Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+500mg)

Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+500mg) Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+500mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+500mg)
  Each film coated tablet contains:
  Dapagliflozin…………………………………………10mg
  Metformin Hydrochloride IP…………………………..500mg
  (In extended release form)
  Excipients……………………………………………..q.s
  Colour: Titanium Dioxide IP & Ferric
  Oxide Yellow USP-NF

THERAPEUTIC INDICATIONS:

Dapagliflozin and metformin combination is used together with proper diet and exercise to treat type 2 diabetes. It is also used to lower the risk of hospitalization for heart failure in patients with type 2 diabetes and cardiovascular (heart or blood vessel) disease or multiple cardiovascular risk factors.

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.

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 Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+1000mg)

Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+1000mg) are a fixed-dose combination of two well-known antidiabetic agents designed to effectively manage Type 2 Diabetes Mellitus (T2DM). This powerful combination works synergistically to maintain healthy blood sugar levels while reducing the risk of diabetes-related cardiovascular complications.

Taj Pharma, the leading Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+1000mg) manufacturer in India, ensures the highest standards of quality and purity in every batch. The medicine is used together with diet and exercise to control blood glucose levels and to lower the risk of heart failure hospitalizations in diabetic patients with existing cardiovascular disease or risk factors.

The product has witnessed global demand, especially in markets such as Africa, Latin America, Southeast Asia, and CIS countries, due to its proven efficacy, safety profile, and Taj Pharma’s adherence to stringent international quality norms.

Composition and Mechanism of Action

Each film-coated extended-release tablet contains:

• Dapagliflozin Propanediol Monohydrate – 10mg

• Metformin Hydrochloride (Extended-Release) – 1000mg

Mechanism:

• Dapagliflozin belongs to the class of Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitors, promoting the elimination of excess glucose through urine.

• Metformin, a biguanide, reduces hepatic glucose production, improves peripheral glucose uptake, and enhances insulin sensitivity.

Together, they deliver superior glycemic control, reduce body weight, and lower cardiovascular risk.

Therapeutic Uses and Benefits

• Management of Type 2 Diabetes Mellitus (T2DM)

• Reduction in hospitalization risk due to heart failure

• Improvement of insulin sensitivity

• Supports weight management in diabetic patients

• Lowers HbA1c effectively compared to monotherapy

• Enhances overall cardiovascular health

Global Demand and Market Overview

The global antidiabetic drug market has seen exponential growth, with combination therapies like Dapagliflozin and Metformin gaining prominence. The increasing prevalence of diabetes, sedentary lifestyles, and growing awareness about preventive healthcare have boosted the market.

Countries across Asia, the Middle East, Africa, and Latin America actively import from Indian manufacturers due to the cost-effective pricing, WHO-GMP quality standards, and reliable supply chain offered by companies like Taj Pharma.

Regulatory & Export Compliance for Global Buyers

As a WHO-GMP and EU-GMP certified manufacturer, Taj Pharma provides comprehensive regulatory and technical documentation to ensure smooth registration and importation processes for global buyers.

Documentation Provided:

• Certificate of Pharmaceutical Product (COPP)

• Drug Master File (DMF)

• Common Technical Document (CTD Dossier)

• Certificate of Analysis (COA)

• Stability Data & Bioequivalence Reports

• GMP and Manufacturing Licenses

• Free Sale Certificate (FSC)

• Batch Manufacturing Records (BMR)

Packaging & Labeling:

• Customizable blister or strip packs

• Export-grade packaging materials

• Multilingual labeling for regulatory compliance

• Tamper-proof sealing for export shipments

Dosage Form & Storage:

• Dosage Form: Extended-Release Film-Coated Tablet

• Shelf Life: 24 to 36 months

• Storage: Store below 30°C, protect from moisture and light

Taj Pharma offers flexible branding and private labeling options for global partners under contract manufacturing or third-party manufacturing agreements.

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

1. WHO-GMP Certified State-of-the-Art Facilities

Taj Pharma operates from Vapi, Gujarat, maintaining WHO-GMP, ISO 9001:2015, and EU-GMP certified production facilities. Every product undergoes multi-level quality assurance to ensure purity, potency, and safety.

