Dapagliflozin, Sitagliptin & Metformin Hydrochloride Extended Release Tablets

Dapagliflozin, Sitagliptin & Metformin Hydrochloride Extended Release Tablets (10+100+500 mg) Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Dapagliflozin, Sitagliptin & Metformin Hydrochloride Extended Release Tablets (10+100+500 mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Each film coated tablet contains:
   Dapagliflozin Propanediol Monohydrate
   to  Dapagliflozin                                 10 mg
   Sitagliptin Phosphate Monohydrate I.P.
   to Sitagliptin                                      100 mg
   Metformin Hydrochloride I.P.
   (as an extended release form)           500 mg
   Excipients                                               q.s.
   Colours: Ferric oxide yellow USP-NF & Titanium dioxide I.P.

THERAPEUTIC INDICATIONS:

improve glycemic control in adults with type 2 diabetes mellitus. This formulation treats patients whose blood sugar is not adequately managed by individual components.

CAUTION & SCHEDULE:

CAUTION:  preventing severe dehydration, managing hypoglycemia (low blood sugar), and monitoring for rare risks like lactic acidosis, acute kidney damage, genital infections, or pancreatitis, requiring strict adherence to medical guidance.

SCHEDULE: SCHEDULE H:  Not to be sold by retail without the prescription of a Registered medical practitioner.

STORAGE & DOSAGE:

Storage: Store protected from light & moisture

Dosage: As prescribed by the Physician or refer enclosed pack insert.

Dapagliflozin, Sitagliptin & Metformin Hydrochloride Extended Release Tablets (10+100+500 mg) Manufacturer in India

India has emerged as a global pharmaceutical powerhouse, supplying high-quality medicines across continents. Among the most in-demand antidiabetic formulations is Dapagliflozin, Sitagliptin & Metformin Hydrochloride Extended Release Tablets (10+100+500 mg)—a powerful triple-drug combination designed to manage type 2 diabetes effectively.

Taj Pharma, a reputed pharmaceutical company based in Vapi, Gujarat, stands as a leading Dapagliflozin, Sitagliptin & Metformin Hydrochloride Extended Release Tablets (10+100+500 mg) Manufacturer in India, offering unmatched quality, compliance, and global export support.

 Introduction to Dapagliflozin, Sitagliptin & Metformin Hydrochloride Extended Release Tablets (10+100+500 mg)

Dapagliflozin, Sitagliptin & Metformin Hydrochloride Extended Release Tablets (10+100+500 mg) is a combination of three advanced antidiabetic medicines that work synergistically to control blood sugar levels in patients with type 2 diabetes.

• Dapagliflozin increases urinary glucose excretion, reducing blood sugar.
• Metformin Hydrochloride (Extended Release) decreases glucose production in the liver and improves insulin sensitivity.
• Sitagliptin enhances incretin hormones, boosting insulin release and reducing excess glucose production.

This triple-action formula is widely prescribed due to its improved glycemic control, reduced cardiovascular risks, and patient compliance benefits.

Global Demand

With the increasing prevalence of diabetes worldwide, especially in regions like Africa, Southeast Asia, Latin America, and the Middle East, the demand for this combination therapy is rapidly growing. Importers and healthcare providers seek reliable Dapagliflozin, Sitagliptin & Metformin Hydrochloride Extended Release Tablets (10+100+500 mg) suppliers to ensure consistent supply and quality.

 Safety, Usage & Medical Guidance

Taj Pharma, the well-known Dapagliflozin, Sitagliptin & Metformin Hydrochloride Extended Release Tablets (10+100+500 mg) manufacturer in India, ensures high purity and quality standards. However, proper medical supervision is essential.

Important Safety Considerations

• Prevent severe dehydration by maintaining adequate hydration.
• Monitor for hypoglycemia (low blood sugar), especially when combined with other antidiabetics or alcohol.
• Be aware of rare but serious risks:
  • Lactic acidosis
  • Acute kidney injury
  • Pancreatitis
  • Genital infections

Common Side Effects

• Diarrhea, nausea, vomiting
• Flatulence
• Polyuria (frequent urination)
• Dyslipidemia
• Urinary tract infection
• Nasopharyngitis
• Headache, cough, conjunctivitis

Patients should regularly monitor blood glucose and kidney function under medical guidance.

