Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 500mg Tablets

Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 500mg Tablets Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 500mg Tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 500mg Tablets
  Each uncoated bilayered tablet contains:
  Teneligliptin Hydrochloride Hydrate
  Equivalent to Teneligliptin……………….20mg
  Metformin Hydrochloride IP…………….500mg
  (As Extended Release)
  Excipients………………………………………q.s
  Colours: Ferric oxide Yellow USP-NF
  (Yellow 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: Understanding Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 500mg Tablets

Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 500mg Tablets are a widely prescribed combination medication for the management of type 2 diabetes mellitus. The tablet blends the therapeutic power of Teneligliptin, a DPP-4 inhibitor, and Metformin Hydrochloride, a biguanide, offering superior blood glucose control when diet and exercise alone are insufficient.

Globally, diabetes management is a major public health priority, and the demand for effective, affordable, and high-quality antidiabetic drugs continues to rise. In this scenario, Taj Pharma Ltd, one of India’s most reputed pharmaceutical companies, stands out as a trusted manufacturer, exporter, and supplier of Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 500mg Tablets.

Taj Pharma the well-known Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 500mg Tablets manufacturer in India gives the assurance of high-quality, efficacy, and purity. This medication is used to manage high blood sugar levels in adults with type 2 diabetes mellitus, helping prevent complications such as heart disease, kidney failure, and nerve damage.

What Makes Teneligliptin + Metformin a Powerful Combination for Type 2 Diabetes

1. Teneligliptin 20mg

Teneligliptin belongs to the class of Dipeptidyl Peptidase-4 (DPP-4) inhibitors. It works by increasing the levels of incretin hormones, which help regulate insulin and glucagon secretion, thereby lowering blood glucose levels.

2. Metformin Hydrochloride (Extended Release) 500mg

Metformin is a first-line therapy for type 2 diabetes. It works by reducing hepatic glucose production and enhancing insulin sensitivity, resulting in improved glucose uptake by muscles. The extended-release formulation provides sustained control of blood sugar throughout the day.

Together, these two active ingredients deliver synergistic benefits:

• Lower fasting and postprandial glucose levels.

• Reduce HbA1c effectively.

• Minimize risks of hypoglycemia compared to sulfonylureas.

• Promote better patient compliance due to once-daily dosing.

Global Demand and Market Outlook

The global diabetes therapeutics market is projected to surpass USD 85 billion by 2030, with a significant share attributed to combination oral antidiabetic drugs. Emerging markets in Asia, Africa, the Middle East, and Latin America are driving demand due to rising diabetes prevalence and growing access to affordable healthcare.

India, being the pharmacy of the world, plays a crucial role in supplying WHO-GMP-certified generic formulations of essential antidiabetic medications. Taj Pharma, with its strong regulatory compliance and export excellence, is positioned as a leading Teneligliptin + Metformin manufacturer in India, catering to both domestic and international buyers.

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

Taj Pharma offers comprehensive support to importers, distributors, and PCD franchise partners, ensuring smooth regulatory and commercial operations.

Regulatory Documentation Provided

Taj Pharma provides complete export and registration support, including:

• WHO-GMP Certificate

• EU-GMP compliance

• Certificate of Pharmaceutical Product (COPP)

• CTD / ACTD dossiers

• Stability data (Zone I–IV)

• Free Sale Certificate

• Certificate of Analysis (COA)

• MSDS and Batch Manufacturing Record

Custom Packaging & Labelling

Taj Pharma offers customized packaging solutions to meet international regulatory and branding needs:

• Alu-Alu / Blister packs

• Boxed packs with multilingual labels

• Tamper-proof secondary packaging

• Compliance with import country labelling norms

Shelf-Life and Storage

• Shelf Life: 24–36 months from manufacturing date

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

Dosage Form

• Film-coated, Extended Release tablets

• Strength: Teneligliptin 20mg + Metformin Hydrochloride (ER) 500mg

Export Certifications

Taj Pharma holds a wide range of international certifications:

• WHO-GMP approved plant (Vapi, Gujarat)

• ISO 9001:2015 certified

• EU-GMP compliant manufacturing units

• COPP and CTD dossiers for global registration

Target Export Markets

Taj Pharma exports Teneligliptin 20mg + Metformin Hydrochloride (ER) 500mg Tablets to over 40 countries, including:

Nigeria || Kenya || Ghana || Uganda || South Africa || UAE || Saudi Arabia || Oman || Qatar|| Kuwait || Russia || Kazakhstan || Uzbekistan || Kyrgyzstan || Vietnam || Philippines || Myanmar || Sri Lanka || Peru || Chile ||

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 ultra-modern WHO-GMP and EU-GMP certified facilities with automated production lines, advanced granulation, and coating equipment. The company adheres to stringent quality assurance protocols in every stage — from raw material procurement to final packaging.

