 500mg Tablets for Export

Taj Pharma supplies this formulation globally to regulated and semi-regulated markets under WHO-GMP, EU-GMP, and PICS compliance. All export documentation, including COA, COPP, Stability Data, and CTD Dossiers, are provided to support regulatory submissions.

Target Export Markets:

India | Sri Lanka | Vietnam | Philippines | Myanmar | UAE | Kenya | Nigeria | Ghana | Ethiopia | South Africa | Russia | Ukraine | Iraq | Cambodia | Nepal | Chile | Peru | Bolivia | Mexico

Why Taj Pharma is the Best Gliclazide + Metformin Manufacturer & Exporter in India

1. State-of-the-Art Manufacturing

Taj Pharma’s manufacturing facility in Vapi, Gujarat, complies with WHO-GMP, EU-GMP, and ISO 9001:2015 standards. Each product undergoes rigorous testing to ensure therapeutic consistency.

2. Affordable and Accessible

Taj Pharma focuses on affordability without compromising quality, making life-saving medications accessible to global markets.

3. Regulatory Excellence

Complete documentation support (CTD, ACTD, DMF, BE Studies) for seamless product registration worldwide.

4. Global Presence

Exports to more than 80 countries with strong distributor partnerships in Asia, Africa, Latin America, and CIS regions.

5. Trusted by Healthcare Professionals

Recognized by global buyers and healthcare experts as a reliable source of anti-diabetic formulations.

Technical Product Specification

 Export Capabilities

Taj Pharma is among the top WHO-GMP pharmaceutical manufacturers in India and maintains an expansive export network. The company holds global certifications and approvals, ensuring seamless export to international markets.

• Regulatory Documentation: COPP, FSC, COA, CTD/ACTD Dossiers

• Packaging Options: Customized per import country regulations

• Labeling: Multilingual labels available for international compliance

• MOQ Flexibility: Small and bulk order capacity

 Call to Action

Are you a pharma importer, distributor, or PCD partner seeking a reliable Gliclazide Modified Release 60mg and Metformin Hydrochloride Extended Release 500mg Tablets Manufacturer in India?

Contact Taj Pharma Ltd today to discuss export partnerships, private labeling, and bulk supply opportunities.

📧 Email: info@tajpharma.com
🌐 Website: www.tajpharma.in
📞 Phone: +9122-2634 1274
📍 Address: Taj Pharma Ltd., Vapi, Gujarat, India

 Top 20 FAQs 

1. What are Gliclazide MR and Metformin ER tablets used for?
They are used to manage Type 2 Diabetes Mellitus by improving insulin sensitivity and controlling blood sugar levels.

2. Who manufactures Gliclazide + Metformin tablets in India?
Taj Pharma Ltd is a leading WHO-GMP manufacturer of this combination in India.

3. Can I take this medicine on an empty stomach?
No, it should be taken with meals to reduce gastrointestinal side effects.

4. Is it safe during pregnancy?
Consult your doctor before using this medication during pregnancy.

5. What are the common side effects?
Hypoglycemia, nausea, vomiting, diarrhea, and dizziness.

6. Can alcohol be consumed with this medication?
Avoid alcohol; it can increase the risk of hypoglycemia.

7. How long can I use this medicine?
As long as prescribed by your physician, with regular monitoring.

8. Is Taj Pharma WHO-GMP certified?
Yes, Taj Pharma operates WHO-GMP, EU-GMP, and ISO-certified facilities.

9. Can I order in bulk for export?
Yes, Taj Pharma supplies in bulk and offers custom packaging.

10. Is it available for private labeling?
Yes, private label manufacturing is available for global distributors.

11. What is the shelf life?
24 months from the date of manufacture.

12. What is the dosage strength available?
Gliclazide 60mg (MR) + Metformin 500mg (ER).

13. Which countries import from Taj Pharma?
Taj Pharma exports to 80+ countries including Kenya, UAE, Sri Lanka, and Russia.

14. What documentation is provided for export?
COA, COPP, CTD Dossier, Stability Data, and Packaging Insert.

15. What is the minimum order quantity (MOQ)?
MOQ is flexible as per buyer requirements.

16. Are samples available?
Yes, export samples can be provided for evaluation.

17. How is the medicine packaged?
Typically in 10×10 Alu-Alu blisters; custom packs available.

18. Can distributors get monopoly rights?
Yes, under the PCD Pharma Franchise model.

19. How to store the product?
Store below 30°C, in a dry and cool place.

20. Why choose Taj Pharma?
For trusted quality, global certifications, and reliable export support.