GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets IP (1mg+500mg)
B. Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets IP (2mg+500mg)
C. Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets IP (4mg+500mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets IP (1mg+500mg)
Each uncoated tablet contains:
Glimepiride IP……………………………………….1mg
Metformin Hydrochloride IP…………..500mg
(In Prolonged release form)
Excipients………………………………………q.s
Colour: Yellow Oxide of Iron

B) Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets IP (2mg+500mg)
Each uncoated tablet contains:
Glimepiride IP……………………………………….2mg
Metformin Hydrochloride IP…………..500mg
(In Prolonged release form)
Excipients………………………………………q.s
Colour: Red Oxide of Iron


C) Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets IP (4mg+500mg)
Each uncoated tablet contains:
Glimepiride IP……………………………………….4mg
Metformin Hydrochloride IP…………..500mg
(In Prolonged release form)
Excipients………………………………………q.s
Colour: Quinoline Yellow WS

THERAPEUTIC INDICATIONS:

Glimepiride + Metformin is a combination of two medicines: Glimepiride and Metformin. This medicine is used in the treatment of type 2 diabetes mellitus (DM). It improves blood glucose levels in adults when taken along with proper diet and regular exercise.

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

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

STORAGE & DOSAGE:

Storage: Store at temperature not exceeding 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by the Physician.

Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (2mg+500mg) Technical Specification:

Product Name: Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets IP
Brand Name: Generic
Strength: (1mg+500mg), (2mg+500mg), (4mg+100mg)
Dosage Form: Tablets (uncoated)
Route of Administration: Via Oral Route
Packing: 10 strips of 10 tablets each
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Regulatory Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Antidiabetic
Indication: Glimepiride + Metformin is a combination of two medicines: Glimepiride and Metformin. This medicine is used in the treatment of type 2 diabetes mellitus (DM). It improves blood glucose levels in adults when taken along with proper diet and regular exercise.
Storage: Store at temperature not exceeding 30℃. Store in cool, dry & dark place. Protect from Light & moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets IP (2mg+500mg)

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets IP (2mg+500mg)
    Each uncoated tablet contains:
    Glimepiride IP……………………………………….2mg
    Metformin Hydrochloride IP………………………..500mg
    (In Prolonged release form)
    Excipients…………………………………………..q.s
    Colour: Red Oxide of Iron

THERAPEUTIC INDICATIONS:

Glimepiride + Metformin is a combination of two medicines: Glimepiride and Metformin. This medicine is used in the treatment of type 2 diabetes mellitus (DM). It improves blood glucose levels in adults when taken along with proper diet and regular exercise.

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

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

STORAGE & DOSAGE:

Storage: Store at temperature not exceeding 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.

Dosage: As directed by the Physician.

Introduction to Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (2mg+500mg)

Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (2mg+500mg) is a combination antidiabetic medication designed for Type 2 diabetes mellitus management. This dual-action therapy includes:

  • Glimepiride (2mg): Stimulates insulin release from pancreatic beta-cells to reduce blood sugar.

  • Metformin Hydrochloride (500mg): Reduces hepatic glucose production and improves insulin sensitivity in peripheral tissues.

This combination is particularly effective in controlling blood glucose levels better than metformin alone. Patients are advised to maintain a healthy lifestyle including proper diet and regular exercise while taking this medication.

Globally, the prevalence of Type 2 diabetes is increasing at an alarming rate, fueling the demand for combination antidiabetic therapies like Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (2mg+500mg). Pharmaceutical buyers, distributors, and importers seek reliable manufacturers from India, which is recognized as a hub for high-quality, affordable, WHO-GMP certified medicines.


In-Depth Details for Importers, Exporters & Buyers

When sourcing Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (2mg+500mg) from India, buyers require regulatory compliance, packaging flexibility, shelf-life assurance, and export documentation. Taj Pharma fulfills all these requirements.

✅ Regulatory Documentation Provided

Taj Pharma provides comprehensive documentation for international importers:

  • WHO-GMP Certificate

  • EU-GMP Certification

  • Certificate of Pharmaceutical Product (CoPP)

  • CTD/eCTD Dossier for registration

  • Stability Studies and Shelf-Life Data

  • Certificate of Analysis (COA)

This ensures smooth regulatory approvals across global markets.

✅ Custom Packaging & Labeling

  • Blister packs, bottles, or bulk packaging for hospitals

  • Multilingual labels (Arabic, French, Spanish, Russian, etc.)

