Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (5mg+500mg)

Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (5mg+500mg) Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (5mg+500mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (5mg+500mg)
  Each film coated tablet contains:
  Dapagliflozin…………………………………………5mg
  Metformin Hydrochloride IP…………..500mg
  (In extended release form)
  Excipients………………………………………q.s
  Colour: Yellow Oxide of Iron, Red Oxide of
  Iron and Titanium Dioxide IP

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 (5mg+500mg)

Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (5mg+500mg) is a fixed-dose combination medicine widely used to treat type 2 diabetes mellitus. This dual therapy helps control blood sugar levels more effectively than monotherapy and significantly reduces the risk of heart failure, cardiovascular diseases, and hospitalizations in diabetic patients.

Taj Pharma, the well-known Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (5mg+500mg) manufacturer in India, ensures premium quality, high purity, and consistent efficacy in every tablet, complying with international pharmaceutical standards.

Globally, the prevalence of diabetes continues to surge due to urban lifestyles, sedentary habits, and obesity, making effective oral antidiabetic combinations a cornerstone of therapy. As demand for SGLT2 inhibitors like Dapagliflozin grows, this formulation has become highly sought-after in markets across Asia, Africa, the Middle East, and Latin America.

How the Combination Works

This medication combines two powerful agents:

• Dapagliflozin (5mg): A sodium-glucose co-transporter-2 (SGLT2) inhibitor that helps the kidneys remove excess glucose from the body through urine.

• Metformin Hydrochloride (500mg, Extended-Release): A biguanide that decreases glucose production in the liver, delays glucose absorption in the intestines, and enhances insulin sensitivity.

Together, they provide better glycemic control, helping maintain long-term blood sugar stability.

Therapeutic Uses

• Treatment of Type 2 Diabetes Mellitus

• Reduces the risk of heart attack, heart failure, and other cardiovascular events

• Helps in weight management for diabetic patients

• Improves insulin efficiency and glucose tolerance

This combination therapy is particularly useful for patients not adequately controlled with metformin alone.

Dosage and Administration

• Dosage Form: Extended-release tablets

• Recommended Dose: As prescribed by the physician

• Route: Oral, once daily with meals

• Important Instructions:

  • Take at the same time each day for consistent results

  • Maintain proper hydration

  • Continue with diet and exercise as advised by your doctor

Common Side Effects

While generally well-tolerated, some individuals may experience:

• Nasopharyngitis (inflammation of the nose and throat)

• Sore throat or cough

• Urinary tract infections

• Genital fungal infections

• Headache or fatigue

• Nausea, diarrhea, or vomiting

• Nasal congestion and runny nose

Consult your physician if these symptoms persist or worsen.

Precautions and Warnings

• Inform your doctor if you have kidney or liver disease

• Avoid alcohol to reduce the risk of lactic acidosis

• Pregnant or breastfeeding women should consult a healthcare professional before use

• Regular blood glucose monitoring is essential

The Trusted Name in Antidiabetic Formulations

Taj Pharma Ltd., Vapi, Gujarat, stands among the most reputed pharmaceutical manufacturers, offering high-quality Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (5mg+500mg) that meet international regulatory standards.

As a WHO-GMP certified and ISO 9001:2015 compliant company, Taj Pharma is globally recognized for manufacturing excellence, affordability, and reliability.

Key Highlights

• Global exporter of more than 1,000 formulations

• Products comply with IP/BP/USP standards

• Advanced R&D for innovative drug formulations

• Custom manufacturing and private labeling options

In-Depth Information for Importers, Exporters, and Buyers

Taj Pharma offers end-to-end manufacturing and export support to international clients for Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (5mg+500mg).

