Dapagliflozin Tablet 5mg

Dapagliflozin Tablet 5mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Dapagliflozin Tablet 5mg
• Dapagliflozin Tablet 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• a) Dapagliflozin Tablet 5mg
  Each filmed coated Tablet contains:
  Dapagliflozin propanediol monohydrate
  Equivalent to Dapagliflozin…………………………5mg
  Excipients……………………………………………………q.s.
  Colours: Iron oxide Yellow ph.Eur
• b) Dapagliflozin Tablet 10mg
  Each filmed coated Tablet contains:
  Dapagliflozin propanediol monohydrate
  Equivalent to Dapagliflozin…………………………10mg
  Excipients……………………………………………………q.s.
  Colours: Quinoline Yellow

CAUTION & WARNING:

• CAUTION:
  Read enclosed leaflet before use.
  Keep medicine out of reach of children.
  SWALLOW WHOLE DO NOT CHEW OR CRUSH
• Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

• Storage: Protect form moisture at a temperature not exceeding 25˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
• Dosage: As directed by the Physician.

Introduction to Dapagliflozin Tablet 5mg

Dapagliflozin Tablet 5mg is an advanced oral antidiabetic medication used in the management of Type 2 Diabetes Mellitus. It belongs to the class of SGLT2 inhibitors and works in the kidneys to block glucose reabsorption, thereby lowering blood sugar levels.

This medicine is widely prescribed alone or in combination with other antidiabetic agents. It not only helps in glycemic control but also reduces the risk of cardiovascular events and supports weight management.

Globally, the demand for Dapagliflozin Tablet 5mg is rising sharply due to the increasing prevalence of Type 2 Diabetes and the shift towards modern, effective, and convenient oral therapies. This makes India’s role as a pharmaceutical manufacturing hub crucial for international buyers and importers.

Global Demand & Market Potential

The worldwide Type 2 Diabetes market is projected to grow at over 8% CAGR in the coming years, with Dapagliflozin being one of the top-selling molecules. Countries in Asia-Pacific, Middle East, Africa, and Latin America are witnessing the fastest adoption, driven by:

• Growing diabetic population

• Affordable generic alternatives

• International clinical approvals and guidelines recommending SGLT2 inhibitors

This trend makes India, and specifically Taj Pharma, a strategic partner for bulk manufacturing and global distribution of Dapagliflozin Tablet 5mg.

In-Depth Details for Importers, Exporters & Global Buyers

Regulatory Documentation Provided

Taj Pharma offers complete regulatory support, including:

• WHO-GMP Certificate

• EU-GMP (where applicable)

• Certificate of Pharmaceutical Product (COPP)

• CTD / ACTD Dossier for registration

• Stability Data (Zone IV conditions)

• Free Sale Certificate

• Manufacturing License & COA

Custom Packaging & Labeling

• Private Label / OEM options available

• Multilingual packaging as per importing country’s regulatory norms

• Tamper-proof blister/aluminum/aluminium-alu packs

• Custom color, branding, and serialization

Shelf-life & Storage

• Shelf-life: 24 to 36 months from manufacturing date

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

Dosage Form & Administration

• Strength: 5mg

• Dosage Form: Film-coated tablet

• Route: Oral

• Administration: Once daily, with or without food, at the same time each day

Export Certifications

• WHO-GMP

• EU-GMP (if required)

• ISO 9001:2015

• COPP (Country-specific)

• Halal Certification (where applicable)

Target Countries & Export Markets

Taj Pharma exports Dapagliflozin Tablet 5mg to more than 20 countries, including:
UAE, Saudi Arabia, Iraq, Kenya, Nigeria, South Africa, Vietnam, Myanmar, Sri Lanka, Nepal, Cambodia, Peru, Chile, Ecuador, Dominican Republic, Philippines, Yemen, Sudan, Afghanistan, and CIS nations.

Why is the Most Trusted Manufacturer, Supplier & Exporter

1. State-of-the-Art Manufacturing

Taj Pharma’s WHO-GMP & ISO-certified facility in Vapi, Gujarat is equipped with advanced tablet compression, coating, and blistering lines ensuring uniformity, stability, and bioequivalence of every batch.

2. Affordable Pricing with Quality Assurance

Despite competitive global pricing, Taj Pharma never compromises on quality. Each batch undergoes rigorous QC and QA checks for assay, dissolution, microbial limit, and stability.

3. Global Presence & Supply Chain Strength

With PAN India distribution and export supply chains covering Africa, Asia, CIS, and LATAM, Taj Pharma ensures on-time delivery with compliant logistics and cold-chain options if needed.

4. Top 20 Countries Exporting Dapagliflozin Tablet 5mg

Nigeria, Kenya, South Africa, Vietnam, Philippines, Iraq, Libya, Uzbekistan, Ghana, Ethiopia, Yemen, Tanzania, Sri Lanka, Afghanistan, Myanmar, Nepal, Kazakhstan, Ecuador, Bangladesh, Dominican Republic

Technical Product Specification Table

📞 Contact Taj Pharma today for export pricing, registration support, and bulk supply contracts.
🌐 Visit: www.tajpharma.com
✉️ Email: info@tajpharma.com

Top 20 FAQs

1. What is Dapagliflozin Tablet 5mg used for?
It’s used for managing Type 2 Diabetes by lowering blood sugar through increased glucose excretion in urine.

2. Is it safe for long-term use?
Yes, when prescribed by a doctor and monitored regularly.

3. Can it be taken with metformin?
Yes, it is often used in combination with metformin for better control.

4. Should it be taken with food?
It can be taken with or without food.

5. Are there any side effects?
Common side effects include urinary tract infections, thirst, and genital fungal infections.

6. Is Dapagliflozin Tablet 5mg suitable for Type 1 Diabetes?
No, it is approved only for Type 2 Diabetes.

7. Can pregnant women take it?
Only if prescribed; generally avoided during pregnancy.

8. Does it cause weight loss?
Yes, mild weight loss may occur as it eliminates glucose from the body.

9. Is Taj Pharma WHO-GMP certified?
Yes, Taj Pharma meets WHO-GMP and ISO standards.

10. Can I get it in my brand name?
Yes, Taj Pharma offers private labeling and OEM services.

11. What is the shelf life?
Typically 24 to 36 months.

12. How is it shipped internationally?
By air or sea with full export compliance.

13. What packaging options are available?
10×10 blisters, alu-alu, or custom packs.

14. Does it require a prescription?
Yes, it is a prescription-only medicine.

15. Can I store it in the fridge?
Not required; store at room temperature below 30°C.

16. Does Taj Pharma supply to government tenders?
Yes, globally.

17. Is it available in PAN India?
Yes, with nationwide distribution.

18. How fast is delivery for exports?
Generally within 3-4 weeks after order confirmation.

19. Does Taj Pharma assist with product registration?
Yes, full dossier and regulatory support is provided.

20. Why choose Taj Pharma for Dapagliflozin?
For WHO-GMP quality, competitive pricing, and proven export track record.