2. Affordable Pricing & Quality Assurance

Taj Pharma ensures cost-effective pricing while maintaining international quality standards, making its products accessible globally. The company follows ICH, PIC/S, and WHO guidelines, with rigorous analytical testing.

3. Global Presence & Supply Chain Efficiency

With a strong global footprint across Asia, Africa, Latin America, and CIS countries, Taj Pharma ensures timely deliveries through a robust logistics network. Export partners receive full regulatory and marketing support.

4. Top 20 Countries Exporting

Taj Pharma’s export presence spans across:
India, Kenya, Uganda, Vietnam, Sri Lanka, Myanmar, Nepal, Cambodia, Ghana, Nigeria, Tanzania, Yemen, Peru, Philippines, Afghanistan, Mozambique, Iraq, UAE, Sudan, and South Africa.

Technical Product Specification Table

Call to Action for Buyers and Distributors

If you are a global importer, distributor, or PCD franchise partner seeking a trusted supplier of Teneligliptin 20mg + Metformin Hydrochloride (Extended Release) 500mg Tablets, Taj Pharma Ltd is your ideal manufacturing partner.

✅ Contact Taj Pharma Today:
Email: info@tajpharma.com
Website: www.tajpharma.com
Head Office: Taj Pharma India Ltd., Vapi, Gujarat, India

Partner with a WHO-GMP certified manufacturer that delivers global-standard formulations at competitive pricing with unmatched reliability.

Top 20 FAQs 

1. What is Teneligliptin + Metformin Hydrochloride used for?
It’s prescribed to manage type 2 diabetes mellitus by controlling high blood sugar levels.

2. How should I take this medication?
It should be taken once daily with food to minimize gastrointestinal discomfort.

3. What are the common side effects?
Common effects include nausea, diarrhea, bloating, and mild hypoglycemia.

4. Can it cause weight gain?
This combination is weight neutral, unlike many other diabetes medications.

5. Is it safe for long-term use?
Yes, when prescribed and monitored by a doctor, it can be safely used long-term.

6. Can I take alcohol with this medicine?
Avoid alcohol as it may increase the risk of lactic acidosis and hypoglycemia.

7. How should I store it?
Store at below 30°C, away from heat and moisture.

8. Is Taj Pharma WHO-GMP certified?
Yes, Taj Pharma’s Vapi facility is WHO-GMP and ISO 9001:2015 certified.

9. What documents are required for export registration?
COPP, CTD dossier, COA, Stability Data, and Batch Manufacturing Records are provided.

10. Do you offer custom branding and private labeling?
Yes, Taj Pharma supports private label and OEM manufacturing for international buyers.

11. What is the shelf life of this product?
Typically 24 to 36 months under recommended storage conditions.

12. Is it available in ER formulation?
Yes, this is the Extended Release (ER) version for once-daily dosage.

13. Can it be shipped internationally?
Yes, Taj Pharma exports to 40+ countries across continents.

14. What is the minimum order quantity (MOQ)?
MOQ varies per market, typically 1–2 lakh tablets for export orders.

15. Is a CTD dossier available for registration?
Yes, a comprehensive CTD dossier is available for all import markets.

16. What’s the HS Code for export?
HS Code: 30049099 – Medicaments containing other active principles.

17. Can I get a free product sample?
Yes, samples can be arranged upon regulatory and import clearance.

18. Do you provide marketing support for PCD franchise partners?
Yes, Taj Pharma provides visual aids, MR literature, and marketing support.

19. How is the packaging designed for exports?
Tamper-proof, moisture-resistant, and compliant with export country regulations.

20. Why should I choose Taj Pharma?
Because Taj Pharma offers trusted quality, affordability, and regulatory reliability as a leading WHO-GMP-certified manufacturer in India.