Regulatory Documentation Provided

• Certificate of Analysis (CoA)

• Drug Master File (DMF)

• Common Technical Document (CTD) Dossier

• Certificate of Pharmaceutical Product (COPP)

• Free Sale Certificate (FSC)

• Stability data and analytical validation reports

Custom Packaging & Labeling

• Blister packs / Alu-Alu / Strip packs

• Multi-language labeling for export markets

• OEM and private-label manufacturing

Shelf Life, Storage, and Dosage Form

• Shelf Life: 24–36 months

• Storage: Store below 30°C, away from moisture and direct sunlight

• Dosage Form: Extended-Release Tablet

Export Certifications

• WHO-GMP

• EU-GMP

• ISO 9001:2015

• COPP

• CTD Dossier

Target Countries & Export Markets

• Asia: India, Nepal, Bangladesh, Sri Lanka, Vietnam

• Africa: Kenya, Nigeria, Ghana, South Africa, Egypt

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

• Europe & Latin America: Portugal, Chile, Peru, Argentina, Mexico

Why is the Most Trusted Manufacturer and Exporter

1. State-of-the-Art Manufacturing

• Advanced infrastructure at Vapi, Gujarat

• Fully automated production lines

• In-house testing and R&D facilities

2. Affordable Pricing & Quality Assurance

• Competitive pricing for global buyers

• Stringent quality control from raw materials to finished product

• Complies with WHO-GMP and EU-GMP guidelines

3. Global Presence & Supply Chain Support

• Strong export network across 40+ countries

• Reliable logistics and on-time deliveries

• Support with regulatory submissions and documentation

4. Top 20 Exporting Countries

UAE || Saudi || Arabia || Oman || Qatar || Kuwait || Nigeria || Kenya || Ghana || South Africa || Egypt || Germany || France || UK || Italy || Spain || Sri Lanka || Myanmar Malaysia || Philippines || Vietnam

Technical Product Specification Table

Call to Action for Distributors and Buyers

Partner with Taj Pharma Ltd., India, a globally trusted Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (5mg+500mg) manufacturer and exporter. Taj Pharma offers unmatched quality, affordability, and global reach for importers, distributors, and PCD franchise partners.

📍 Corporate Office: Taj Pharma India Ltd., Vapi, Gujarat, India
🌐 Website: www.tajpharma.in
📧 Email: info@tajpharma.com
📞 Phone: +91 84484 44095 (Gen. Enq. 01)

Top 20 FAQs 

1. What is this medicine used for?
   It’s used to manage blood sugar levels in type 2 diabetes.

2. Who manufactures it?
   Taj Pharma Ltd., Vapi, Gujarat, India.

3. Is it WHO-GMP certified?
   Yes, Taj Pharma operates under WHO-GMP and ISO 9001:2015 standards.

4. Can it replace insulin?
   No, it complements diet and exercise; insulin may still be required in some cases.

5. How does Dapagliflozin work?
   It helps the kidneys remove excess glucose through urine.

6. How does Metformin work?
   It lowers glucose production in the liver and increases insulin sensitivity.

7. What are the side effects?
   Nausea, diarrhea, UTIs, genital infections, and headache.

8. Can it cause hypoglycemia?
   Rarely, unless taken with other diabetes medicines.

9. Can pregnant women take it?
   Only if prescribed by a healthcare professional.

10. What should I do if I miss a dose?
    Take it as soon as remembered; skip if near the next dose.

11. Is lifestyle modification necessary?
    Yes, exercise and diet play a vital role.

12. How should it be stored?
    Store in a cool, dry place below 30°C.

13. Can it be taken on an empty stomach?
    Best taken with food to minimize stomach upset.

14. Is it safe for elderly patients?
    Yes, with appropriate dosage adjustment.

15. Private labeling available?
    Yes, Taj Pharma offers OEM/private branding.

16. Shelf-life of the product?
    24–36 months under recommended storage conditions.

17. Packaging options?
    Alu-Alu, Blister, or Strip packs.

18. Export markets covered?
    Over 40 countries globally.

19. Documentation support available?
    Yes – CoA, DMF, CTD, COPP, FSC provided.

20. Why choose Taj Pharma?
    WHO-GMP certified, affordable, and globally trusted manufacturer.