Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 1000mg Tablets

Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 1000mg Tablets Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 1000mg Tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 1000mg Tablets
  Each uncoated Bilayered tablet contains:
  Teneligliptin Hydrochloride Hydrate
  Equivalent to Teneligliptin……………….20mg
  Metformin Hydrochloride IP…………….1000mg
  (As Extended Release)
  Excipients………………………………………q.s
  Colours: Ferric oxide Red USP-NF
  (Red Oxide of iron)
  (In Teneligliptin layer)

 THERAPEUTIC INDICATIONS:

METFORMIN+TENELIGLIPTIN belongs to the group of medications called ‘antidiabetic agents’ used to treat Type 2 diabetes mellitus. This medication improves glycemic control in diabetic patients in those patients who do not react well to Metformin alone.

 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.

WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store below 25℃.
Store in cool, dry & dark place.
Protect from Light & moisture.

Dosage: As directed by the Physician.

Introduction: Managing Type 2 Diabetes with Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 1000mg Tablets

Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 1000mg Tablets are a combination oral antidiabetic medication used to manage blood glucose levels in adults with type 2 diabetes mellitus. The formulation combines the power of Teneligliptin, a DPP-4 inhibitor, and Metformin Hydrochloride (Extended Release), a biguanide, to effectively lower blood sugar levels and improve glycemic control.

This combination therapy works synergistically:

• Teneligliptin increases insulin secretion and suppresses glucagon release.

• Metformin (ER) decreases hepatic glucose production and enhances insulin sensitivity.

Globally, the prevalence of type 2 diabetes has reached epidemic proportions, creating a massive demand for safe, effective, and affordable oral antidiabetic agents. As an innovation-driven Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 1000mg Tablets manufacturer in India, Taj Pharma ensures every tablet meets stringent international standards of purity, efficacy, and patient safety.

Taj Pharma’s manufacturing excellence, WHO-GMP certification, and transparent export support have established it as a trusted global supplier of Teneligliptin + Metformin formulations.

Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 1000mg Tablets – Composition, Uses & Benefits

Composition:

• Teneligliptin – 20mg

• Metformin Hydrochloride (Extended Release) – 1000mg

Therapeutic Class: Oral Hypoglycemic Agents (Antidiabetic Medicines)

Uses:

• Management of type 2 diabetes mellitus in adults.

• Helps maintain long-term glycemic control.

• Reduces the risk of diabetes-related complications such as neuropathy, nephropathy, and cardiovascular events.

Key Benefits:

• Dual mechanism for optimal blood sugar control.

• Fewer chances of hypoglycemia and weight gain.

• Sustained release for improved compliance and steady glucose regulation.

• Safe and effective for long-term diabetes management.

Common Side Effects:
Most side effects are mild and transient, including nausea, diarrhea, abdominal bloating, decreased appetite, flatulence, and low blood sugar. They typically subside as the body adjusts to the medicine.

Precaution:
Take Teneligliptin + Metformin (ER) with food to minimize gastrointestinal discomfort. Inform your healthcare provider before undergoing any surgery or anesthesia.

Global Demand for Teneligliptin + Metformin ER Tablets

The global antidiabetic market has seen exponential growth, with a strong shift towards combination therapies. Teneligliptin + Metformin ER 1000mg Tablets are in high demand across Asia, Africa, the Middle East, and Latin America due to their cost-effectiveness and proven efficacy in diabetes management.

Countries with high diabetic populations such as India, Brazil, South Africa, Vietnam, and Nigeria are actively importing fixed-dose combination (FDC) products from reliable manufacturers like Taj Pharma India.

In-Depth Details for Importers/Exporters/Buyers

1. Regulatory Documentation Provided

Taj Pharma provides complete export documentation for Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 1000mg Tablets, ensuring smooth registration and regulatory approval in both regulated and semi-regulated markets.
Key documents include:

• Certificate of Pharmaceutical Product (WHO-COPP)

• Free Sale Certificate (FSC)

• Certificate of Analysis (CoA)

• GMP and ISO Certificates

• CTD/eCTD Dossier (Modules 1–5)

• Stability Data (Zone III & IV)

• Batch Manufacturing Record (BMR)

2. Custom Packaging & Labeling

Taj Pharma offers customizable packaging and private labeling solutions to meet country-specific regulatory and branding requirements.