 In-Depth Details for Importers, Exporters & Buyers

Regulatory Documentation Provided

Taj Pharma offers complete documentation support for global buyers:

• Certificate of Pharmaceutical Product (COPP)
• CTD/ACTD Dossier
• Stability Data
• Bioequivalence Data (if required)
• MSDS (Material Safety Data Sheet)

Custom Packaging & Labeling

• Blister packs / Alu-Alu / HDPE bottles
• Private labeling options
• Multilingual packaging as per importing country norms

Shelf-Life, Storage & Dosage Form

• Dosage Form: Extended Release Tablets
• Strength: 10 mg + 100 mg + 500 mg
• Shelf Life: 24–36 months
• Storage: Store below 25°C, protect from moisture and light

Export Certifications

Taj Pharma is a WHO-GMP manufacturer in India and provides:

• WHO-GMP Certification
• EU-GMP Compliance (where applicable)
• ISO Certifications
• FDA-compliant facilities
• COPP for international registration

Target Countries & Export Markets

Taj Pharma exports to over 50+ countries, including:

• Africa (Nigeria, Kenya, Ghana, South Africa)
• Southeast Asia (Philippines, Vietnam, Myanmar)
• Middle East (UAE, Saudi Arabia, Yemen)
• Latin America (Peru, Chile, Guatemala)
• CIS Countries (Uzbekistan, Kazakhstan)

  Why Taj Pharma is the Most Trusted Manufacturer & Exporter

State-of-the-Art Manufacturing

Taj Pharma operates advanced manufacturing facilities in Vapi, Gujarat, adhering to international quality standards. The production units are equipped with:

• Automated production lines
• Stringent quality control labs
• Advanced R&D infrastructure

Affordable Pricing & Quality Assurance

As a top Dapagliflozin, Sitagliptin & Metformin Hydrochloride Extended Release Tablets (10+100+500 mg) supplier, Taj Pharma offers:

• Competitive pricing for bulk orders
• Consistent batch-to-batch quality
• Stringent QA/QC processes

Global Presence & Supply Chain Support

• Timely delivery across continents
• Strong logistics partnerships
• Efficient export documentation handling

Top 20 Countries Exporting

India, USA, UK, Germany, France, Italy, Spain, UAE, Saudi Arabia, Nigeria, Kenya, South Africa, Vietnam, Philippines, Myanmar, Peru, Chile, Uzbekistan, Kazakhstan, Australia.

 Technical Product Specification Table

  PAN India Manufacturer & Supplier Network

Taj Pharma is a leading:

• Dapagliflozin, Sitagliptin & Metformin Hydrochloride Extended Release Tablets (10+100+500 mg) Manufacturer in Mumbai
• Manufacturer & Supplier in Vapi, Gujarat
• PAN India Supplier & Exporter
• PCD Pharma Franchise Provider

The company offers excellent opportunities for distributors and franchise partners across India and international markets.

  Call to Action for Buyers & Distributors

If you are looking for a reliable Dapagliflozin, Sitagliptin & Metformin Hydrochloride Extended Release Tablets (10+100+500 mg) supplier, Taj Pharma is your trusted partner.

Why Choose Taj Pharma?

• WHO-GMP certified manufacturing
• Global export expertise
• Competitive bulk pricing
• Custom branding solutions

📩 Contact Taj Pharma today to request:

• Product samples
• Quotation
• Dossier documents
• Distribution partnerships

  Top 20 FAQs  

1. What is this medicine used for?

It is used to manage type 2 diabetes by controlling blood sugar levels.

2. How does this combination work?

It combines three mechanisms: glucose excretion, insulin enhancement, and reduced glucose production.

3. Who is the best manufacturer in India?

Taj Pharma is a leading manufacturer and exporter.

4. Is it safe for long-term use?

Yes, under medical supervision.

5. What are common side effects?

Nausea, diarrhea, urinary infections, and headache.

6. Can it cause hypoglycemia?

Yes, especially with other antidiabetic drugs.

7. What certifications does Taj Pharma provide?

WHO-GMP, COPP, CTD dossier, and more.

8. Is private labeling available?

Yes, Taj Pharma offers custom branding.

9. What is the shelf life?

Typically 24–36 months.

10. How should it be stored?

Below 25°C, away from moisture.

11. Does it require a prescription?

Yes, it is a prescription medicine.

12. Can it be exported globally?

Yes, with proper documentation.

13. What packaging options are available?

Blister packs and bottles.

14. Does Taj Pharma offer bulk supply?

Yes, for hospitals, distributors, and importers.

15. What is the dosage frequency?

As prescribed by a doctor.

16. Can alcohol be consumed with this medicine?

It is not recommended.

17. Is it suitable for elderly patients?

Yes, but with caution and monitoring.

18. Does it affect kidney function?

Regular monitoring is required.

19. What makes Taj Pharma unique?

Quality, affordability, and global reach.

20. How to contact Taj Pharma?

Through their official website or export team.