2. Strict Quality Assurance & Regulatory Compliance

From raw material procurement to finished product testing, Taj Pharma implements cGMP and GLP practices, adhering to international pharmacopeial standards such as USP, BP, and IP.

3. Affordable Pricing with Global Reach

Taj Pharma’s competitive pricing strategy ensures accessibility for global importers while maintaining uncompromised quality—making it the most preferred exporter of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+1000mg) in India.

4. Expertise in Global Export

With an established distribution network in over 75+ countries, Taj Pharma is a pioneer in pharmaceutical exports to regulated and semi-regulated markets.

Top 20 Export Markets Include:
Afghanistan, Nigeria, Kenya, Vietnam, Cambodia, Myanmar, Philippines, Sri Lanka, UAE, Yemen, Iraq, Ghana, Tanzania, Uzbekistan, Nepal, Sudan, Ethiopia, Cameroon, Peru, and Bolivia.

5. Strong Supply Chain & Timely Delivery

Advanced logistics and partnerships with global shipping providers ensure on-time delivery and temperature-controlled transport for sensitive formulations.

Technical Product Specification

Why Global Buyers Choose Taj Pharma

• Comprehensive regulatory support for quick product registration.

• Customized manufacturing as per buyer specifications.

• Sustainable sourcing and eco-friendly production.

• Transparent business practices and ethical dealings.

• Proven expertise in antidiabetic formulations.

Whether you’re an importer, distributor, or PCD franchise partner, Taj Pharma ensures consistent quality, reliable documentation, and prompt service.

Are you searching for a reliable Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+1000mg) manufacturer in India?
Join hands with Taj Pharma Ltd, a globally trusted pharmaceutical manufacturer and exporter from Vapi, Gujarat.

👉 Contact Today:
📧 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com
📞 Phone: +91 84484 44095 (Gen. Enq. 01)

Partner with Taj Pharma for premium quality formulations, competitive pricing, and global export support.

Top 20 FAQs  

1. What are Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets used for?
They help control blood sugar levels in patients with type 2 diabetes and lower the risk of heart failure hospitalization.

2. What class of drugs do they belong to?
Dapagliflozin is an SGLT2 inhibitor; Metformin is a biguanide.

3. What is the dosage strength offered by Taj Pharma?
10mg Dapagliflozin + 1000mg Metformin (Extended-Release).

4. Are these tablets WHO-GMP certified?
Yes, Taj Pharma manufactures under WHO-GMP and ISO-certified facilities.

5. Can global importers register this product easily?
Yes, Taj Pharma provides CTD dossiers, COPP, and all necessary documentation.

6. How should these tablets be stored?
Below 30°C, in a dry and dark place.

7. Are these tablets safe during pregnancy?
Consult a physician; they are generally not recommended during pregnancy.

8. What is the shelf life of the product?
Typically 24 to 36 months under proper storage.

9. Can these be branded for export markets?
Yes, private labeling and branding are available for partners.

10. Does Taj Pharma offer third-party manufacturing?
Yes, Taj Pharma specializes in third-party and contract manufacturing.

11. What are common side effects?
Nausea, diarrhea, urinary tract infections, and genital infections.

12. What packaging options are available?
Blister packs or Alu-Alu packaging as per client requirements.

13. What are the regulatory markets served by Taj Pharma?
Asia, Africa, Middle East, and Latin America.

14. What certifications does Taj Pharma hold?
WHO-GMP, EU-GMP (select lines), ISO, COPP.

15. What is the recommended administration method?
Oral, once daily with food or as prescribed by a physician.

16. Can it be combined with other diabetes medicines?
Yes, under medical supervision.

17. What is Taj Pharma’s production capacity?
Over 1 billion tablets annually across various formulations.

18. Is stability data available?
Yes, real-time and accelerated stability data are provided.

19. How to place an export order?
Contact Taj Pharma’s export division via email or phone.

20. Why choose Taj Pharma over competitors?
Because Taj Pharma combines affordability, WHO-GMP quality, global export expertise, and exceptional customer service.

Taj Pharma Ltd stands as the 1 Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+1000mg) manufacturer in India, setting global benchmarks in quality, compliance, and innovation. The company’s unwavering dedication to patient safety, affordability, and international regulatory excellence makes it the preferred partner for global pharmaceutical buyers, importers, and distributors.