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 (4mg+100mg) 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 (4mg+100mg)

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets IP (4mg+100mg)
    Each uncoated tablet contains:
    Glimepiride IP……………………………………….4mg
    Metformin Hydrochloride IP………………………..100mg
    (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.

Introduction to Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (4mg+100mg)

Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (4mg+100mg) are a highly effective combination therapy prescribed worldwide for managing Type 2 diabetes mellitus. This formulation combines Glimepiride (4mg), which stimulates the pancreas to release insulin, with Metformin (100mg), which decreases liver glucose production and improves insulin sensitivity in peripheral tissues.

Globally, the prevalence of Type 2 diabetes is increasing rapidly, driving demand for combination therapies that improve glycemic control. Glimepiride + Metformin Prolonged-Release Tablets are recognized for their efficacy, safety, and convenience, particularly in patients who struggle with blood sugar management on monotherapy.

Taj Pharma, as a trusted Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (4mg+100mg) manufacturer in India, plays a critical role in meeting the global demand for high-quality, cost-effective antidiabetic medications.


In-depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided

Taj Pharma ensures full regulatory compliance for international markets, providing comprehensive documentation packages:

  • WHO-GMP Certificates

  • EU-GMP Certification

  • Certificate of Pharmaceutical Product (COPP)

  • CTD Dossiers for regulatory submission

  • Free Sale Certificates

  • Stability and batch-wise COA (Certificate of Analysis)

These documents facilitate smooth registration and import approval for buyers across regulated and semi-regulated markets.

Custom Packaging & Labeling

Understanding diverse export requirements, Taj Pharma offers:

  • Custom blister packs, strip packs, or bottles

  • Multilingual labeling for target countries

  • Tamper-proof, export-compliant packaging

  • Branding solutions for PCD franchise partners and distributors

Shelf-Life, Storage & Dosage Form

  • Shelf-life: 24–36 months depending on country-specific regulations

  • Dosage form: Prolonged-release oral tablets

  • Storage conditions: Store at room temperature, protect from moisture and direct sunlight

Export Certifications

Taj Pharma adheres to international quality standards:

  • WHO-GMP certified manufacturing units

  • EU-GMP approved facilities

  • ISO Certification for quality management

  • COPP for international trade compliance

  • CTD dossiers for smooth regulatory approvals

Target Countries & Export Markets

Taj Pharma exports Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (4mg+100mg) to countries across:

  • Asia: Philippines, Vietnam, Sri Lanka, Myanmar

  • Africa: Nigeria, Kenya, Ghana, South Africa

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

  • Latin America: Peru, Chile, Bolivia, Guatemala

  • CIS & Eastern Europe: Ukraine, Georgia, Kazakhstan

This wide distribution network ensures timely deliveries and consistent supply for global buyers.


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

1. State-of-the-Art Manufacturing

Taj Pharma’s WHO-GMP and EU-GMP certified facilities in Vapi, Gujarat, India, feature modern equipment and strict quality control systems. Every batch of Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets undergoes rigorous testing for purity, potency, and consistency.

2. Affordable Pricing with Quality Assurance

By leveraging efficient production methods and economies of scale, Taj Pharma offers cost-effective pricing while maintaining world-class quality assurance standards, making it ideal for distributors, hospitals, and government tenders.

3. Global Presence & Supply Chain Support

Taj Pharma has established a robust international supply chain, ensuring reliable and timely delivery across 70+ countries. Its logistics and warehouse management systems guarantee product stability during transit.

4. Top 20 Countries Exporting

  1. Nigeria

  2. Kenya

  3. Ghana

  4. South Africa

  5. Philippines

  6. Vietnam

  7. Sri Lanka

  8. Myanmar

  9. UAE

  10. Saudi Arabia

  11. Oman

  12. Qatar

  13. Ukraine

  14. Kazakhstan

  15. Bolivia

  16. Peru

  17. Chile

  18. Guatemala

  19. Bangladesh

  20. Nepal

This extensive global footprint reflects Taj Pharma’s trustworthiness and reliability as a leading Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (4mg+100mg) exporter from India.


Technical Product Specification Table

Parameter Details
Product Name Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (4mg+100mg)
Composition Glimepiride 4mg + Metformin Hydrochloride 100mg
Dosage Form Prolonged-release oral tablets
Therapeutic Category Antidiabetic / Oral hypoglycemic agent
Indications Type 2 diabetes mellitus (as combination therapy)
Shelf Life 24–36 months
Packaging Blister packs, strip packs, bottles
Certifications WHO-GMP, EU-GMP, ISO, COPP
Manufacturer Taj Pharma, Vapi, Gujarat, India

Call to Action for Buyers/Distributors

For businesses seeking high-quality Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (4mg+100mg) manufacturer in India, Taj Pharma provides:

  • WHO-GMP certified formulations

  • Affordable pricing for bulk orders

  • Custom packaging and labeling

  • Reliable international logistics and supply chain support

📩 Contact Taj Pharma today to partner with a globally recognized pharmaceutical manufacturer:
Email: info@tajpharma.com
Website: www.tajpharma.com


Top 20 FAQs on Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (4mg+100mg)

Q1. What is Glimepiride and Metformin Hydrochloride Prolonged-Release Tablets (4mg+100mg) used for?
A: It is used to manage Type 2 diabetes mellitus by controlling blood sugar levels.

Q2. Who is the leading manufacturer in India?
A: Taj Pharma is the most trusted manufacturer and exporter.

Q3. How does the medication work?
A: Glimepiride stimulates insulin release, and Metformin improves insulin sensitivity and decreases liver glucose production.

Q4. Can it cause hypoglycemia?
A: Yes, especially if taken with other antidiabetic drugs, alcohol, or missed meals.

Q5. What is the shelf life of the product?
A: 24–36 months under proper storage conditions.

Q6. Are WHO-GMP and EU-GMP certifications available?
A: Yes, all batches are manufactured under WHO-GMP and EU-GMP standards.

Q7. Can it be used as monotherapy?
A: No, it is indicated as a combination therapy for better glycemic control.

Q8. How should it be stored?
A: Store at room temperature, away from sunlight and moisture.

Q9. What packaging options are offered?
A: Blister packs, strip packs, and bottles with export-compliant labeling.

Q10. Is it suitable for global export?
A: Yes, Taj Pharma supplies to more than 70 countries worldwide.

Q11. Can it be supplied for government tenders?
A: Yes, Taj Pharma participates in international government procurement programs.

Q12. Can distributors opt for private labeling?
A: Yes, custom packaging and labeling are available for franchise partners.

Q13. Are stability and batch analysis certificates provided?
A: Yes, all batches include COA and stability data.

Q14. Is the medicine safe for long-term use?
A: Yes, under medical supervision with regular blood sugar monitoring.

Q15. Can it be exported to Africa?
A: Yes, countries like Nigeria, Kenya, Ghana, and South Africa are served.

Q16. Is it available for PCD franchise?
A: Yes, Taj Pharma provides PCD franchise opportunities.

Q17. What are common side effects?
A: Hypoglycemia, nausea, gastrointestinal disturbances, and mild headache.

Q18. How does prolonged-release benefit patients?
A: It ensures sustained blood sugar control and reduces dosing frequency.

Q19. How to order in bulk?
A: Contact Taj Pharma’s export team via email or website for quotations.

Q20. Does Taj Pharma offer technical support to buyers?
A: Yes, technical support and regulatory guidance are provided for all international clients.