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

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

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+1000mg)
  Each film coated tablet contains:
  Dapagliflozin…………………………………………10mg
  Metformin Hydrochloride IP…………………………..1000mg
  (In extended release form)
  Excipients……………………………………………..q.s
  Colour: Titanium Dioxide IP & Ferric
  Oxide Red 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+500mg)

Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+500mg) is a powerful combination medication used to manage Type 2 diabetes mellitus effectively. It combines two well-known antidiabetic agents — Dapagliflozin (a sodium-glucose co-transporter-2 inhibitor) and Metformin (a biguanide).

This dual therapy helps patients control blood sugar levels, reduce insulin resistance, and minimize the risk of complications associated with diabetes. The medication also aids in reducing the risk of hospitalization for heart failure among diabetic patients with cardiovascular diseases or multiple risk factors.

Taj Pharma, a WHO-GMP and ISO-certified pharmaceutical manufacturer in India, produces Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+500mg) with assured purity, safety, and efficacy. The company follows stringent global manufacturing standards to ensure that every batch meets international quality parameters.

Growing Global Demand

The global prevalence of diabetes has led to an exponential demand for combination antidiabetic therapies. As a result, the market for Dapagliflozin and Metformin ER Tablets is growing rapidly across Asia, Africa, Latin America, and Europe. Taj Pharma has established itself as a trusted exporter of this formulation, serving pharmaceutical distributors, hospitals, and PCD franchise partners worldwide.

 In-Depth Details for Importers, Exporters, and Buyers

Taj Pharma provides complete support for international pharmaceutical buyers seeking reliable suppliers of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+500mg).

Regulatory Documentation Provided

Taj Pharma ensures comprehensive documentation support for all export orders, including:

• Certificate of Pharmaceutical Product (COPP)

• WHO-GMP Certificate

• Free Sale Certificate (FSC)

• Certificate of Analysis (CoA)

• Manufacturing License

• Stability Data

• CTD/eCTD Dossier (Module 1–5)

• Bioequivalence Study Data (if required)

These documents ensure that importers meet local drug regulatory authority requirements, facilitating smooth product registration and importation.

Custom Packaging & Labeling

Taj Pharma offers customized packaging and labeling solutions based on the target market’s regulatory needs. Buyers can choose from:

• Blister packs, alu-alu, or strip packaging

• Private label branding under buyer’s logo

• Multilingual artwork support

• Tamper-proof packaging with extended shelf life

Shelf-life, Storage & Dosage Form

• Dosage Form: Film-coated extended-release tablets

• Strength: 10mg Dapagliflozin + 500mg Metformin Hydrochloride

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

• Shelf Life: 24 to 36 months (as per export specifications)

Export Certifications

Taj Pharma is certified by:

• WHO-GMP (World Health Organization – Good Manufacturing Practice)

• ISO 9001:2015

• EU-GMP (European Union GMP)

• GLP (Good Laboratory Practice)

• COPP (Certificate of Pharmaceutical Product)

• CTD Dossier Support for product registration

These global certifications make Taj Pharma a preferred supplier for regulated and semi-regulated markets.

Target Countries & Export Markets

Taj Pharma exports Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+500mg) to over 40+ countries, including:

• Asia: Philippines, Vietnam, Sri Lanka, Nepal, and Myanmar

• Africa: Kenya, Nigeria, Ghana, Tanzania, Ethiopia

• Latin America: Peru, Ecuador, Chile, Bolivia, Guatemala

• CIS & Middle East: Kazakhstan, Uzbekistan, Iraq, Yemen, UAE

• Europe: Poland, Romania, Ukraine

 Why is the Most Trusted Manufacturer, Supplier & Exporter

Taj Pharma India is a leading manufacturer and global exporter of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+500mg) based in Vapi, Gujarat. The company is renowned for its state-of-the-art manufacturing, affordable pricing, and unwavering commitment to quality.

State-of-the-Art Manufacturing

Taj Pharma’s advanced manufacturing unit is WHO-GMP, GLP, and ISO-certified. The facility adheres to cGMP (Current Good Manufacturing Practices) and maintains strict quality control measures across every production stage — from raw material sourcing to final packaging.

