Gliclazide Modified Release 30mg and Metformin Hydrochloride Extended Release 500mg Tablets

Gliclazide Modified Release 30mg and Metformin Hydrochloride Extended Release 500mg Tablets  Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Gliclazide Modified Release 30mg and Metformin Hydrochloride Extended Release 500mg Tablets

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Gliclazide Modified Release 30mg and Metformin Hydrochloride Extended Release 500mg Tablets
  Each uncoated Bilayered tablet contains: 
  Gliclazide IP…………………………………30mg
  (In modified release form)
  Metformin Hydrochloride IP………………..500mg
  (In extended release form)
  Excipients………………………………………q.s
  Colour: Sunset Yellow FCF

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: Managing Diabetes with Advanced Combination Therapy

Gliclazide Modified Release 30mg and Metformin Hydrochloride Extended Release 500mg Tablets represent a powerful combination therapy for the effective management of Type 2 Diabetes Mellitus. These tablets belong to the anti-diabetic drug category and are widely prescribed to control high blood sugar levels in adults when diet and exercise alone are insufficient.

The combination of Gliclazide (a sulfonylurea) and Metformin Hydrochloride (a biguanide) works synergistically—Gliclazide increases insulin secretion from the pancreas, while Metformin enhances the body’s response to insulin and reduces glucose production in the liver.

Globally, the demand for such advanced diabetic formulations continues to grow exponentially, driven by the rising prevalence of diabetes and lifestyle-related disorders. Taj Pharma, a leading pharmaceutical manufacturer based in Vapi, Gujarat, India, has emerged as a trusted Gliclazide Modified Release 30mg and Metformin Hydrochloride Extended Release 500mg Tablets Manufacturer and Exporter, providing high-quality, affordable medicines across regulated and semi-regulated markets.

Understanding the Combination: Therapeutic Use and Benefits

Taj Pharma’s Gliclazide Modified Release 30mg and Metformin Hydrochloride Extended Release 500mg Tablets are manufactured under stringent WHO-GMP and ISO-certified facilities. This formulation helps:

• Regulate and maintain stable blood sugar levels

• Reduce the risk of diabetic complications (neuropathy, nephropathy, retinopathy)

• Enhance insulin sensitivity and pancreatic function

• Minimize fluctuations in glucose levels throughout the day

Dosage & Administration

The tablet should be taken with food, preferably at the same time daily, to maximize therapeutic benefit and minimize gastrointestinal side effects. Physicians determine the dosage based on blood sugar levels and patient response.

Precautions and Safety Advice

• Not suitable for Type 1 Diabetes Mellitus or diabetic ketoacidosis.

• Contraindicated in severe kidney or liver impairment.

• Regular monitoring of blood sugar and liver function is essential.

• Avoid alcohol as it increases the risk of hypoglycemia.

• Pregnant or breastfeeding women must consult their doctor before use.

In-depth Details for Importers, Exporters, and Global Buyers

Taj Pharma ensures end-to-end support for its international clients, making it the most reliable Gliclazide and Metformin Tablets Manufacturer and Supplier in India for regulated markets.

1. Regulatory Documentation Provided

Taj Pharma offers comprehensive technical and registration support documents including:

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP and EU-GMP Certificates

• Drug Master File (DMF) / CTD Dossier

• Certificate of Analysis (CoA)

• Free Sale Certificate

• Stability Data and Bioequivalence Studies

2. Custom Packaging & Labeling

To meet diverse global market needs, Taj Pharma provides:

• Custom packaging sizes and multilingual labeling

• Blister packs / Alu-Alu packs / HDPE bottles

• Tamper-proof and moisture-resistant packaging

• Private labeling for international distributors and PCD franchise partners

3. Shelf-life, Storage & Dosage Form

• Dosage form: Film-coated oral tablet

• Shelf-life: 24 to 36 months

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

4. Export Certifications

Taj Pharma exports its products under globally recognized certifications:

• WHO-GMP

• EU-GMP

• ISO 9001:2015

• GLP, GDP, and ISO 14001

• COPP & Dossier support for registration

5. Target Countries & Export Markets

Taj Pharma exports Gliclazide Modified Release 30mg and Metformin Hydrochloride Extended Release 500mg Tablets to more than 40 countries, including:

• Asia: Vietnam, Philippines, Sri Lanka, Myanmar

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

• CIS: Ukraine, Kazakhstan, Uzbekistan

• Middle East: Iraq, Yemen, UAE, Oman

• Latin America: Bolivia, Peru, Ecuador

• Europe: Poland, Romania, and Eastern EU nations

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

1. State-of-the-Art Manufacturing Facilities

Located in Vapi, Gujarat, Taj Pharma operates WHO-GMP-approved facilities equipped with modern technology, automated production lines, and advanced analytical laboratories ensuring consistent product quality. Every batch undergoes rigorous quality checks from raw material procurement to final dispatch.

