Overview of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets
Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+500mg) are a scientifically advanced formulation used for the management of Type 2 Diabetes Mellitus (T2DM). This fixed-dose combination brings together two powerful antidiabetic agents—Dapagliflozin, an SGLT2 inhibitor, and Metformin Hydrochloride, a biguanide—designed to deliver optimal glycemic control and cardiovascular protection.
Manufactured by Taj Pharma Ltd., India, a WHO-GMP certified pharmaceutical company, this formulation adheres to stringent international quality standards, ensuring safety, efficacy, and consistency for patients worldwide.
Product Information
Product Name: Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets
Brand Name: Generic
Strengths Available: (5mg+500mg), (10mg+500mg), (10mg+1000mg)
Dosage Form: Film-Coated Extended-Release Tablets
Route of Administration: Oral
Packaging: 10×10 tablets per box (Blister/Alu-Alu)
Regulatory Documentation: COA, MOA, Stability Studies, GMP, CTD Dossier, COPP
Therapeutic Class: Antidiabetic
Storage Condition: Store below 30°C, protect from light and moisture
Qualitative and Quantitative Composition
Each film-coated tablet contains:
- Dapagliflozin Propanediol Monohydrate – 10mg
- Metformin Hydrochloride (Extended-Release) – 500mg
- Excipients – q.s.
- Color: Titanium Dioxide IP & Ferric Oxide Yellow USP-NF
This combination ensures sustained drug release, improving patient compliance and maintaining stable plasma glucose levels throughout the day.
Mechanism of Action
Dapagliflozin (SGLT2 Inhibitor):
Dapagliflozin selectively inhibits Sodium-Glucose Co-Transporter 2 (SGLT2) in the proximal renal tubules, reducing glucose reabsorption and promoting urinary glucose excretion. This mechanism helps lower plasma glucose levels independently of insulin secretion.
Metformin Hydrochloride (Biguanide):
Metformin works primarily by suppressing hepatic gluconeogenesis, reducing intestinal glucose absorption, and enhancing peripheral glucose uptake and utilization through improved insulin sensitivity.
Together, these mechanisms provide a synergistic effect, ensuring better glycemic control, weight management, and cardiovascular protection.
Therapeutic Indications
- Management of Type 2 Diabetes Mellitus (T2DM)
- Reduction in the risk of hospitalization for heart failure in patients with diabetes and cardiovascular diseases
- Improvement of insulin sensitivity and glycemic control
- Weight management in obese or overweight diabetic patients
- Reduction of HbA1c levels and long-term diabetes complications
Dosage and Administration
Dosage: As directed by the physician.
Route: Oral
Administration: Tablets should be swallowed whole with water. Do not crush, split, or chew.
Timing: Preferably taken once daily with food to reduce gastrointestinal discomfort.
Caution and Schedule
- CAUTION: Read enclosed leaflet before use.
- Schedule G Prescription Drug:
“It is dangerous to take this preparation except under medical supervision.” - Keep out of reach of children.
- Not to be sold without prescription of a registered medical practitioner.
Storage and Stability
- Storage Temperature: Below 30°C
- Conditions: Store in a cool, dry, and dark place
- Protection: Protect from light and moisture
- Shelf Life: 24–36 months under recommended conditions
Clinical Benefits and Key Advantages
- Effective Glycemic Control: Maintains fasting and postprandial glucose levels.
- Cardiovascular Protection: Reduces risk of heart failure-related hospitalization.
- Weight Reduction: Promotes calorie loss through urinary glucose excretion.
- Improved Insulin Sensitivity: Enhances cellular glucose uptake.
- Lipid Profile Improvement: Contributes to better cholesterol balance.
- Once-Daily Dosing: Enhances patient adherence and convenience.
Global Market Demand and Supply
The global antidiabetic market has experienced exponential growth due to the increasing prevalence of diabetes and lifestyle-related disorders. Dapagliflozin and Metformin combinations are highly preferred due to their dual mechanism and long-term safety profile.
Taj Pharma Ltd. is among the most trusted manufacturers, suppliers, and exporters of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, catering to over 75+ countries across Asia, Africa, the Middle East, Latin America, and CIS regions.
Top Export Markets Include:
Nigeria, Kenya, Ghana, Tanzania, Vietnam, Myanmar, Cambodia, Sri Lanka, UAE, Iraq, Yemen, Uzbekistan, Nepal, Sudan, Ethiopia, Cameroon, Peru, and Bolivia.
Regulatory & Export Compliance
Taj Pharma ensures comprehensive regulatory support for product registration and international trade. The company provides globally accepted technical documentation for smooth market entry.
Documentation Provided:
- Certificate of Pharmaceutical Product (COPP)
- Certificate of Analysis (COA)
- Drug Master File (DMF)
- Stability & Bioequivalence Data
- GMP Certificates
- Batch Manufacturing Records (BMR)
- Free Sale Certificate (FSC)
- CTD/ACTD Dossier
Packaging & Labeling Options:
- Export-grade Blister/Alu-Alu packs
- Multilingual labeling
- Customizable branding for private/contract manufacturing
- Tamper-proof sealing and moisture-resistant films
Manufacturing Excellence at Taj Pharma
1. WHO-GMP Certified Facilities
Taj Pharma’s ultra-modern manufacturing units in Vapi, Gujarat, comply with WHO-GMP, ISO 9001:2015, and select EU-GMP certifications. Each batch undergoes strict quality control and microbiological testing to ensure global standards of excellence.
2. Quality Assurance and Compliance
All production follows cGMP, GLP, and pharmacopeial standards (IP/BP/USP). Every product passes through multiple quality checkpoints, ensuring purity, potency, and stability.
3. Competitive Pricing and Accessibility
Taj Pharma offers cost-effective pharmaceutical solutions without compromising quality, ensuring affordability for importers and healthcare systems worldwide.
4. Expertise in Global Exports
With a robust distribution network, Taj Pharma maintains reliable logistics and cold-chain management for sensitive formulations, guaranteeing on-time delivery and product integrity.
Technical Product Specification
| Parameter | Details |
|---|---|
| Product Name | Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets |
| Strength | 10mg + 500mg |
| Dosage Form | Extended-Release Film-Coated Tablets |
| Pharmacopoeia | IP / BP / USP |
| Packaging | 10×10 Tablets per Box |
| Storage | Below 30°C, protect from moisture and light |
| Shelf Life | 24–36 months |
| Manufacturer | Taj Pharma Ltd., Vapi, Gujarat, India |
| Certifications | WHO-GMP, ISO 9001:2015, COPP, CTD Dossier |
Why Choose Taj Pharma
- Global leader in antidiabetic formulation manufacturing
- WHO-GMP, ISO, and COPP certified production facilities
- Expertise in regulatory documentation and product registration
- Strong R&D base ensuring innovative and stable formulations
- Flexible third-party and contract manufacturing options
- Commitment to ethical business practices and sustainability
Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+500mg) from Taj Pharma Ltd. represent a clinically proven, globally trusted formulation for the management of Type 2 Diabetes Mellitus. With cutting-edge manufacturing technology, strong regulatory compliance, and export excellence, Taj Pharma continues to lead the way in delivering affordable and high-quality diabetic care solutions worldwide.
For inquiries, partnerships, or bulk orders:
📧 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com
📞 Phone: +91 84484 44095