Key manufacturing highlights:

• Fully automated manufacturing line

• Dedicated QC and QA laboratories

• Air-controlled environments

• In-house microbiology and analytical testing

Affordable Pricing & Quality Assurance

Taj Pharma ensures competitive pricing without compromising on product quality. Each batch of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+500mg) undergoes rigorous testing to ensure:

• Accurate potency and dosage

• Uniform extended-release performance

• Low impurity levels

• Global pharmacopoeia compliance (USP/BP/EP/IP)

Global Presence & Supply Chain Support

Taj Pharma’s export network spans Asia, Africa, Latin America, and Europe, supported by efficient logistics and documentation teams. The company provides:

• End-to-end shipping support (air/sea freight)

• Cold-chain and ambient shipment management

• Customs clearance documentation

• Prompt after-sales service and tracking

Top 20 Countries Exporting

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

If you are a pharmaceutical distributor, importer, or healthcare organization looking for a reliable manufacturer and exporter of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+500mg), Taj Pharma is your trusted partner.

✅ Contact Details:
Taj Pharmaceuticals Ltd.
Vapi, Gujarat, India
📧 Email: info@tajpharma.com
🌐 Website: www.tajpharma.com

Taj Pharma offers best-in-class formulations, custom export solutions, and timely delivery worldwide — making it the first choice for global buyers.

Top 20 FAQs  

1. What is Dapagliflozin and Metformin Hydrochloride Extended-Release Tablet used for?
It is used to control blood sugar levels in patients with Type 2 diabetes and reduce cardiovascular risk.

2. Who manufactures this medicine in India?
Taj Pharma Ltd., based in Vapi, Gujarat, is a leading WHO-GMP-certified manufacturer.

3. What are the active ingredients?
Each tablet contains Dapagliflozin 10mg and Metformin Hydrochloride 500mg.

4. Is it available for export?
Yes, Taj Pharma exports this medicine to over 40 countries globally.

5. What certifications does Taj Pharma hold?
WHO-GMP, ISO 9001:2015, COPP, and CTD Dossier compliance.

6. How should this medicine be stored?
Store in a cool, dry place below 30°C, away from sunlight.

7. Can Taj Pharma provide private labeling?
Yes, private labeling and custom packaging are available for buyers.

8. What is the shelf life of this product?
Typically 24 to 36 months depending on regulatory requirements.

9. Is it safe for long-term use?
Yes, when used as prescribed under medical supervision.

10. What is the mode of action?
Dapagliflozin removes glucose through urine, and Metformin reduces glucose production in the liver.

11. Are bioequivalence studies available?
Taj Pharma provides BE studies if required by regulatory authorities.

12. What is the export MOQ?
Minimum order quantities are flexible depending on buyer requirements.

13. Is Taj Pharma a WHO-GMP approved facility?
Yes, it operates under WHO-GMP-certified manufacturing standards.

14. Can the product be shipped globally?
Yes, Taj Pharma has export logistics to 40+ countries.

15. Does Taj Pharma provide CTD dossiers?
Yes, full CTD/eCTD dossiers (Modules 1–5) are available.

16. What are common side effects?
Mild side effects include nausea, sore throat, UTI, headache, or diarrhea.

17. Is this product available for PCD Pharma Franchise?
Yes, Taj Pharma offers PCD and franchise opportunities across India.

18. What makes Taj Pharma the best supplier?
Quality assurance, affordability, WHO-GMP compliance, and global reach.

19. Can it be co-administered with insulin?
Only under a physician’s supervision.

20. How to place an export order?
Contact Taj Pharma via email or website with your country’s regulatory requirements.

Taj Pharma stands as a leading manufacturer, supplier, and exporter of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets (10mg+500mg) in India, delivering quality, reliability, and value to global clients. With WHO-GMP certification, advanced manufacturing infrastructure, competitive pricing, and comprehensive regulatory support, Taj Pharma continues to be the top choice for importers and distributors worldwide.