2. Affordable Pricing & Quality Assurance

Taj Pharma combines affordability and quality through optimized manufacturing processes. With economies of scale and strict cost control, the company ensures competitive pricing without compromising efficacy, purity, or safety.

3. Global Presence & Supply Chain Support

Taj Pharma maintains a strong global supply chain network, ensuring timely deliveries and steady product availability. With efficient logistics management, Taj Pharma supports distributors, importers, and PCD franchise partners in over 40 nations.

4. Regulatory & Technical Excellence

The company’s regulatory team assists clients with dossier preparation, product registration, and export documentation — making Taj Pharma a preferred partner for global buyers looking for Gliclazide and Metformin Tablets Export from India.

5. Top 20 Export Destinations

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

Technical Product Specification

 PAN India & Global Reach

Taj Pharma has built its reputation as a leading Gliclazide Modified Release 30mg and Metformin Hydrochloride Extended Release 500mg Tablets Manufacturer and Supplier in India with a vast distribution network across Mumbai, Gujarat, Delhi, Maharashtra, and all PAN India locations.

The company also provides PCD Pharma Franchise opportunities for regional distributors and wholesalers, helping expand market reach and ensure medicine availability in every corner of the world.

Call to Action 

Are you looking for a reliable Gliclazide and Metformin Tablets Manufacturer or Exporter in India with proven quality standards, regulatory compliance, and competitive pricing?

Partner with Taj Pharma Ltd, the #1 WHO-GMP Certified Pharmaceutical Manufacturer in India, trusted by importers and healthcare professionals globally.

📞 Contact Taj Pharma:
Website: www.tajpharma.in
Email: info@tajpharma.com
Phone: +91 84484 44095 (Gen. Enq. 01)

Top 20 FAQs 

1. What is Gliclazide Modified Release 30mg and Metformin Hydrochloride Extended Release 500mg Tablets used for?
Used for managing Type 2 Diabetes Mellitus in adults when diet and exercise alone are not effective.

2. Who manufactures Gliclazide and Metformin Tablets in India?
Taj Pharma Ltd, based in Vapi, Gujarat, is a leading WHO-GMP-certified manufacturer and exporter.

3. Is this medicine suitable for Type 1 Diabetes?
No, it is only for Type 2 Diabetes Mellitus.

4. What is the mechanism of action?
Gliclazide increases insulin secretion, while Metformin reduces hepatic glucose production.

5. Can I take this medicine on an empty stomach?
No, it should always be taken with food to avoid gastric discomfort.

6. What are the common side effects?
Nausea, headache, dizziness, hypoglycemia, and mild gastrointestinal disturbances.

7. How should it be stored?
Keep in a cool, dry place below 25°C away from sunlight.

8. What certifications does Taj Pharma hold?
WHO-GMP, ISO, COPP, and CTD Dossier support for global registration.

9. What is the shelf-life of these tablets?
Typically 24 to 36 months under recommended storage conditions.

10. Can pregnant women use it?
Only under the supervision of a qualified medical practitioner.

11. Is it safe for long-term use?
Yes, when prescribed and monitored by a doctor.

12. What countries does Taj Pharma export to?
Over 40 countries across Asia, Africa, Europe, and Latin America.

13. What is the packaging type available?
Blister and Alu-Alu packs in 10×10 or 30×10 formats.

14. Can it be co-administered with other anti-diabetic drugs?
Yes, but only under a doctor’s supervision.

15. What should I do if I miss a dose?
Take it as soon as you remember unless it’s near the next dose.

16. How does Taj Pharma ensure quality?
Every batch is tested in WHO-GMP-approved quality control labs.

17. Does Taj Pharma offer private labeling?
Yes, with customized packaging and branding for global partners.

18. Is the product bioequivalent to branded versions?
Yes, it meets international bioequivalence and stability standards.

19. What is the export support process?
Taj Pharma provides dossiers, COPPs, and registration support for importers.

20. How can I place a bulk export order?
Contact Taj Pharma’s export division directly via their website or official email.

Taj Pharma Ltd stands as India’s most trusted Gliclazide Modified Release 30mg and Metformin Hydrochloride Extended Release 500mg Tablets Manufacturer and Supplier, delivering uncompromised quality, affordability, and global regulatory compliance.

With a commitment to innovation and patient well-being, Taj Pharma continues to strengthen its leadership in diabetes management solutions, serving the global healthcare community with integrity and excellence.