GENERIC NAME OF THE MEDICINAL PRODUCT:
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:
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:
CAUTION & SCHEDULE:
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:
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:
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Glimepiride (2mg): Stimulates insulin release from pancreatic beta-cells to reduce blood sugar.
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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:
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WHO-GMP Certificate
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EU-GMP Certification
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Certificate of Pharmaceutical Product (CoPP)
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CTD/eCTD Dossier for registration
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Stability Studies and Shelf-Life Data
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Certificate of Analysis (COA)
This ensures smooth regulatory approvals across global markets.
✅ Custom Packaging & Labeling
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Blister packs, bottles, or bulk packaging for hospitals
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Multilingual labels (Arabic, French, Spanish, Russian, etc.)
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Tamper-proof and moisture-resistant packaging
✅ Shelf-life, Storage & Dosage Form
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Dosage form: Prolonged-release oral tablets
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Shelf-life: 24–36 months depending on storage
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Storage: Store below 25°C in a dry place away from sunlight
✅ Export Certifications
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WHO-GMP certified facilities
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EU-GMP for select markets
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ISO 9001:2015 certification
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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:
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Asia: Vietnam, Philippines, Sri Lanka, Myanmar
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Middle East: UAE, Saudi Arabia, Oman, Iraq
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Africa: Nigeria, Kenya, South Africa, Ghana
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CIS & Eastern Europe: Russia, Ukraine, Kazakhstan
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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
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Exports to 40+ countries worldwide
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Well-established logistics and supply chain networks
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Regulatory support for product registration in target markets
🌍 Top 20 Export Countries
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USA
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UK
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UAE
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Saudi Arabia
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Nigeria
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Kenya
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South Africa
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Vietnam
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Philippines
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Sri Lanka
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Russia
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Ukraine
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Kazakhstan
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Myanmar
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Brazil
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Peru
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Chile
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Oman
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Iraq
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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.