  • Tamper-proof and moisture-resistant packaging

✅ Shelf-life, Storage & Dosage Form

  • Dosage form: Prolonged-release oral tablets

  • Shelf-life: 24–36 months depending on storage

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

✅ Export Certifications

  • WHO-GMP certified facilities

  • EU-GMP for select markets

  • ISO 9001:2015 certification

  • COPP certificates for import/export compliance

✅ Target Countries & Export Markets

Taj Pharma exports Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (2mg+500mg) to regulated and semi-regulated markets including:

  • Asia: Vietnam, Philippines, Sri Lanka, Myanmar

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

  • Africa: Nigeria, Kenya, South Africa, Ghana

  • CIS & Eastern Europe: Russia, Ukraine, Kazakhstan

  • Latin America: Brazil, Peru, Chile


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

🌐 State-of-the-Art Manufacturing

Taj Pharma operates from Vapi, Gujarat, with WHO-GMP certified facilities. Modern automated production lines, advanced quality control laboratories, and rigorous testing protocols ensure high-quality, safe, and effective antidiabetic tablets.

💲 Affordable Pricing with Quality Assurance

As a top Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (2mg+500mg) manufacturer in India, Taj Pharma delivers competitive pricing while adhering to international quality standards.

🚚 Global Presence & Supply Chain Support

  • Exports to 40+ countries worldwide

  • Well-established logistics and supply chain networks

  • Regulatory support for product registration in target markets

🌍 Top 20 Export Countries

  1. USA

  2. UK

  3. UAE

  4. Saudi Arabia

  5. Nigeria

  6. Kenya

  7. South Africa

  8. Vietnam

  9. Philippines

  10. Sri Lanka

  11. Russia

  12. Ukraine

  13. Kazakhstan

  14. Myanmar

  15. Brazil

  16. Peru

  17. Chile

  18. Oman

  19. Iraq

  20. Ghana


Technical Product Specification Table

Parameter Details
Product Name Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (2mg+500mg)
Manufacturer Taj Pharma Ltd., Vapi, Gujarat, India
Active Ingredients Glimepiride 2mg + Metformin Hydrochloride 500mg
Dosage Form Prolonged-release oral tablets
Therapeutic Class Antidiabetic / Type 2 Diabetes
Packaging Options Blister packs, bottles, bulk packs
Shelf-life 24–36 months
Storage Conditions Below 25°C, away from sunlight & humidity
Certifications WHO-GMP, EU-GMP, ISO 9001:2015, CoPP
Indications Type 2 diabetes management
Side Effects Hypoglycemia, nausea, dizziness, headache, GI disturbances

If you are searching for a trusted Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (2mg+500mg) manufacturer in India for global distribution, government tenders, or PCD Pharma Franchise, Taj Pharma is your reliable partner.

📞 Contact Taj Pharma today to request samples, price quotations, or regulatory documents.
🌐 Visit: www.tajpharma.com


Top 20 FAQs

Q1: What is Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (2mg+500mg) used for?
A1: It manages Type 2 diabetes by reducing blood sugar and improving insulin sensitivity.

Q2: Who is the manufacturer?
A2: Taj Pharma Ltd., Vapi, Gujarat, India, a WHO-GMP certified manufacturer.

Q3: Are these tablets exported worldwide?
A3: Yes, Taj Pharma exports to over 40 countries.

Q4: What is the shelf life?
A4: 24–36 months depending on storage conditions.

Q5: Can it cause hypoglycemia?
A5: Yes, especially with other antidiabetic medicines, alcohol, or missed meals.

Q6: Does Taj Pharma provide CTD dossiers?
A6: Yes, full CTD/eCTD dossiers are available for import and registration.

Q7: Are custom labels and packaging available?
A7: Yes, Taj Pharma provides multilingual packaging and export-grade options.

Q8: Is it safe with other diabetes medications?
A8: It should be taken under physician supervision to avoid hypoglycemia.

Q9: Can distributors get PCD Pharma Franchise?
A9: Yes, Taj Pharma offers PAN-India PCD Pharma Franchise opportunities.

Q10: What certifications does Taj Pharma hold?
A10: WHO-GMP, EU-GMP, ISO 9001:2015, and CoPP.

Q11: What are common side effects?
A11: Hypoglycemia, nausea, headache, dizziness, and GI disturbances.

Q12: Is it better than metformin alone?
A12: Yes, the combination improves glycemic control more effectively than metformin monotherapy.

Q13: Can it be supplied in bulk?
A13: Yes, Taj Pharma handles bulk orders for global distributors and tenders.

Q14: What is the recommended dosage?
A14: As prescribed by a physician, typically once or twice daily with meals.

Q15: Does Taj Pharma supply to hospitals?
A15: Yes, hospital and institutional bulk packaging is available.

Q16: Can it be exported to regulated markets?
A16: Yes, with full WHO-GMP and EU-GMP certifications.

Q17: What packaging formats are offered?
A17: Blister packs, HDPE bottles, and bulk packing.

Q18: Can I request samples for registration?
A18: Yes, Taj Pharma provides samples for regulatory filings.

Q19: Are these tablets suitable for long-term use?
A19: Yes, under regular medical supervision and lifestyle management.

Q20: Why choose Taj Pharma over other manufacturers?
A20: Due to high-quality WHO-GMP manufacturing, affordability, global reach, regulatory support, and reliable supply chain.