• Pack Sizes: 10×10 tablets / Blister / Alu-Alu / Bottle packs

• Labeling: Multilingual printing available

• Branding: Private label and custom branding for distributors and PCD franchise owners

3. Shelf-Life, Storage, and Dosage Form

• Dosage Form: Extended Release Tablet

• Shelf Life: 24 to 36 months from manufacturing date

• Storage: Store in a cool, dry place below 30°C, away from moisture and direct sunlight

4. Export Certifications

Taj Pharma’s manufacturing facilities are approved by leading global regulatory authorities. Certifications include:

• WHO-GMP Certified

• ISO 9001:2015 Certified

• EU-GMP Compliance

• COPP & CTD Dossiers Available

• Regulatory Compliance: IP / BP / USP / EP Standards

5. Target Countries & Export Markets

Taj Pharma exports Teneligliptin + Metformin ER Tablets to more than 85 countries, including:
Asia: Vietnam, Philippines, Myanmar, Sri Lanka, Nepal, Bangladesh
Africa: Kenya, Ghana, Ethiopia, Nigeria, Tanzania, South Africa
Middle East: Iraq, Yemen, Jordan, UAE, Saudi Arabia
Latin America: Peru, Bolivia, Chile, Colombia, Guatemala
CIS & Europe: Ukraine, Georgia, Belarus, Armenia

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

1. State-of-the-Art Manufacturing

Taj Pharma operates advanced WHO-GMP-certified facilities in Vapi, Gujarat, equipped with automated manufacturing lines, cleanroom environments, and validated equipment ensuring precision and sterility at every production stage.

2. Stringent Quality Assurance

Each batch of Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 1000mg Tablets undergoes multi-stage quality testing, including:

• Raw material analysis

• In-process quality checks

• Finished product stability & dissolution testing

3. Affordable Pricing & Global Supply Chain

Taj Pharma offers competitive pricing, enabling affordability for government tenders, institutional buyers, and distributors globally. Efficient logistics ensure on-time delivery and customs clearance support.

4. Global Regulatory Expertise

With a dedicated Regulatory Affairs Team, Taj Pharma assists clients with product registration, dossier preparation, and post-approval variations for smooth international compliance.

5. Top 20 Exporting Countries

India, Sri Lanka, Vietnam, Philippines, Kenya, Ethiopia, Nigeria, Peru, Colombia, Myanmar, Ghana, Iraq, Nepal, Chile, UAE, Bolivia, Tanzania, Ukraine, Yemen, and South Africa.

Technical Product Specification

Partner with Taj Pharma Today

Looking for a reliable Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 1000mg Tablets manufacturer in India?

👉 Choose Taj Pharma – your trusted partner for high-quality, cost-effective, and globally certified pharmaceutical formulations.

📞 Contact Details:
Taj Pharma Ltd.
Email: info@tajpharma.com
Website: www.tajpharma.com
Location: Vapi, Gujarat, India

Top 20 FAQs    

1. What is Teneligliptin + Metformin ER used for?
It is used to manage high blood sugar in adults with type 2 diabetes mellitus.

2. Who manufactures this formulation in India?
Taj Pharma Ltd, a WHO-GMP-certified company based in Vapi, Gujarat.

3. How does this combination work?
Teneligliptin enhances insulin secretion; Metformin reduces glucose production.

4. What are the common side effects?
Nausea, diarrhea, flatulence, and mild hypoglycemia.

5. What certifications does Taj Pharma hold?
WHO-GMP, ISO, EU-GMP, and COPP certifications.

6. What is the shelf life?
24–36 months from the date of manufacture.

7. Is it available for PCD Pharma Franchise?
Yes, Taj Pharma offers PCD and third-party manufacturing services.

8. What are the export markets?
Asia, Africa, Middle East, CIS, and Latin America.

9. Is this product available in blister and Alu-Alu packs?
Yes, customizable packaging options are available.

10. Can it be taken without food?
No, it should be taken with food to reduce stomach upset.

11. Does it cause weight gain?
No, chances of weight gain are minimal.

12. Is the product suitable for global registration?
Yes, complete CTD/eCTD dossier and COPP are provided.

13. Can I order private label packaging?
Yes, Taj Pharma offers private labeling options.

14. What are the advantages of the extended-release form?
Ensures steady glucose control and better patient compliance.

15. Is it safe for long-term use?
Yes, when used under medical supervision.

16. What dosage strength is available?
Teneligliptin 20mg + Metformin Hydrochloride (ER) 1000mg.

17. How to store the product?
Store below 30°C, away from moisture.

18. Does Taj Pharma export to Africa?
Yes, major markets include Nigeria, Kenya, and Ghana.

19. How to partner with Taj Pharma?
Contact via email or website for business collaboration.

20. Why choose Taj Pharma?
Trusted quality, WHO-GMP certification, competitive pricing, and timely delivery.

Taj Pharma Ltd has emerged as a global leader in manufacturing Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 1000mg Tablets, ensuring international-quality antidiabetic solutions at affordable prices.  With a strong global presence, regulatory excellence, and unwavering commitment to patient care, Taj Pharma remains the #1 choice for pharmaceutical importers, distributors, and PCD franchise partners worldwide.